Get powerful life science insights from influential experts. Connect with thought leaders and colleagues to get the most up-to-date knowledge on strategies and initiatives to accelerate the transformation of U.S. and global health care from a volume- to value-based marketplace.
View the Future of PLM today! See a live and interactive demonstration of Propel’s game-changing cloud PLM solution Join us on Thursday April 11, 2019 at 10am PT / 1pm ET to: See how easy it is to use and customize
Vasilis Tsaousis, PhD., Medicon HellasRecorded: Apr 11 201947 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.
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.
Information found in the biomedical literature is a significant source for every stage of the medical device life cycle, from concept and design through clinical trials to release and reimbursement, as well as post-market surveillance.
In June 2016, the updated Medical Device Clinical Evaluation Report (CER) guidelines came into effect (Revision 4 of MEDDEV 2.7/1), detailing where and how to search for literature and how to record the process of collecting, appraising and analyzing the items found.
In this session, Elsevier's solution manager Xuanyan Xu will demonstrate how Embase is especially suited to help Medical Device manufacturers prepare CER, including:
- How to design effective literature searches for Clinical Evaluation reports using the PICO search form in Embase;
- How to build a more comprehensive search using Emtree terms and synonyms;
- How trade name and manufacturer name indexing supports analyses of devices already on the market;
- How to find mentions of adverse device reactions in the literature for effective post-market surveillance (PMS) reporting
Andrew Reiser, Mountain Point; Miguel Tam, PropelRecorded: Apr 9 201953 mins
How the Cloud Helps Sales, Engineering and Operations to Create Winning Quotes
Changing customer expectations, new types of competitors, and more complex products are endangering the entire business model of engineer-to-order (ETO) companies. ETO companies need to change now because the old game of throwing information back-and-forth between engineering, sales and operations is no longer good enough.
Customers are no longer satisfied with mediocre response times, lack of project visibility and disjointed communication across sales, engineering, and operations. Blaming other teams for lower margins from poorly coordinated quotes doesn’t help with lost business to more nimble competitors.
In this webinar, Andrew Reiser of Mountain Point, a Salesforce and manufacturing consulting firm, and Miguel Tam of Propel, a Salesforce manufacturing software provider, will share how best-in-class companies are embracing the cloud to work better together, with internal teams and customers, and win more business.
This live webcast will cover how cloud applications like Propel and the Salesforce Sales Cloud can create an integrated business process from initial customer request to design discussions to winning customer quotes.
Join this webinar to see:
- How a unified cloud platform can tie sales, engineering and operations processes
- Real-world customer examples that have seen product throughput grow by 500%
- A live demonstration of how Mountain Point, Propel and Salesforce uniquely support modern Engineer to Order business processes
Sergio Barberan-Soler, Ph.D., Director of Sequencing Technologies, SomaGenics, Inc.Recorded: Apr 9 201956 mins
The ability to accurately quantify all microRNAs (miRNAs) in a sample is not only important for understanding miRNA biology, but for the development of new biomarkers and therapeutic targets. SomaGenics has developed the RealSeq®-AC library preparation kit – a new method for preparing miRNA sequencing libraries that involves ligating the miRNAs with a single adapter and circularizing the ligation products. When compared to other methods, the RealSeq®-AC kit provides greatly reduced miRNA sequencing bias and allows the identification of the largest variety of miRNAs in biological samples. This reduced bias also allows robust quantification of miRNAs present in samples across a wide range of RNA input levels.
Presented by Friedrich von Wintzingerode Global QC at Roche Followed by Mathilde Arnault, Research Scientist at Merck KGaA,Recorded: Apr 9 201962 mins
Full Title: New Tools to Assess the Risk of Microbial Impurities in the Pharmaceutical Manufacturing Process
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.
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
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.
Adopt a Customer-Centric Approach to Reduce Risk with Post-Market Surveillance and Product Complaints:
Being customer-centric in the medical device industry isn’t just about personalized healthcare or integrating IoT feedback into your next generation of devices. Customer centricity has a major role in reducing risk with your post-market surveillance and product complaints process. By having a much more streamlined process to gather customer feedback - both positive and negative - medical device companies can lower risk, improve regulatory compliance, reduce errors and increase customer responsiveness.
