Characterization of Subvisible Particles in Protein and Viral Vaccines
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.
RecordedMay 21 201953 mins
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Full Title: Crystallization Monitoring of Active Pharmaceutical Ingredient By Raman Spectroscopy
Presented by John-David McElderry, Scientist at Biogen
Crystallization of active pharmaceutical ingredients (API) as a process of purification, final crystal form selection, and/or particle size control is an important step in pharmaceutical manufacturing processes. Some crystallizations exhibit high degrees of complexity, making process development optimization and control challenging. In this study, Raman spectroscopy was utilized to monitor in real-time the polymorph form transition (Polymorphic form change: A → B → C) of an API in development at Biogen. Using polymorph reference materials, a multivariate approach was developed to identify the in-situ crystalline form of the API during the crystallization. The process started by dissolving API in dichloromethane in a jacketed lab reactor. A distillation was then performed to reduce the water content. Then a constant-volume distillation was implemented removing dichloromethane while iso-propanol was added (Polymorphic form nucleation of A). After all the dichloromethane was removed, seeds of the target form (C) were added and the mixture was held overnight. The real-time identification approach was capable of detecting the final form change (A → B → C or A → C).
Full Title: MES –Integrating Technology, Quality and Compliance – Opportunities, Challenges and Strategies.
Defining the role of MES in using technology to achieve compliance.
Addressing challenges in implementation of MES in current scenario with focus on Indian companies.
Technology taking the compliance and quality framework to the next level.
Organizational strategies to leverage the Power of technology by implementing MES.
Robert Dimitri, Associate Director, Digital and Data Sciences Lead at Takeda
A walkthrough of the journey towards Digital Transformation for Takeda's Massachusetts Biologics Operations Site. This presentation shares the journey towards enhancing the site's digital and analytics capabilities and bringing it closer to a digital world and the progress and processes taken thus far.
Presented by Robert Dimitri
Robert Dimitri is a Director in Takeda’s Business Excellence group for the Biologics Operating Unit as the Digital Transformation and Innovation Lead. Previously he led the Digital and Data Sciences group in Manufacturing Sciences at Takeda’s Massachusetts Biologics Site leading a team for the implementation of digital tools used for the analysis of internal manufacturing operations data, used to support the production of biologic drugs to treat rare diseases. He has over 15 years of experience in this field, having worked previously as a process engineer and developing software to perform process data analytics. Robert has a B.S. degree in Chemistry and Computer Science, an M.S. in Computer Science, and an M.B.A.
Ruth Daniels, Senior Scientist, Microbiology Expert, Janssen and Kevin Williams Microbiological Test Development, bioMérieux
Presented by Dr. Ruth Daniels, Senior Scientist - Microbiology Expert at Janssen
This webinar presentation will discuss:
• Endotoxin hold time studies to identify LER
• In silico assessment of interfering factors and associated LER mitigation strategies
• Case study: optimization of product-specific LAL assay to overcome LER
Followed By A Presentation From Kevin L. Williams, Microbiological Test Development at bioMérieux
Karen Zink McCullough, Owner, Principal Consultant at MMI Associates
Presented by Karen Zink McCullough, Owner, Principal Consultant at MMI Associates
The Bacterial Endotoxins Test is not a test for pyrogens (fever causing agents). It is not a test for the presence of Gram negative bacteria. Based on extensive comparisons of endotoxins activity in the BET and fever rabbits executed in the 1970s and 1980s, we may say that the BET is a test for levels of Gram negative bacterial endotoxins activity that may be predictive of a fever in mammals.
The various methodologies that are described in the harmonized in the harmonized chapter use the primary Reference Endotoxin Standard (RSE) or secondary Control Standard Endotoxin (CSE) to prepare assay standards, perform suitability testing as instructed in the chapter and inoculate positive product controls. These standards are relatively pure preparations of lipopolysaccharide. However, the utility of the compendial assay for non-compendial applications is limited. Our discussion will focus on the compendial uses of these BET assays.
