The medical research community on BrightTALK brings together medical and research professionals. Find relevant webinars on medical research, laboratory science, continuing medical education and more presented by recognized medical researchers. Join the conversation by participating in live webinars and round table discussions on the latest in medical devices, medical research practices and trends in the healthcare industry.
Sachin Dubey, Ph.D., Head of Formulation and Analytical Development at Glenmark Pharmaceuticals SARecorded: Mar 19 201935 mins
TRANSFORMATIONAL SCIENCE: MOVING FROM CHALLENGES OF HIGH CONCENTRATION PROTEIN FORMULATIONS DEVELOPMENT TO MEET THE NEEDS OF HIGH POTENT BISPECIFICS
Monoclonal antibodies (mAbs) have significantly contributed in the treatment of oncological and immunological disorders over last two decades. Next advancement in this line is the introduction of bispecific antibodies – molecules which can bind to two different receptors at the same time. Engaging T-cells to target tumor cells and eventually killing tumor cells have been clinically demonstrated by such bispecific antibody. Traditionally one of the key challenge for developing mAbs is to administer high quantities of mAbs, on the other hand bispecific antibodies are extremely specific and more efficient, which makes them highly potent – leading to a reduced dose. This turns the focus from developing high concentration formulations for mAbs to the development of low concentration formulations. Scientific challenges are of very different nature with surface adsorption being the key challenge; during drug product manufacturing as well as during clinical dosing a protein molecules encounters various different surfaces and preventing/controlling adsorption on any of these surfaces is important. Analytical methods are also required to be adapted for reliable low concentration measurement for the drug product as well as the diluted preparation for infusion in clinic.
Dr. Lisa Marzilli, Associate Research Fellow and group leader Mass Spectrometry at Pfizer, USARecorded: Mar 18 201940 mins
Sequence variants (SVs) are protein isoforms that contain one or more unintended amino acid substitutions. They can arise at a single amino acid site due to a genetic (RNA/DNA) mutation or at multiple amino acid locations, potentially due to translational errors, also referred to as misincorporations. The ability to detect SVs in protein biotherapeutics is critical due to their potential impact on structural/functional characteristics, safety and efficacy. Trypsin peptide mapping with liquid chromatography-ultrahigh resolution tandem mass spectrometry (LC-MS/MS) provides the ideal workflow for the detection, identification, and relative quantitation of both genetic and translational SVs. LC-MS/MS complements next-generation sequencing (NGS) of product cDNA and amino acid analysis (AAA) of cell culture medium during clone selection and process optimization in providing sensitive, comprehensive screening to strategically prevent/minimize SVs and ensure high product quality.
The occurrence of genetic SVs was evaluated using Sanger sequencing and LC/MS. In this work, mAbs with known high and low-level genetic SVs were studied at various cell culture conditions including scale, process and cell age. While scale and process had no significant impact on genetic SV levels, low-level SVs were found to decrease with cell age whereas high level SVs remained constant.
Multiple cell culture process options and the final process conditions are analyzed via LC-MS/MS prior to lock-down of the manufacturing process. Additionally, the cell culture medium (days in culture) for all small scale, pilot and clinical batches are analyzed by AAA to ascertain amino acid nutrient levels, which provides indirect monitoring of possible misincorporation situations. For mAbs with confirmed misincorporations, AAA and LC-MS/MS-peptide mapping results primarily correlated with amino acid nutrient depletion.
Charlotte Masy, Project Manager in global support GSK vaccinés and Donald Young, Sr. Product Manager at Thermo Fisher ScientiRecorded: Mar 14 201961 mins
Single Use technologies are more and more used close to final product leading to increase concern related to integrity. In this article we would like to share supportive data affecting integrity. Defect mode analysis has allowed us to build a risk assessment and a strategy on integrity. This strategy is very important for critical applications when single use are used after last sterile filtration or in process no sterile filtration is possible.
Several case studies supporting our approach will be shared showing the importance of addressing integrity in the context of use and taking all technical aspect into consideration. Finally, we will also present data analyzing the effect of such a strategy on lowering defect occurrence .
Keith Davis, Principle Scientist at PfizerRecorded: Mar 12 201921 mins
Coordinating PAT between development and manufacturing organizations is always challenging. When there are multiple development sites and numerous manufacturing sites, this becomes especially challenging. In order to help manage this in an efficient manner, we have established a PAT SME network with representation from the Manufacturing and the Development organizations. I will briefly introduce how this team facilitates PAT activities and attempts to add value to both organizations.
Ying Wang, Ph.D., Senior Scientist I, Manufacturing Sciences at AbbVie Bioresearch CenterRecorded: Mar 11 201939 mins
Title: Achieving Seamless Scale-Up and Technology Transfer – A Case Study in Single-Use Bioreactors
A systematic scale-up strategy is critical in enabling a rapid and robust technical transfer. For a program involving a CHO cell culture process, a combination of mass-transfer (kLa) studies, computational simulation and scale-down model experiments were used within this newly developed work-flow. Utilizing this approach, scale-up was successfully accelerated (
Introducing the Mendeley Data datasets API on SSRN! Learn more about early stage research and the integration of Mendeley Data datasets on SSRN encourages authors to upload the research data associated with their papers, allowing for greater transparency and reproducibility. SSRN authors get the credit for their research outputs, attract more citations, compliance with funder mandates data sharing, and more. SSRN readers easily access the data, can evaluate and follow the data connections, and use the data to create individual research.
John Jolliffe (Strategic Engagement, Adobe Document Cloud) & Viky Manaila (CEO, Trans Sped)Recorded: Mar 7 201937 mins
Pharmaceutical and Life Sciences companies are subject to unique legal and regulatory requirements that fundamentally impact the way they create and manage content and data. What role can digital signatures play in helping companies manage risk and comply with regulations for the management of clinical trials, securing patient informed consent, and the control of good manufacturing practices?