In this webinar, Miguel Tam of Propel will focus on the importance of putting your customers first and integrating customer feedback directly into your product quality processes and design reviews.
Hear more about the following:
=> How medical device companies can reduce risk by tying CRM, QMS and PLM (Product Lifecycle Management)
=> Real-world examples of companies who have streamlined customer complaints, CAPAs and engineering changes
=> A live demonstration of how Propel helps with customer complaints and post-market surveillance
Seth Earley, CEO, EIS & Carla Pealer, Taxonomy Consultant, EISRecorded: Apr 3 201952 mins
Business agility rests upon a well-architected environment of business processes, workflows, and communications.
So how does taxonomy fit in? It’s everywhere - taxonomy is the foundational building block that improves efficiencies, collaboration, and cost reductions across the enterprise. And the more agile you are, the better opportunity you have to compete and win.
In this webcat you will learn:
• Industry-agnostic best practices to boost your bottom line and beat your competition through taxonomy design and semantic integration
• How taxonomy design enables customer acquisition, search relevancy, structured data, faster time to market, asset reuse, and more.
Speaker: Carla Pealer, Consultant, Earley Information Science
Mark Christiani, Miguel TamRecorded: Mar 28 201944 mins
View the Future of QMS today! Join us for a live and interactive demonstration of Propel’s game-changing cloud QMS solution. See how quality and complaint management can ease the burden of regulatory compliance for medical device and other regulated industries.
Miguel Tam, Propel and Joe Dunne, OnshapeRecorded: Mar 28 201953 mins
Companies have been integrating CAD and PLM for decades, so is there anything really different that cloud technologies can do? For over 20 years, integrating CAD systems like SolidWorks and Creo to PLM systems has helped mechanical engineers be more efficient. But what about everyone else who needs to see the latest product updates? That’s where the cloud comes in. With their brand new cloud CAD connector, Onshape and Propel are changing how companies can design, launch and sell. The newly launched Onshape and Propel connector not only helps mechanical engineers be more productive, it also allows everyone inside and outside a company to securely share product designs and data.
In this webinar, Joe Dunne, Head of Developer Relations at Onshape, Jayson Kadlecek, Product Manager at Propel, and Miguel Tam, VP of Marketing at Propel, will explain the benefits of an integrated cloud CAD and PLM solution. Joe and Miguel will walk through specific use cases that customers are exploring, and Jayson will do a live demonstration of how Onshape and Propel work for everyone to deliver amazing products.
They will show how Propel and Onshape can:
- Streamline creation of parts and assemblies from Onshape to Propel
- Synchronize product updates across CAD and PLM
- Better support business models like Engineer to Order
Note: Contact information from this webinar will be shared with Onshape.
Perrine Rouel, Janssen Pharmaceutical Companies of Johnson & Johnson and Tom Jeffery, Sartorius Stedim BiotechRecorded: Mar 27 201958 mins
Full Title: 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.
Modern cloud QMS solutions for medical devices provides closed-loop quality management with integrated product lifecycle management (PLM), CRM to speed products to market while maintaining regulatory compliance, all in the cloud.
Ken Wong, Deputy Director at Sanofi Pasteur and Don DeCou, Extractable and Leachable Technology Manager at West PharmaRecorded: Mar 25 201977 mins
Extractables and Leachables have been used interchangeablely for too long. Are we still confused?
The terminologies of “Extractable” and “Leachable” have been used interchangeably to describe test data from a study which fall in between a grey zone of typical “Extractable” or “Simulation” and “Leachable” study. During this webinar, we will explore to better understand what are the key challenges with case study and survey this grey area to capture the view of all participants.”