Dr Friedrich von Wintzingerode, QC Lead iNeST Project (individualized Neoantigen Specific Therapy) at Roche
FULL TITLE: A Comprehensive Approach to Assess the Impact of Microbial Impurities on Patient Safety and Product Quality of Biologics
Presented by Dr Friedrich von Wintzingerode, QC Lead iNeST Project (individualized Neoantigen Specific Therapy) at Roche
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 Case-by-Case Assessment of Bioburden (CCAB) approach described here enables a comprehensive assessment of these risks.
Dr Christine P. Chan, Ph.D. Director in Global Manufacturing Science & Technology at Sanofi
Presented by Dr Christine P. Chan, Ph.D. Director in Global Manufacturing Science & Technology at Sanofi
Bioprocess changes can impact quality attributes of biologics and may affect efficacy and safety of the product. During development and throughout the product lifecycle, when process improvements are implemented, it is essential to gather sufficient data to support the conclusion that product safety and efficacy has not been adversely affected. This demonstration exercise requires careful planning of the comparability studies and is based on the background knowledge of protein structure, biological function, and clinical attribute profiles of the product accumulated during development.
In this webinar, I will discuss strategies and considerations for analytical characterization of protein structure and function which forms the foundation of the comparability demonstration.
Jincai Li, Vice President of WuXi Biologics, Kevin Mullen, Sr Product Manager, Single-Use Systems at Thermo Fisher Scientific
Presented by Dr. Jincai Li, Vice President of WuXi Biologics and Kevin Mullen, Sr. Product Manager, Single-Use Systems at Thermo Fisher Scientific
With the rapid growth of the biotherapeutics industry, the need and challenge for high quality cost efficient production have been increasing as well. At the same time, the number of approved biologics products are also steadily increasing, and more and more products are being developed by small to mid-size biotech companies, with product market size that varies greatly and therefore leading to varying production scale needs. The presentation will talk about the paradigm shifts in today’s facility design and operations, with the multi-purpose facility and smaller, the modular facility being favoured by many companies. In addition, rapid adoption of disposable technology has enabled faster and lower cost facility design & start-up. With the modular, disposable technologies, the unique “scale-out” approach has the advantage of providing the highest flexibility to customers while simultaneously lowering tech transfer and scale-up risks. The presentation will also cover the continuous bioprocessing concept and share WuXi’s efforts on this area
Presented by Dhaval Tapiawala, Principal Scientist at Pfizer
• Understanding extractables and leachables for better adoption of single use systems
• Ensuring safety of drug through determining the level of leachables throughout product life cycle
• Case Study of implementation of standardized testing protocol
Michelle Raikes, M.S., Scientist IV and Dr. Fredrik Nordstrom, Sr Research Fellow at Boehringer Ingelheim
Full Title: Quantification and Control of Amorphous contents by Raman, Application and Case Studies in Pharmaceutical Processing
Presented by Michelle Raikes, M.S., Scientist IV and Dr. Fredrik Nordstrom, Sr Research Fellow at Boehringer Ingelheim
Amorphous regions in crystalline material can have significant impact on bioavailability, processability and stability. Conversely, crystalline material can act as nuclei for recrystallization and resulting in instability of amorphous systems. Raman spectroscopy is sensitive to polymorphic differences and amorphous content in pharmaceutical materials. This make Raman spectroscopy a powerful process analytical technology (PAT), when combined with multivariate modelling, to control the amorphous content in a pharmaceutical process. We will present pharmaceutical case studies showing process-induced amorphization of crystalline drugs across the DS and DP processing steps. In addition, we will compare the kinetics of crystallization of amorphous material when stored at various relative humidity and temperature conditions. The results clearly demonstrate that Raman spectroscopic techniques combined with multivariate methods is a powerful and effective tool for quantitation of amorphous content in crystalline material with applications ranging from API isolation, milling and to multiple unit operations in DP manufacturing. The information generated was critical to determine the root-causes and outline appropriate mitigation measures
Lars Hovmand-Lyster, Senior Engineering Specialist in Novo Nordisk Global Project Office (GPO)
Presented by Lars Hovmand-Lyster, Senior Engineering Specialist in Novo Nordisk Global Project Office (GPO) Engineering Management Department
• Build the roadmap to biopharmaceutical manufacturing and their partners in developing, assessing and verifying unit operations leading to an appropriate facility design that is “right classified”
• Hear first-hand about this industry-developed document to understand the tools, steps and documents required to adequately risk assess and qualify modern facilities that make use of modular, closed technology
• Learn how following a methodology results in significant gains in reducing the time to deliver the facilities and CAPEX and OPEX costs
Dr. Michael J. Miller, President of Microbiology Consultants, LLC
EU Annex 1 is getting a tremendous makeover and significant revisions enabling the use of rapid methods and changing acceptance levels for environmental monitoring are forthcoming. In this webinar, Dr. Michael J. Miller will present an overview of regulatory and compendial policy changes that encourage the use of rapid methods for environmental monitoring, with a focus on the revision to Annex 1. This will be followed by an actual case study in the use of a real-time rapid method for the instantaneous and continuous detection of microorganisms in an isolator environment.