Join our live webinar to learn how:
• Life Sciences companies can achieve digital transformation in this highly regulated sector
• To comply with ICH E6(R2) guidelines on data integrity to avoid rejection of clinical trial data.
• To secure legally valid Informed Consent and comply with the new EU Regulations on clinical trials data.
• To work alongside signature solutions in non-regulated areas of life sciences companies.
• To achieve compliance with SAFE-BioPharma standards.
Divyaa Ravishankar, Industry Principal,Frost & Sullivan, Kyle Fetter, Executive Vice President, XIFINRecorded: Mar 5 201964 mins
What are the winning strategies for a laboratory to be successful? This webinar will focus on the state of the clinical laboratories market in the US, Canada, and Europe. Given the reimbursement cuts, it is essential to understand how this can impact the revenue-generating abilities of clinical laboratories and what strategies they can take now to keep the business profitable.
Frost & Sullivan invites you to join Divyaa Ravishankar, Industry Principal, Frost & Sullivan and Kyle Fetter, Executive Vice President & General Manager of Diagnostic Services, XIFIN, for the webinar: Future of Clinical Laboratories—Winning Strategies & Emerging Growth Opportunities. The event will provide an overview of the current state of clinical laboratories and recommendations for future success followed by an interactive, live question-and-answer session.
• Understand what is driving business for clinical laboratories and what will change in the future
• Learn how are clinical laboratories adjusting to the declining reimbursement situation
• Gain insight on ways a data-driven approach can help laboratories increase efficiency
• Better understand how blockchain applies in the world of clinical laboratory services testing
Lars Hovmand-Lyster of Novo Nordisk GPO and Ernest Jenness of MilliporeSigmaRecorded: Mar 5 201976 mins
BPOG Risk Based Approaches To Use Of Closed Systems In Renovations Of Existing Biopharma API Facilities
Companies often experience regulatory challenges during inspection of aging facilities, requiring them to initiate projects to optimize product protection and updating to current standards for classified areas for biopharma manufacturing. For a long time the company response have been to improve the existing classified areas or maybe even upgrading to a higher grade of classification. However, it may be more appropriate, and improve product protection, to instead implement the use of closed system processes and downgrade room classification during these facility renovation projects. If closed systems are fully utilised, then a CNC space can be used. As well as reducing complexity of operations, this will reduce capital and operating costs.
This presentation elaborates the work of BPOG members to harmonize the use of closed systems and define risk based tools and approaches to evaluate appropriate room classification across the Biopharmaceutical industry.
Prof Dr EMD (Ed) Schuuring & Prof Dr HJM (Harry) GroenRecorded: Feb 28 201956 mins
Join Dr. Ed Schuuring and Dr. Harry Groen, University Medical Center Groningen, The Netherlands, to explore the role of immunohistochemistry (IHC) in the assessment of ALK rearrangements in non-small cell lung cancer (NSCLC), with a focus on the binary algorithm and comparison with fluorescence in situ hybridization (FISH). Clinical implications for ALK IHC vs. FISH and treatment options for ALK inhibitors will be discussed including side effects and overall as well as intracranial efficacy.
Come one, come all to the troubleshooting gallery as we learn sure-fire techniques to troubleshoot IHC stains. Inappropriate stains impact patient care, slow your lab down, and waste reagents, all of which cost your lab money, time, and peace of mind. This workshop will cover common histology and immunohistochemistry protocols, paying close attention to how each step influences stain quality. We’ll take aim at the root cause for most stain issues and set our sights on the red flags to look for when troubleshooting. We’ve got you covered from specimen collection to cover slipping. Too Light, Too Dark, Background, No Stain and the rest of the outlaws won’t stand a chance. You’ll mosey out of this workshop with a thorough understanding of how histology and immunohistochemistry work to produce a quality stain and the tools you will need to efficiently troubleshoot the most common stain issues. Giddy up and count yourself among the ranks of ‘Sharp Troubleshooter’ for your lab.
Dr Diana Stanley, Deputy Editor of The Lancet Respiratory MedicineRecorded: Feb 26 201944 mins
Join Dr Diana Stanley, Deputy Editor of The Lancet Respiratory Medicine, to learn about:
• The Lancet family of journals’ peer review process
• What Lancet editors are looking for in a submission
• Strategies for preparing your manuscript for submission to a premium publication
Lawrence De Belder, Senior Principal Engineer at Johnson and Johnson and Richard Steiner, Business Development Manager at GEARecorded: Feb 26 201981 mins
Continuous manufacturing for Oral Solid Dose drug products has the potential to generate benefits in many different areas of the product life cycle. It will help to improve control and understanding, increase development and transfer speed, assure shorter cycle times, and reduce development, transfer and operational cost.
If we look at the products which have been approved for commercial production, we see differences in technology, approach, and business case drivers. The main interest is coming from larger pharmaceutical companies, but also generic companies and CMO’s start to invest or have intentions to do so.
Before implementing a continuous manufacturing process, a number of strategic choices have to be made: start off immediately with new products or learn by converting a legacy batch product into a continuous process without the critical deadline of a launch on your path. A clear development and deployment strategy will help to guide for important choices early on.
This webinar will give an overview of the different elements that can drive the business case of a continuous manufacturing project, and which strategies could be used to deploy this wonderful technology throughout an organization.