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
Brad Hinke, Director of Quality Services & Validation at PropelRecorded: Mar 21 201951 mins
If your company is thinking about buying software to help with product development and manufacturing, validation is a critical step for complying with FDA 21 CFR Part 11 and Part 820. But many firms often lack detailed expertise and experience to make sure their non-product software is validated. With lack of resources and direction, how can you make sure your software is validated at a reasonable cost.
Brad Hinke, Director of Quality Services & Validation at Propel will host a live webinar and provide guidance and best practices from real-life lessons on validation. Brad has worked with both small and large medical device firms in all aspects of validation and implementation.
In this webinar, learn the following:
- what software needs to be validated and lessons learned from past validation efforts
- frameworks for approaching validation
- steps you must do to be compliant with the FDA.
Seth Earley, Founder and CEO, Earley Information Science, Tom Davenport, author of The AI AdvantageRecorded: Mar 21 201948 mins
Artificial Intelligence (AI) for organizations of all sizes is becoming more practical every day. Many successful implementations are having subtle, but far reaching implications for companies across industries. In this roundtable we will discuss:
1. Where to begin looking for practical opportunities to leverage AI in your organization
2. How market forces are driving this evolution
3. Prioritizing incremental wins over big hit projects
Helen Parfitt, Head of Therapy Watch, Research Partnership, Mariel Metcalfe and Mark Hollis, Research PartnershipRecorded: Mar 21 201952 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
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 .
Dr Claire Irvine (HGF Ltd), Sarah Morgan (Life Sciences IP Review)Recorded: Mar 12 201965 mins
CRISPR gene-editing continues to hit the headlines regularly as a ground-breaking technology with many millions now flowing into companies seeking to exploit the technology in both the therapeutic and agricultural fields. Unfortunately, the IP landscape continues to lack clarity with possibility of divergence between Europe and the US.
This webinar is aimed at those wishing to hear about the latest developments in the CRISPR IP landscape whether in the commercial, academic, legal or patent world. With the CRISPR IP saga seemingly not close to the final chapter, it will also provide an opportunity to raise questions which may arise from the on–going lack of clarity.
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 (
Professor Antonio Bertoletti, M.D. Program in Emerging Infectious Diseases, Duke-NUS Medical School, SingaporeApr 25 20192:00 amUTC75 mins
Adoptive transfer of lymphocytes expressing engineered T cell receptors (TCRs) is a promising immunotherapeutic option which specifically targets antigens from viral-infected cells and tumors. Prof. Bertoletti and his team engineered a library of TCRs specific for different Hepatitis B Virus (HBV) antigens to generate a pool of HBV-specific TCR-T cells. These TCR-T cells have been shown to recognize HBV epitopes presented on infected hepatocytes and hepatocellular carcinoma (HCC) cells with HBV-DNA integration in both experimental models and selected patients with HBV-related HCC relapses. However, safety concerns on possible irreversible structural and functional liver damage by cytotoxic TCR-T cells have limited the clinical usage of this immunotherapeutic approach. To overcome this limitation, they selected patients with HCC relapses after liver transplantation for immunotherapy since TCR-T cells only target HBV epitopes presented on HCC-relapses. Moreover, they also modified TCR-T cell production methods to reduce cytotoxicity and life span of TCR-T cell. These strategies that lead to the successful production of safe TCR-T cell effectors for immunotherapy of HBV infection and HBV-related cancers will be discussed in this webinar.
John Jolliffe, Strategic Engagement, Adobe Document Cloud.Apr 25 20191:00 pmUTC45 mins
When it comes to conducting business with paperless documents, organisations have embraced electronic and digital signatures. The Electronic Identification and Trust Services Regulation (eIDAS) clarifies and simplifies the legal framework for e-signatures across Europe, but how should organisations decide which type of e-signature is appropriate to their needs? And how are new technologies helping to make electronic signatures relevant for the multi-device, highly mobile workspace of today?
Join our webinar, to learn:
• Why e-signatures are essential to your company's success now and in the future.
• Which three signature types are legal under eIDAS.
• How to select the right approach for your business.
• Next-gen e-Signatures and The Cloud Signature Consortium.
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.