Ken Wong of Sanofi Pasteur, Desmond G. Hunt, of USP and James Hathcock of Pall Biotech
Utility of Generating Data: Drug Manufacture’s Perspective: Will USP permit such format?
Presented by Ken Wong, Desmond G. Hunt and James Hathcock
This talk will focus on an overall application of USP starting from risk assessment to qualification of disposable manufacturing systems based on USP data set. All the key principles with examples where these principles need to be satisfied before one can apply the USP data for disposable manufacturing system qualification will be discussed and illustrated. Lastly, different qualification approaches will also be presented to provide broader understanding.
Followed by a presentation by Desmond G. Hunt, Principal Liaison at United States Pharmacopeia
Dr. Desmond G. Hunt has been with USP since 2005 and holds the position of Principle Scientific Liaison in the Compendial Science Group-General Chapters. He is the scientific liaison to the Packaging and Distribution and Dosage Forms Expert Committees, where he works to develop and revise USP Standards. He has authored many publications and peer-reviewed articles and is a frequent speaker and instructor on topics related to pharmaceutical packaging, particulate matter in parenteral and ophthalmic dosage forms and good storage and transportation practices. He participates on several industry Working Groups and Technical Committees related to his areas of expertise. Dr. Hunt obtained his M.S. and Ph.D. from the University of Texas at Austin and prior to joining USP, was a Research Fellow at the National Institutes of Health, Bethesda, MD, USA
And Followed by an Industry Perspective presented by James Hathcock, PhD, Sr Director, Regulatory and Validation Strategy at Pall Biotech
Dr. Michael J. Miller, President of Microbiology Consultants, LLC
The implementation of rapid microbiological methods (RMM) has gained significant momentum over the past few years. In particular, the ATMP segment has a desire to release cell and gene therapies using rapid sterility tests to accommodate patient needs and very short drug product shelf life. Additional rapid sterility testing needs are now being fueled by companies who are developing vaccines for COVID-19 clinical trials.
In this webinar, Dr. Michael J. Miller will present an overview of past and future microbiological methods, the current regulatory landscape for rapid sterility testing including recent policy changes, applicable technologies and validation strategies.
Rajesh K. Gupta, Ph.D. Biologics Quality & Regulatory Consultants, LLC, North Potomac
Coronavirus disease (COVID-19) is a terrifying illness with high morbidity and mortality throughout the world and with devastating effects on businesses, economies, livelihood of individuals and producing depression/fear among populations due to prolonged lock downs. The only way to control the disease appears to be by developing herd immunity, either by infection or by universal vaccination. Achieving herd immunity by infection seems horrific with a significant burden on healthcare systems and sacrificing vulnerable population, including older people, and those with underlying medical problems like cardiovascular disease, diabetes, chronic respiratory disease, and cancer. Achieving herd immunity through vaccination will take at least several months to years after development of a safe and effective vaccine. Typically, it takes a decade or more to develop a vaccine. Scientists and vaccinologists from academia, industry and Government organizations are enthusiastically working on more than 100 vaccine candidates to develop a safe and effective vaccine. There are numerous scientific, technical, manufacturing, and regulatory challenges and risks in developing vaccines in general, particularly under a fast timeline. This Webinar will go over the challenges and risks in developing Coronavirus vaccines with a view to identifying these for resolution and mitigation along with development of the vaccines.