Ru Zang, Associate Director at Mersana Therapeutics and John Bonham Carter,Project Line Lead at RepligenRecorded: Feb 25 201976 mins
EFFECT OF CELL CULTURE PROCESS CHANGE FROM FED-BATCH TO CONTINUOUS ON PRODUCTIVITY AND PRODUCT QUALITY
Integrated continuous bioprocessing has attracted a growing interest due to its potential to improve agility and flexibility in the manufacture of therapeutic proteins. To convert an existing fed-batch cell culture process to continuous, or perfusion, the major technical hurdles include maintaining steady state cell culture performance and generating product with comparable product quality attributes. In this presentation, we evaluated three molecules including a fusion protein, an aglycosylated monoclonal antibody (mAb), and a glycosylated mAb. Steady state culture at high cell density was achieved for all three molecules, which allows the delivery of products with consistent product quality and adequate productivity. However, as compared to fed-batch processes, product quality and cell specific productivity differences were observed in perfusion cultures. Further studies indicated that it was feasible to modulate product quality in perfusion process by adding process levers in culture medium. It was also feasible to increase cell specific productivity through medium and process optimization. This presentation provides an insight into the product quality and productivity differences between traditional fed-batch and perfusion cell culture processes and potential approaches to addressing these differences.
Sean Donnelly (Econsultancy), Toby Donnison (Pharma Lead - Adobe), and Rupert Wills (Solutions Consultant - Adobe)Recorded: Feb 21 201954 mins
The 2018 Digital Trends report released by Adobe & Econsultancy found that only 5% of healthcare and pharma organizations reported being digital-first. Yet in today’s digital world, there has never been a better time for the Pharma industry to innovate and improve health outcomes whilst driving business performance. Technology has sparked a revolution across all functions, from research and development to sales and operations. However, meeting these demands is not without its challenges. The unique nature of the pharma and life sciences industry means that it faces issues that other businesses do not have to grapple with. There are complex supplier networks, growing regulatory requirements and increasing pressure to reduce costs – so what can digital leaders do to effect change quickly?
Join Econsultancy & Adobe in this webinar to learn:
• The reality of the digital first challenge and the trends causing complexity.
• How technology is shaping the future and the opportunities for digital agility & efficiency.
• How Merck transformed time consuming business processes though digital workflows – accelerating business, and improving the employee & customer experience.
• How electronic signatures can digitally transform your documents and workflows, accelerating an organisations digital transformation journey.
• How to ensure you stay compliant with regulations including a live demonstration the BioPharma module (covering Title 21 CFR Part 11)
Literature is one of the essential sources to identify high quality adverse drug reaction (ADR) reports. Regulatory authorities require companies to monitor major international publications through databases, as well as local, non-English content sources in each of the countries where the drugs are marketed. In November, 2018, Embase introduced the first non-English content – French Local Language Module, which is designed to screen, review and monitor French literature for pharmacovigilance.
In this webinar, Embase product manager Iveta Petrova will discuss:
-The challenges in Local Literature Monitoring process for pharmacovigilance
-The concepts of Embase French Local Literature Module
-How to use this module in Embase.com to build effective searches to identify the mention of drugs and ADRs in French journals
About the speaker:
Iveta Petrova holds a Ph.D. from Leiden University for research done on Wnt signaling in the nervous system. She joined the Embase team at Elsevier as part of the Content quality department. For 2 years she was responsible for writing and updating the indexing guidelines, as well as monitoring the quality of indexing. One year ago she joined the Product management team of Embase. Currently her tasks include continuous engagement with customers and market research to further improve and develop tools to support them in their daily responsibilities, specifically the enhancement of evidence-based medicine, pharmacovigilance and medical device clinical evaluation and safety.
Sune Klint Andersen, Janssen Pharmaceutica & João Vicente Senior Scientist - Particle Engineering Team Leader at HovioneRecorded: Feb 19 201977 mins
Spray drying is a continuous and scalable manufacturing process commonly used in the pharmaceutical industry. Due to its scalable and continuous nature it is possible to apply Quality-by-Design (QbD) and Process Analytical Technologies (PAT) early on in the development of a spray drying process.
Knowledge gained from QbD e.g. Design-of-Experiments (DoE) and PAT increases process understanding and the knowledge can be readily applied when scaling up the process and in production scale application of PAT i.e. especially with respect to the control strategy.
The Webinar will discuss the application of QbD early in the development and how the obtained knowledge can be used to optimize transfer of the spray drying process to production scale including PAT strategy.
Erik Nordkamp, GM UK, Pfizer, Dr Keri Torney, Deputy Director Life Sciences, NHS England, Angela McFarlane, IQVIARecorded: Feb 7 201973 mins
Brexit uncertainty isn’t going away any time soon – but it’s important to remember that the UK government has already set out two plans for the future shape of the country’s healthcare industry: the second Life Sciences Sector Deal and the long-term plan for the NHS.
With these two plans in place there are plenty of opportunities for the industry and the government to work together to keep the UK at the top of the international life sciences sector – and perhaps reach even greater heights.
This pharmaphorum webinar, held in partnership with IQVIA, will analyse the current and future landscape for UK life sciences as well as what steps have been taken so far to boost the sector.
Panellists from across the industry will look at the challenges presented by the current situation with Brexit and how the 10-Year Plan and the Sector Deal 2 (or 2018) play into this. They will discuss the positive steps taken by the government to prepare NHS innovation for a radically different future and make sure the UK remains an attractive location for ongoing inward investment from global pharma.