Within this 45m webinar, you will gain insights from Natalie Cain, Senior Scientific Editor from Cell Press, on the publishing topics Ethics and Copyright. Learn about authoring responsibilities, post-publication issues, and strategies for publishing in high-standard and high-impact journals. Dr. Cain will also introduce you to Cell Press Mentor, a new service for scientists. Through the Egyptian Knowledge Bank (EKB,) all Egypt-based researchers and students have access to the Cell Press portfolio of scientific journals. Join us and discover the resources of Cell Press.
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.
Tony Kratovil, Salesforce; Miguel Tam, PropelMay 7 20194:30 pmUTC60 mins
As the world’s #1 customer success platform, Salesforce has helped thousands of manufacturers transform sales, service and marketing. But there’s more ways the Salesforce cloud platform can help manufacturing companies with their digital transformation.
For the highly customer-focused Engineer to Order business, the Salesforce platform can uniquely help sales, engineering and operations work better together on changing customer requirements, product designs, tooling estimates and supplier updates to deliver more winning and profitable bids.
Join this webinar with Salesforce and Propel, a Salesforce manufacturing software provider, to learn how companies are already improving their Engineer to Order processes and increasing product throughput by 500%.
Tony Kratovil, VP Manufacturing Solutions at Salesforce, and Miguel Tam, VP Alliances at Propel, will share how Salesforce and Propel are helping different teams collaborate directly with customers on everything from due dates, bills of materials, manufacturer parts and more.
In this live webcast learn the following and more:
=> How Salesforce solutions help Engineer to Order manufacturers track customer requests, product designs, files, and cost estimates
=> Real-world manufacturing examples that have increased customer retention, engineering throughput and operational efficiency
=> A live demonstration of how Propel and Salesforce uniquely support modern Engineer to Order business processes
Ekta Mahajan, Genentech/Roche and Dr. Saskia Haehn, Laboratory Manager for E & L at Merck KGaA, Darmstadt GermanyMay 8 20192:00 pmUTC75 mins
Presented by Ekta Mahajan, Technical Regulatory Program Director at Genentech
Extractables and their perceived impact on product and patients continue to be a challenge. The challenge is augmented by the lack of standardized extractable data from suppliers. BioPhorum Operations Group (BPOG) developed a standardized protocol for generating extractable data that would meet user requirements. This paper will discuss case studies where data from a supplier using the BPOG protocol significantly reduced the time for implementation.
Followed by Standardized protocols for generating extractables data on Filtration and Single Use Systems – An analytical perspective
Presented by Dr. Saskia Haehn, Laboratory Manager for E & L at Central Analytics of Merck KGaA, Darmstadt Germany
The Biopharmaceutical industry has always been aware of the risk of using disposable technology such as filters and Single use systems in their processes despite their several unique advantages. The ability to control and mitigate the risk from extractables and leachables to a product and the patient safety highly depends on the availability of the complete extractables profile for these products. In the recent years, tremendous efforts have been made towards standardization of the Extractables test methodology both from the perspective of using the right extraction methods and the enhancement of analytical techniques. This discussion will focus on the challenges and advantages using the various model solvent streams in the standardized test methods and their relative comparison. In addition, the focus would also be on the unknowns arising from the analysis using such model solvent streams.
Marina Kirkitadze,Head of Process Support at Sanofi Pasteur and Bonnie Edwards, Product Manager at Protein SimpleMay 21 20192:00 pmUTC75 mins
Presented by Marina Kirkitadze, Head of Process Support & PAT Platform, Analytical Sciences at Sanofi Pasteur
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.
Followed by Characterizing Sub-Visible Particle Populations with Micro-Flow Imaging
Presented by Bonnie Edwards, Product Manager of Imaging and MFI at ProteinSimple
Accurate determination of sub-visible particles and protein aggregates is important to ensure safety and efficacy of biopharmaceutical formulations. As such, biopharmaceutical manufacturers are expected to characterize, monitor, and control sub-visible particles and protein aggregates in their products. Traditional techniques such as light obscuration often lack the sensitivity to distinguish translucent and potentially harmful protein aggregates. With imaging-based, direct particle detection, Micro-Flow Imaging (MFI) offers several advantages over traditional techniques, enabling the ability to detect and identify protein aggregates as well as other sub-visible contaminants. In this presentation, we will discuss how MFI provides particle count, size, and other morphological information in order to provide novel and unique insights into particle characterization and quantification in protein formulations.