Francis Verhoeye, Global Pilot Operations Leader at Zoetis Inc. and Benjamin Asher Senior Product Manager – Bioproduction
FULL TITLE: Single-Use Bioprocess Platform for Veterinary Vaccine and Biopharmaceutical Pilot-Scale Production
Presented by Francis Verhoeye, Global Pilot Operations Leader at Zoetis Inc. and Benjamin Asher Senior Product Manager – Bioproduction
•Understand the implementation journey taken to accelerate veterinary biological product development
•Identify the challenges of integrating vaccine and biopharmaceutical processes
•Learn about the single use qualification and implementation process in a multi-product facility
Sara Ullsten R&D Section Manager, Cytiva and Haiyan Hong, R&D manager of Life Sciences at Saint-Gobain
This Webinar is a continuation of Final Revised Version of BioPhorum Extractable Testing Recommendation Part 1
Since the first publication of BioPhorum (previously known as BPOG) Extractable Testing Recommendation in 2014, the combined team of end-users and suppliers has collaborated to examine all improvement opportunities to the original Extractable Testing Recommendation since 2017. During this webinar, the presenters will highlight all the changes to the final revised version of BioPhorum Extractable Testing Recommendation. Specifically, the output of a data review of 26 extractable data sets spanning wide varieties of single use components, which has led to the changes to be made in the original recommendation, will be presented.
The revised extractable testing recommendation will be presented to highlight:
1) How to access the final version of the Biophorum Extractable Testing recommendation and example reporting template;
2) “Data Sharing Rules of the Road” recommendations for simplifying access to the reports
3 ) Where are the extractable data report flexibilities when using BEDS templates?
To facilitate a harmonized extractable data reporting to end users, the presenters will introduce the newly designed BioPhorum Extractable Data Summary (BEDS) template. Some levels of details with regards to what specific information or format of templates are compulsory and what are flexible for supplier to tailor to their own preferences will be detailed during the webinar. How end users can gain access to these extractable summary reports from suppliers, including subsuppliers, will be addressed.
Additionally, several FAQs questions will be presented to clarify some common questions. The webinars will end with 30 minutes of a panel discussion for participants to seek clarify of all presented information.
Dan Hill, Manufacturing Scientist at Biogen and Maryann Cuellar, Life Science Product Manager at Kaiser Optical Systems, Inc.
The use of in-line Raman spectroscopy as an in-line process analytical technology (PAT), in the biotechnology industry, has matured over the past decade from a technology with promise to a standard tool for real-time, continuous monitoring of cell culture processes. There is an ever-growing body of work demonstrating successful application from metabolite and product quality monitoring to process control in both process development and GMP manufacturing environments. This is due, in part, to advances in technology robustness, user- and integration-interfaces, improved sensitivity, and fluorescence rejection. Organizations are now faced with the difficult task of best leveraging these tools and extracting the most value from them. Thus, defining and executing Raman program strategy is critical to the technology’s long-term success and sustainability.
This presentation will describe Biogen’s past efforts and strategic direction as it relates to in-line Raman spectroscopy for cell culture operations and how we intend to leverage its capability beyond metabolite monitoring and glucose feedback control to become an essential element of our Advanced Process Control efforts.
The Journal for Asia's Pharmaceutical and Biopharmaceutical Industry
BioPharma Asia aims to keep its 30,000 readers abreast of all developments in the areas of Drug Development, Drug Delivery, Manufacturing, Quality Assurance, Outsourcing and Regulatory Affairs, with only the highest quality articles, written by the most respected authors, associated with only end-user companies. This ensures that the information will always be guaranteed to remain timely, informative and above all totally unbiased.
Characterization of Subvisible Particles in Protein and Viral VaccinesMarina Kirkitadze,Head of Process Support at Sanofi Pasteur and Bonnie Edwards, Product Manager at Protein Simple[[ webcastStartDate * 1000 | amDateFormat: 'MMM D YYYY h:mm a' ]]53 mins