Topics to be covered include:
•Highlights of the 10-Year Plan and the second Sector Deal
•Progress with the current Life Sciences Industrial Strategy, the Sector Deal and plans for 2019
•The NHS innovation uptake agenda
•Maintaining UK attractiveness for inward global pharma and biotech investment
Nitin Naik, Unmesh Lal, Khushbu Jain, Fred Mao, Barbara Gilmore, Frost & SullivanRecorded: Feb 6 201974 mins
The Life Science industry is in a state of flux. While recent years have seen the advent of multiple novel technologies—such as IVF, CRISPR-Cas9, virtual clinical trials, and liquid biopsy—the industry today stands at a crossroads with challenges in scaling up and commercializing such technologies. The industry has now come to terms with new, path-breaking life science technologies that are helping make precision healthcare a reality. Chinese investments into the US biopharma industry jumped to $4.5 billion in 2018. An exclusive fireside chat with our US and China analysts will uncover trends in cross-border investments and growth opportunities in these two markets.
• Establish the leading factors that will influence the size and direction of the global life sciences market in 2019.
• Build clarity on technology developments in the global life sciences market in 2018 that will have an impact during 2019.
• Identify the business models used to commercialize and distribute novel life science solutions.
• Discover the key growth opportunities and strategic imperatives for companies in 2019.
Dr Xin Bu, Principal Scientist, Bristol-Myers SquibbRecorded: Feb 5 201943 mins
Dissolution is one of the critical quality attributes for solid oral dosage forms, typically tablets and capsules. In addition as a quality control (QC) test to release commercial products, dissolution is often used as a comparative test to 1) apply biowaiver for lower strength(s) when multiple strengths of one product with the same or similar formulation are marketed, or 2) support post approval changes. In these cases, in-vitro dissolution test is used in place of in-vivo bioequivalence study to establish equivalency between products of different strengths or pre- and post-change. Guidances provided by major regulatory agencies, the United States Food & Drug Administration (US FDA) and European Medicines Evaluation Agency (EU EMEA) are often followed by many countries around the world. However some countries/ regions, such as Australia, Japan, China, Taiwan and Korea have their own country specific guidances. The dissolution requirements by the FDA and EMEA are generally similar, and depend on the type and level of changes as outlined in the relevant guidances. The requirements from other mentioned countries are often significantly different from that of US and EU, and different from each other. For products marketed globally, it’s prudent to understand the differences amongst the different country requirements when applying post approval changes using dissolution to demonstrate equivalency. Several sets of comparative dissolution studies may have to be conducted in order to satisfy all regulatory agencies. This presentation compares differences in dissolution testing requirements among the listed countries and provide examples to illustrate how for conduct studies to comply with the relevant guidance(s).
Danyi Wen, Shanghai LIDE Biotech, Stefan Jellbauer, Mitra Biotech, Lakshmi Santhosh Maithel, RepositiRecorded: Jan 29 201961 mins
The prevalence of cancer is currently predicted to be higher than ever. Current statistics show 1 in 2 people in the UK and 1 in 2 men/1 in 3 women in the US will experience it at some stage in their lives. And yet the picture for patients is an improving one.
The move towards immunotherapies heralds much promise and this is potentially just the beginning. As cancer is understood increasingly not by type, or even tumour type but specific mutation the era of personalised oncological therapies is visible.
To delve further into this pharmaphorum is pleased to present an exclusive online discussion.
Bringing together experts at the cutting edge of this field it aims to interrogate where we are in terms of this shift towards personalised oncology, what this means in terms of the development pathway and looks at the approaches which could (and will) fully evolve the way that cancer treatments are developed in terms of efficacy, approach and outcome.
this free to attend event will cover a number of topics critical to the future of oncology including:
•The changing face of cancer: how do we define it now?
•Personalised medicine in practice – where are we now in cancer?
•What are the implications from these changes for clinical trials?
•How the shift towards cancer as a phenotype/genotype is being applied in clinical trials and how they are run
•What are co-clinical trials and why could they hold the key to answering unmet need in cancer treatment and beyond into broader drug development?
•Modelling for the future of cancer – can this be done for personalised therapies?
Franziska Wienholz, Scientific Support Specialist, Corning Life SciencesRecorded: Jan 28 201944 mins
Cell Culture Masterclass: A 10-Point Plan to Prevent Contamination
All cell culture laboratories have experienced it: cell culture contamination and its inevitable loss of material. Contaminants may be biological or chemical, visible or invisible, destructive or seemingly benign, but in all cases, they adversely affect both the use of your cell cultures and the quality of your research.
Identification and, even better, prevention of contamination are crucial for ensuring high-quality research. This expert webinar will present an overview on how to prevent, recognize and tackle contamination by introducing good lab practices and targeted interventions.
If you work with cell culture daily or are interested in setting up prevention strategies to minimize contamination, then join SelectScience and Franziska Wienholz, scientific support specialist of Corning Life Sciences, for this educational masterclass. Franziska will share a 10-point plan to prevent contamination and provide a comprehensive refresher on all aspects of cell culture.
Key learning objectives:
Understand the basic rules of cell culture
Know how to properly manage cell lines to prevent cross-contamination
Be able to implement a 10-point plan to contamination prevention in your laboratory
Who should attend:
Scientists working with cell culture on a daily basis
Cell culture managers who are interested in setting up programs to prevent contamination and determine authentication of cells
Researchers that struggle with contamination issues
Dr. Richard E. Eglen, Vice President and General Manager, Corning Life Sciences.Recorded: Jan 28 201962 mins
Advances in three-dimensional Cell Culture in Drug Research, Discovery and Biologic Manufacture.
Cellular research is optimal when using physiologically relevant cell phenotypes and genotypes of human origin. This assertion has accelerated the adoption of primary cells, stem cells, and, increasingly, patient-specific cells in drug discovery. Over the past five years, technological improvements in 3D cell culture technology, to better mimic in vivo physiology, have also advanced. This is true not only in the areas of cancer and neurological research, but also in the assessment of clinical candidates for metabolic and toxicological liabilities. Furthermore, 3D cell culture is facilitating novel approaches to both the scale-up and manufacture of biologics, including those used in immuno- and stem cell-based therapies.