Dr. Frank Michel, Analytical & Chromatography Scientific Advisor, Merck KGaA, Darmstadt GermanyMay 22 20196:00 amUTC75 mins
Solid Phase Microextraction (SPME) is an invaluable tool for sample preparation in Environmental Analysis, because it is a trace analysis technology that is easy to fully automate. SPME is method of choice in many official analytical methods In Environmental Testing. This webinar provides an introduction into SPME and showcases how SPME facilitates different environmental applications for water testing.
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.
Routine and special stains are usually selected to demonstrate a special structure, chemical or molecular characteristic of the tissue. They are the first tool in a pathologist’s arsenal in detecting cancer in a patient's tissue. If there still are questions, a pathologist will request more advanced staining. This workshop will look at the more commonly requested special stains, and we will review the methods, application and results of these stains. We will also look at the complimentary IHC stains and how they compare.
Dr. Michael J. Miller, President of Microbiology, LLC and Lori Daane Pharma Microbiology Scientific Director at bioMérieuxMay 23 20192:00 pmUTC75 mins
Full Title: Regulatory Strategies and Case Studies for Rapid Sterility Testing of Gene and Cell Therapy Products
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.
Mark Plavsic, Chief Technology Officer at Lysogene & Archie Lovatt, Life Sciences Biosafety Scientific Director at SGSMay 24 20192:00 pmUTC75 mins
Together with product efficacy, product safety is an essential characteristic of any medicinal product including cell and gene therapy (C>) biologics. Adventitious agents (viruses, bacteria, mycoplasma, prions, etc) pose constant risk to these biologics, and, as such they may impact directly product and patient safety. It is therefore of supreme importance to intentionally (by design) employ effective measures across the whole C> product manufacturing process to mitigate risk of adventitious agents. This presentation will review various interconnected steps throughout the manufacturing process, from the raw materials to the fill and finish, that would, in concert, help mitigate the risk while providing a high degree of product safety by design.
Giustino Di Pretoro, of Johnson and Johnson and Dr. Robin Meier of L.B. Bohle MaschinenMay 28 20198:00 amUTC75 mins
- What is Drug Product Continuous Manufacturing?
- Is Continuous Manufacturing really worth the effort? "without data, you are just another person with an opinion"
- What are the challenges implementing CM?
- Development and tech transfer considerations for CM.
Demonstrate finacial and operational benefits of Continuous Manufacturing
Explain the key challenges in the implementation of CM in R&D
Explore key strategies in drug product development of CM
Bastiaan Leewis of MeiraGTx and Ankita Desai of EppendorfMay 29 20192:00 pmUTC75 mins
Full Title: Implementation Of An Affordable And Scalable Manufacturing Strategy For Gene Therapy Products
Presented by Bastiaan Leewis, MSAT Manager of Industrialization at MeiraGTx
As a start up with multiple clinical programs within an accelerated track we started designing our processes and aimed to build facilities to ensure therapeutic drug products reach patients as quickly as possible. As scientists and as people this tends to be the main goal, and although there are many challenges to commercializing a therapeutic drug product this is only the first step. To be able to continually serve patients, the company must be set up in a way to be sustainable throughout the clinical phase until revenue can be generated via commercial sales. Understanding the patient and company needs are a key cornerstone for having successful products and a successful company transition from clinical to commercial products. Within this presentation I will illustrate and explain the approach chosen by MeiraGTx for some of the platform components.