Are you a scientist interested in 3D cell culture? Join this expert webinar, in which Dr. Richard Eglen will discuss the importance of 3D cell culture in drug discovery and manufacture and how technological improvements are causing significant advancements in this field.
- The existing and future impacts of 3D cell culture technology on fundamental research
- The impacts of 3D cell culture on drug discovery and manufacture, particularly in the context of using phenotypically relevant cells?
- The potential for spheroids, organoids, scaffolds, and hydrogels in cellular research and compound identification, screening, and development?
Helen Parfitt, Head of Therapy Watch, Research Partnership, Mariel Metcalfe and Mark Hollis, Research PartnershipMar 21 20193:00 pmUTC75 mins
Rheumatoid arthritis (RA) has been a major growth driver for the pharmaceutical industry over the last 15 years, led by AbbVie’s blockbuster anti-TNF inhibitor treatment Humira (adalimumab).
The emergence of low-cost biosimilar versions of Humira and the new janus kinase (JAK) inhibitors, are shaking up a once-stable market.
Although there are only two drugs in this class available in the region – Eli Lilly’s Olumiant (baricitinib) and Pfizer’s Xeljanz (tofacitinib) – this is not likely to be the case for much longer, as several other candidates reach late-stage development.
Analysis of Therapy Watch data, a real-time' syndicated market tracking tool from Research Partnership, shows that JAK inhibitors have already made a strong impression in the European RA market, where their convenient oral administration advantage may override cost considerations that would otherwise favour biosimilar uptake.
This pharmaphorum webinar, held in conjunction with Research Partnership, will use the latest intelligence from both physicians and patients to look at emerging trends in the RA market, how these will shape the RA market of tomorrow and how companies can best position themselves for future success.
This webinar will provide an opportunity to interact with the panel about how companies can best harness the potential of this increasingly complex, but highly rewarding, market.
Topics to be covered include:
The European RA market
Current status and market situation of JAK inhibitors (key EU5 countries)
Uptake curve of JAKs compared to other new entrants and biosimilars
Profile of physicians prescribing JAKS
The future of new classes of JAK inhibitors
Tami Freeman, Anna Demming and Susan CurtisMar 21 20193:00 pmUTC60 mins
Thank you for your interest in becoming a student contributor for Physics World. This webinar will provide you with an overview of Physics World and IOP Publishing, plus we will also explain how you will be able to contribute your own content to the site.
Ken Wong, Deputy Director at Sanofi Pasteur and Don DeCou, Extractable and Leachable Technology Manager at West PharmaMar 25 20192:00 pmUTC75 mins
Extractables and Leachables have been used interchangeablely for too long. Are we still confused?
Presented by Ken Wong, Deputy Director at Sanofi Pasteur
Followed by Building a Bridge to Leachable Assessment
Extractable data is a practical guide to support selection of components used in drug product container closure systems and to understand potential for leachables. Standardization of extractables testing is a topic of interest in the pharmaceutical industry and debate in the scientific community, however; the challenge for standardized tests is to verify the extent of data and type of extractions needed to drive the best decisions. As a starting point, comparative extractable data can indicate differences, but this may not be relevant to end use application. According to USP informational chapter on extractables assessment, the design of an extraction study is dictated by the purpose of the extractables assessment. This presentation will put into practice the overarching principles of USP for developing extractable study designs. Three case studies will be given representing risk of leachables across product lifecycle. Data will be shown related to the selection process, post approval changes, and considerations for biologic product quality.
Presented by Don DeCou, Extractable and Leachable Technology Manager at West Pharmaceutical Services
Perrine Rouel, Janssen Pharmaceutical Companies of Johnson & Johnson and Tom Jeffery, Sartorius Stedim BiotechMar 27 20193:00 pmUTC75 mins
FROM EARLY STAGE TO LATE STAGE DEVELOPMENT: HOW TO CHARACTERIZE A PERFUSION-BASED VACCINE PRODUCTION PROCESS USING QBD?
The biopharmaceutical industry is known for its long time-to-market and for requiring large resources and time investment for product development. The type of activities required at the start of a biopharmaceutical product development focus mainly on designing a suitable process for manufacturing as rapidly as possible material to be tested in pre-clinical and clinical trials. This is followed, upon success in early clinical trials, by a process optimization phase, which aims at increasing yields while reducing costs-of-good. Moving on towards late stage development, the manufacturing process needs to be characterized, meaning that its robustness to produce the desired product quality when operated within certain process ranges needs to be demonstrated. This phase requires large numbers of development batches using elaborate analytical methods and advanced statistics, in order to fully study the relations between the manufacturing process and product quality.
Janssen Vaccines has transitioned over the last 3 years from early stage process development to full late stage development programs. In this presentation, we present the implications of such a transition, with the case-study of the QbD-based characterization of a perfusion-based PER.C6® cell culture process for Adenovirus vaccine production at Janssen Vaccines.
We will introduce Chromassette® and an application example of an integrated rapid single pass process from harvest to purified bulk, a concept demonstrated by AbbVie. Chromassette is a stackable, single-use and pre-packed chromatography cassette with a supported bed, addressing the current key challenges in manufacturing. Chromassette enhances the separation capabilities of chromatography resins and combines it with the convenience of a modular cassette.
Dr Benoit Ramond, Head of Microbiology & Sterile Technology, Sanofi and Dr David Jones, Director at Rapid Micro BiosystemsApr 8 20198:00 amUTC75 mins
Today Pharmaceutical industry remains conservative for microbiology testing methods and has reluctance to develop and to use Alternative and Rapid Microbiological Methods (RMM) supported by a number of misunderstandings and prejudgments based on the following myths:
- RMM are not accepted by regulation authorities,
- RMM will never replace classical microbial methods,
- RMM will not offer return on investment (ROI),
- Data generated from RMMs will exceed current specifications and limits involving increase in batch rejections.
Nevertheless a movement is in progress for the use of new technologies and systems because classical microbial methods, in spite of their long return of experiences and their confidence for the regulatory point of view, have a number of disadvantages such as:
- Time to results in days to weeks,
- Results vary with microbial population, media, culture conditions,
- Lack of reactivity in case of exceeding limit results,
- Sensitivity could be insufficient giving underestimations in the contamination risk,
- Existence of confluent growth.
This webinar provides an overview of the current situation about RMM technologies, regulatory expectations, it proposes some initiatives facilitating the implementation of RMM including a strategy for validation and it gives a projection for the perspectives of the RMMs for the future.
Presented by Friedrich von Wintzingerode Global QC bei Roche Followed by Mathilde Arnault, Research Scientist at Merck KGaA,Apr 9 20198:00 amUTC75 mins
Large scale Production of Biologics is susceptible to microbial contamination because many manufacturing steps occur under non-sterile conditions in aqueous systems at ambient temperature or 2-8 °C under substantially neutral pH conditions. Regardless of where in the Drug Substance (DS) manufacture (manufacture of the Active Pharmaceutical Ingredient), or Drug Product (DP) manufacture (manufacture of the Final Drug, e.g. formulated mAbs filled in vials or syringes) they occur, microbial contaminations can have a significant impact on product quality and patient safety. Even after bioburden removal by 0.2 µm filtration subcellular microbial components like toxins, lipopeptide/lipoproteins, flagellin, bacterial and fungal DNA, cell wall polysaccharides, extracellular proteases or endoglycosidases remain in the product. Those microbial components potentially lead to toxic, allergic or inflammatory responses in humans or product degradation or modification. The CCAB approach described here enables a comprehensive assessment of these risks.
Monocyte Activation Test: a powerful tool to assess pyrogenic risk in pharmaceutical process
Microbial risk in pharmaceutical process is not limited to viable microorganisms. Subcellular components from microorganisms remaining from the production process can be source of pyrogens, compromising product quality and patient safety as these substances are not eliminated by classical filtration or sterilization steps. According to the European Pharmacopeia, chapter 5.1.10, a risk assessment has to be performed to justify the method to be used for pyrogen detection: bacterial endotoxin testing is not sufficient if the presence of non-endotoxin pyrogens in the production process cannot be excluded.The Monocyte Activation Test (MAT) can detect both endotoxin and non-endotoxin pyrogens in one test. Supported by many regulatory bodies, the robust MAT assay provides sensitive results based on the human immune reaction and can be a powerful
Hossein Sahraei, Data Scientist, Sanofi PasteurApr 10 20192:00 pmUTC75 mins
The utilization of Multivariate Data Analysis (MVDA) techniques at Sanofi Pasteur, Toronto site has demonstrated innovative capabilities for improved process understanding, control and diagnostics. Examples from several successful and high impact applications will be presented. These examples cover the application of MVDA techniques in multivariate process control, root cause investigations and process analytical technology (PAT). The areas of application include fermentation, downstream purification and product formulation stages.
Did you know that the incidence of liver cancer has tripled since 1980? Have you wondered what current antibodies are being used to label liver carcinomas by IHC? Or are you curious what antibody grids are used in the differential diagnosis of primary liver carcinoma? In this presentation we will discuss the markers used in detecting liver carcinoma as well as other antibody grids that can be ran to aid in the identification of primary liver carcinoma.
Vasilis Tsaousis, PhD., Medicon HellasApr 11 20194:00 pmUTC75 mins
Latex enhanced immunoassay reagents can be adapted to automated biochemistry bio-analyzers ,equipment available in every modern biochemistry laboratory. Combining existing knowledge in the areas of antibody development and bead conjugation these reagents are suitable for the determination of proteins in patient samples. Their use can override the need for specific and expensive equipment necessary to perform these tests in the past. This talk will focus on the methods we could follow in the design of these reagents, the optimization of crucial factors in the development phase and the validation procedures to reach the expected analytical performance.
Daniel Christe, Innovation Advisor, ElsevierApr 17 201910:00 amUTC60 mins
When we think of Mendeley, we tend to think of the Reference Manager, but did you know that Mendeley can help you track research metrics like h-index and the number of times your papers are shared? Mendeley can also help you search for your next job or your next research grant.
Dr. Dheerendra PrasadApr 18 201912:00 pmUTC60 mins
The increasing number of diagnoses of brain metastases in asymptomatic patients – as a result of screening MRIs – has created the need for both durable control and prevention of cognitive decline in patients who are expected to have increasing median survivals. Since the mainstay of their therapy is systemic management, “Radiosurgery Now” represents the idea of immediate radiosurgery with the intent of avoiding interruption of systemic management.
This webinar will discuss the impact of delay in radiosurgery on tumour growth and the benefits of repeat radiosurgery for the long-term preservation of cognitive function. The linear and robust rapid workflow of the Leksell Gamma Knife® Icon™ is ideally suited to this concept.