Followed by Bioprocess solutions for upstream bioprocess development and scale-up
Presented by Ankita Desai, Bioprocess Field Application Specialist at Eppendorf
Upstream bioprocess development is an integral part of gene therapy product development. Cell culture bioprocess development is usually carried out at small working volumes. This helps save time and resources, because several experiments can be conducted in parallel, costs for media are kept low, and relatively little laboratory space is required. When more material is needed for characterization, trial runs, and finally for commercialization, biopharmaceutical companies transition the process to bench scale and then up to pilot or production scale. In this presentation, we will present bioprocess solutions for parallel process development at small scale. Furthermore, we will discuss bioreactor scalability and address several scaling approaches.
Biomagnetic separation has proven to be a quick, efficient and clean process in Life Sciences. However, most researchers and developers focus only on the magnetic beads or particles to optimize their separation process. The effectivity of the biomagnetic separation depending on the magnetic carrier is only half of the story. To have the complete picture we also need to pay attention to the role of the applied magnetic field on the play. Not understanding or controlling the parameters linked to the magnetic separator will result in failure when developing new applications, and also in industrializing lab-scale developments. The webinar will review the basic concepts of magnetic separation and help the attendees understand how advanced systems may enlight key aspects of the process. These concepts will be applied to parameterize, monitor and validate the magnetic beads behavior in controlled conditions. Afterwards, the discussion will focus on how to transfer the correctly characterized biomagnetic separation process from laboratory to production scale. Finally, the webinar will address how to use this knowledge to assure the quality of the magnetic-carriers based products.
Alexia Lafarge and Adele GisselmanJun 6 20198:00 amUTC75 mins
Evolutions des référentiels qualité et crises sanitaires, comment le nettoyage et la désinfection apportent des réponses aux changements majeurs.
Nous présenterons les solutions de contrôle rapide du nettoyage allant des méthodes conventionnelles microbiologiques aux méthodes rapides en passant par le contrôle de l’air.
Dennis Douroumis, Professor in Pharmaceutical Technology and Process Engineering at University of GreenwichJun 11 20192:00 pmUTC75 mins
Hot Melt Extrusion (HME) is an established processing technology that can be used for the development of paediatric formulations. The processing of lipids via HME has been proved ideal for high drug loaded dosage forms with sustained release of drugs. The study investigates the effect of the lipid type and the food grade on the dissolution rates of extruded pellets or extemporaneous formulations. The stability of lipidic formulations is a very important aspect especially for paediatric applications. Here the stability of various formulations comprising of GRAS excipients is also examined.
Ravi Kalyanaraman and Jeremy Peters of BMS and Robert Heintz of Thermo Fisher ScientificJun 14 20192:00 pmUTC75 mins
Pharmaceutical Investigations and Technology (PIT) is a group within Global Analytical Technology (GAT) department in the commercial Quality organization within Bristol-Myers Squibb. The PIT group has been a key part in BMS for 30 + years in providing analytical support for commercial manufacturing and in pharmaceutical forensics. This include particulate and foreign matter characterization in pharmaceutical products and screening counterfeit drugs. Several analytical tools and techniques are used by PIT to support the pharmaceutical forensics. These include Energy Dispersive X-ray spectroscopy (EDS/EDX), Scanning Electron Microscopy (SEM), microscopes, Raman, Infrared (IR) and Near Infrared (NIR) micro-spectroscopy. Energy Dispersive X-Ray spectroscopy (EDS/EDX) is a powerful tool in the evaluation of foreign and particulate matter from a variety of processes and products. Coupled with an SEM, the technique provides a qualitative analysis of the elemental composition of particulate matter on the micron size range. The data from EDS can also be used for semi-quantitative applications when certain analytical criteria are met. Confocal Raman and NIR chemical imaging can successfully determine the chemical composition of the unwanted particulate foreign matter in finished pharmaceutical drug products. A point-by-point mapping technique along with CLS (Classical Least Square) fitting can be used to acquire a Raman chemical map of foreign particle surface and to identify the chemical components. In addition, both Raman and NIR spectroscopy have been widely used to rapidly screen counterfeit drugs. This talk will feature all the analytical techniques used by PIT and how the results are used in resolving manufacturing issues and to protect patients from counterfeit drugs.