John Wasylyk, Senior Principal Scientist at Bristol-Myers Squibb and James Carriere, Product Line Manager at CoherentApr 26 20192:00 pmUTC75 mins
Low frequency Raman spectroscopy has been used to study various polymorphs and can be applied to the design of crystallization control strategy. Extending the low frequency spectral region to include the fingerprint region, provides access to collective vibrations of molecules in the amorphous and crystalline states and yields valuable insight when differentiation of various forms is quintessential. Whether during process development or production, low frequency Raman bands provide greater sensitivity for detecting the onset of crystallization and has allowed differentiation of crystal types when multiple forms are possible. Applying this to Quality by Design (QbD) studies brings an increase in process understanding leading to developing optimal control strategy and avoid the many pitfalls that can occur when scaled-up to the production environment. A recent applications of in-line crystallization processes provided insight into establishing the ideal crystallization control parameters. The parameters evaluated include temperature, mixing rate, seed levels and solvent variable. In-line and off-line QbD studies demonstrated both ideal and non-ideal conditions, ultimately yielding critical process knowledge. As a results of our studies, low frequency Raman has proven to be a valuable tool for at-line and on-line monitoring of active pharmaceutical ingredient crystallization and paves the way for robust production in a large scale facility.
Advances in gene editing technologies have generated a great amount of interest within the scientific community over the past few years. In addition to the ability to make precise double stranded DNA cuts virtually anywhere in the human genome, new variations of these tools show promise in the ability to activate or repress the expression of individual genes. Besides the obvious interest in clinical applications for these tools, there are practical uses of these tools for modifying and improving in vitro cell-based assays in areas such as preclinical ADME/Tox. This webinar will highlight these recent advances in gene editing technology and provide several examples of how this technology has been applied to ADME/Tox assays, including intestinal, hepatic and renal proximal tubule cell lines.
Mike Tobyn, Research Fellow at Bristol-Myers SquibbMay 2 20199:00 amUTC75 mins
The Pharmaceutical Industry has a strong need to develop knowledge from data. Although the latter is not at a premium in the Pharmaceutical Industry the former is, as always, at a premium. Multivariate data analysis (MVA) is a set of statistical data analytical methods which has been widely adopted within the Pharmaceutical Industry, and it has pre-eminence within the discipline.
The ability of MVA to provide validatable solutions within a Regulated Pharmaceutical environment has arisen because of its transparency and reproducibility, across a wide field of data sources. An ecosystem of software providers, allied with hardware solutions, means that the techniques are becoming widely understood and applied.
Key to this adoption has been the ability of MVA techniques to meet not only direct Regulatory Guidance, but also Industry Standards such as ICH Q8 and initiatives such as Quality by Design.
A wide body of literature is now available which explains how to use the technique appropriately, so that these Guidances can be met, leading to robust solutions
Dr Friedrich von Wintzingerode, Senior Manager, Global Analytical Science & Technology (gASAT) Microbiology, Global QC bei RoMay 3 20198:00 amUTC75 mins
Since first reported by Chen and Vinther in 2013, the phenomenon known as low endotoxin recovery (LER) has been broadly observed in certain matrices commonly used for biologic formulations and certain therapeutic proteins. LER is defined as the inability to recover >50% activity over time when endotoxin is added to an undiluted product. LER is a temperature-and time dependent process, which usually does not occur immediately but after several hours to several days. Compendial LAL method qualification (Bacterial Endotoxin Test = BET per USP /EP 2.6.14/JP 4.01) does not include defined hold time conditions, which may explain why LER has not been detected by following compendial BET guidance. Because of the potential impact to patient safety and complex nature of the LER issue, the Parenteral Drug Association (PDA) published a Technical Report (TR) on LER. This TR was authored by subject matter experts from academia, U.S. FDA, biopharmaceutical companies, and reagent suppliers/testing contractors. The PDA Technical Report on Low Endotoxin Recovery provides a science-based and data-driven strategy in dealing with the LER phenomenon. The author of this article, who acted as co-lead of the TR authoring team, provides first hand information that allows companies to develop product specific solutions to the LER problem.
Dennis Douroumis, of University of Greenwich and Dr.-Ing Margarethe Richter, Pharma Application Specialist at Thermo FisherMay 7 20191:00 pmUTC75 mins
Full Title: Employing Hot Melt Extrusion As a Cost Effective Method of Increasing Solubility Of Water Insoluble API’s
• Identifying the appropriate excipients for HME processing of water insoluble drugs
• Using novel excipients to achieve increased dissolution rates (Granulation)
• Extrusion with polymeric carriers for the development of solid dispersions
• Co-crystallisation of water insoluble drugs
In the last 20 years Hot Melt Extrusion (HME) has seized the attention of pharmaceutical industry for the development of pharmaceutical solid dispersions. It is a versatile processing technology, which can effectively increase the solubility/dissolution of water insoluble active pharmaceutical ingredients (APIs). The processing of a wide range of materials including inorganic excipients, hydrophilic polymers or cocrystal formers renders HME advantageous compared to conventional formulation technologies. In this review article we discuss recent trends for increased solubility/dissolution of water insoluble actives by using HME and predictive tools for process optimisation.
As a well-known process in polymer industry hot melt extrusion (HME) is approaching pharmaceutical manufacturing. HME allows innovative formulations of solid oral dosage forms. Its main advantage in pharmaceutical applications is the possibility to enhance bioavailability of a drug, i.e. to produce solid dispersions of the active pharmaceutical ingredient (API) in the polymer matrix. The main concern of the formulator is to achieve the appropriate release profile (immediate or sustained release) or improved bioavailability of the API. The presentation gives an introduction into HME technology as an alternative to spray drying. It includes several case studies related to HME for solid oral dosage forms. In addition to solid oral dosage forms hot melt extrusion (HME) can be used for novel delivery methods. The presentation gives an overview on possible applications including examples and case studies.
Ekta Mahajan, Genentech/RocheMay 8 20192:00 pmUTC75 mins
Single Use technology is being used more each year in the biotechnology industry. However, extractables and their potential impact on product and patients continue to be one of the biggest challenges. The challenge is augmented by the lack of standardized methodology for suppliers to execute extractable studies that meets end user requirements. The end users are responsible and required by law to assess the impact of extractables and leachables on overall Product Quality and Safety. Due to lack of a standard, customized data had to be generated for/by each end users. This resulted in long lead times, higher costs and inefficient utilization of resources. Typically, the data generation and qualification of single use component can take up to a year, which can impact implementation of single use. BioPhorum Operations Group (BPOG) developed a standardized protocol9 for generating extractable data that would meet user requirements and simplify/reduce implementation time within industry. A standardized protocol gives confidence to suppliers that testing performed by them would meet end user requirements and enable faster implementation. Some suppliers shared the BPOG vision and proactively tested their single use components using BPOG protocol, which has helped expedite the use of their products.
Charlie Whelan, Vice President of Consulting, Transformational Health, Americas, Frost & SullivanMay 14 20193:00 pmUTC75 mins
For most cities and states, the healthcare technology and biosciences sector is one of the most attractive industries of the future that can grow their communities. However, that attention attracts significant competition among players seeking to expand in a field that is highly complex. How should your community address this industry, and what is the best path to nurturing start-ups, retaining existing employers, attracting new companies and encouraging workforce development?
• The healthcare technology and biosciences market is large and complex. Learn how the industry is structured and which segments might align best with your community.
• Cities and states across the country are all competing to grow their own biosciences economies. Find out what types of programs and strategies are the most effective.
• Come away with a simple model for assessing your own community’s strength relative to the healthcare technology and biosciences market.
Marina Kirkitadze,Head of Process Support & PAT Platform, Analytical Sciences at Sanofi PasteurMay 21 20192:00 pmUTC75 mins
The topic of this presentation is characterisation of visible and subvisible particles in protein and viral vaccine formulations. Visible and subvisible particles were found to be inherent to the product, and were analyzed by several methods including MFI, DLS and PALS.
Dr Udayanath Aich, Associate Director at Bristol-Myers SquibbMay 22 20192:00 pmUTC75 mins
Real time monitoring and in-time release of products create a demand to move testing from QC release (off-line) analysis to the manufacturing shop floor (in-line, on-line or at-line monitoring), in order to address Biopharmaceutical manufacturing goals of reducing speed, cost and maximizing quality of product. BioPhorum Operations Group (BPOG) published a Biomanufacturing Technology Roadmap in July 2017 with the active collaboration of Biopharma industry representatives and supply partners. As part of implementation of roadmap strategy, BPOG’s ILM-RTR technical forum team is developing User Requirement Specifications (URS) for prioritized CQA’s and CPP focusing on the critical control points and future requirements of real time release (RTR). The URS documents will promote effective development of desired Short, Mid and Long term technologies by the innovators and supply partners.
Dr. Udayanath Aich is an Associate Director at Bristol-Myers Squibb. He previously was a Principal Scientist at Sanofi-Genzyme. He has extensive experience and management skills in analytical chemistry, high throughput technologies and process analytical technologies (PAT). Dr. Aich completed his Ph.D. from Indian Institute of Technology Madras in the area of Chemical Biology. After completion Ph.D., he has joined in Biomedical Engineering Dept of Johns Hopkins for his postdoctoral study in the field of cell engineering, glycoengineering and structure-activity relationship. Subsequently, he has decided to move to Massachusetts Institute of Technology to gain extensive skills in the area of Biopharmaceutical characterization and drug development. In 2011, Dr. Aich joined at Thermo Fisher Scientific in the chromatographic and mass spectrometric division to broaden his extensive analytical skills. Before Sanofi-Genzyme, Dr. Aich worked as Investigator at GlaxoSmithKline in the area of protein and glycans characterization, process analytics and structure-function study.
Dr. Michael J. Miller, President of Microbiology Consultants, LLCMay 23 20192:00 pmUTC75 mins
Gene and cell therapy products, also known as advanced therapy medicinal products (ATMP), present unique challenges for Quality Control release testing due to their very short shelf life, fast medical need for dosing patients and limited availability of product for sterility testing. As such, meeting the requirements for existing compendial sterility test methods is often difficult, if not impossible, to achieve.
This webinar will focus on recent regulatory policy changes, compendial recommendations and industry best practices for alternative approaches to sterility testing of gene and cell therapy products. A review of Ph. Eur. 2.6.27 (Microbiological Examination of Cell-Based Preparations), USP informational chapter (Rapid Sterility Testing of Short-Life Products: A Risk-Based Approach), EU Guidelines on Good Manufacturing Practice Specific to ATMPs and FDA’s Guidance on Chemistry, Manufacturing, and Control (CMC) Information for Human Gene Therapy Investigational New Drug Applications will be provided.The information provided will be supported by case studies on selecting a relevant sterility test sample and an appropriate sample size for the release of gene and cell therapy products.
Chemiluminescent immunoassays (CLIAs) offer one of the best solutions for the quantification of low concentrations of specific analytes from a complex mixture for in vitro diagnostic industry. The assay format is similar to enzyme-linked immunoassays, usually based on heterogeneous assays where antibodies or antigens are immobilized on a solid phase but one of the components is conjugated with a chemiluminescent label.
The benefits of CLIAs can be enhanced using magnetic beads as a solid platform which improves the separation of the un-bound reagents and reduces the interferences using a magnetic field.
The CLIA assays based on magnetic beads together with chemiluminescent tagging of immunoreagents are widely used in high throughput automated platforms obtaining an amplified signal and decreasing the matrix interferences. The complexity of these type of immunoassays rely on the optimization of several components and parameters. The critical points are highly related to the type of immunoassay format that best suits the desired specifications, magnetic beads selection and conjugation conditions for magnetic particles and chemiluminescent labelling parameters.