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Modernizing Biopharmaceutical Manufacturing: From Batch to Continuous Production

The importance and value of continuous bioprocessing, both upstream and downstream has economic and sustainability advantages and due to the modular nature of continuous bioprocesses means that industry is able to adapt more rapidly to changing market demands. Continuous biopharmaceutical manufacturing in the context of other industries that have already successfully adopted continuous processing. Factor other than scientific ones, are the barriers to change from batch to continuous production. an excellent example of the manufacturing strategies of the steel industry in the 20th century, when this industrial sector incrementally switched from batch to continuous operations. biopharmaceutical industry has reached a stage that requires a change in the production paradigm. For a certain class of biopharmaceutical products upstream continuous manufacturing has always been applied: for example, unstable proteins that rapidly degrade in the culture broth. In order to obtain a high quality product, the residence time in the reactor must be minimized. This can only be achieved with continuous cultivation and preferably with perfusion reactors. a brief overview on the types of cell retention devices currently used in biopharmaceutical industry.
Furthermore, this is a universal production platform that can be extended to other classes of products, such as antibodies, which are relatively stable molecules. continuous manufacturing is as productive and with a much smaller footprint of the manufacturing plant, avoiding multiple non-value added unit operations. In essence, the investment for a continuous plant is much smaller compared to a batch-operated one.
Recorded Jul 19 2017 66 mins
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Presented by
Dr Robert Dream & Dr Peter Levison
Presentation preview: Modernizing Biopharmaceutical Manufacturing: From Batch to Continuous Production
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  • Current Bacterial Endotoxins Test (BET) and its Intended Use Sep 24 2020 2:00 pm UTC 90 mins
    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.
  • A Comprehensive Approach to Assess the Impact of Microbial Impurities on Pat... Sep 16 2020 5:30 pm UTC 90 mins
    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.
  • Analytical Strategies for Comparability in Bioprocess Development Sep 15 2020 2:00 pm UTC 90 mins
    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.
  • From Concept to Market – Unique Approaches in Biomanufacturing Sep 11 2020 7:00 am UTC 90 mins
    Jincai Li, Vice President of WuXi Biologics
    Presented by Dr. Jincai Li, Vice President of WuXi Biologics

    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
  • Extractables and Leachables Testing Using a Quality Risk Management Approach Sep 9 2020 2:00 pm UTC 90 mins
    Dhaval Tapiawala, Principal Scientist at Pfizer
    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
  • Global Sterile Transportation and Formulation of an Adjuvant Sep 8 2020 8:00 am UTC 90 mins
    Charlotte Masy, Project Manager at GSK vaccinés and Donald Young, Sr. Product Manager at Thermo Fisher Scientific
    Presented by Charlotte Masy, Project Manager in global support GSK vaccinés

    Followed by an Industry Perspective presented by Donald Young, Sr. Product Manager at Thermo Fisher Scientific

    • Understand how to develop a solution for global use
    • Uncover the challenge of sterile product transportation (E&L)
    • Discuss the pros and cons of single use solutions in this type of application
  • Quantification and Control of Amorphous contents by Raman, Application and Case Sep 4 2020 2:00 pm UTC 90 mins
    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
  • Fully Utilizing Closed Systems in Modern BioPharma Facilities Sep 3 2020 2:00 pm UTC 90 mins
    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
  • Rapid Microbial Methods - Reap Benefits And Avoiding Pitfalls Jul 13 2020 2:00 pm UTC 90 mins
    Andrew Bartko, Research Leader at Battelle Memorial Institute
    An overview of the design, validation and implementation of RMM.
    Regulatory advice for RMM implementation
    3 key takeaways from a case study of RMM implementation
  • Utility of Generating Data: Drug Manufacture’s Perspective: Will USP... Jun 23 2020 2:00 pm UTC 90 mins
    Ken Wong of Sanofi Pasteur, Desmond G. Hunt, of USP and James Hathcock of Pall Biotech
    Full Title:Utility of Generating Data: Drug Manufacture’s Perspective: Will USP permit such format?

    Presented by Ken Wong, Deputy Director at Sanofi Pasteur

    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
  • Single-Use Bioprocess Platform for Veterinary Vaccine and Biopharmaceutical Pi.. Jun 11 2020 8:00 am UTC 90 mins
    Francis Verhoeye, Global Pilot Operations Leader at Zoetis Inc.
    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.

    •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
  • Advanced Raman Spectroscopy Beyond In-Process Glucose Control of Commercial Cell Jun 3 2020 2:00 pm UTC 90 mins
    Dan Hill, Manufacturing Scientist at Biogen
    Full Title:Advanced Raman Spectroscopy Beyond In-Process Glucose Control of Commercial Cell Culture Processes

    Presented by Dan Hill, Manufacturing Scientist at Biogen

    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.
  • Next Frontier in Subvisible Particle Analysis: New Tools and Opportunities May 21 2020 5:00 pm UTC 90 mins
    Danny Chou, President and Founder at Compassion BioSolution, and Mark Bumiller, Technology Manager at Particle Sizing Systems
    Presented by Danny Chou, President and Founder at Compassion BioSolution, LLC
    Followed by an industry perspective presented by Mark Bumiller, Technology Manager at Particle Sizing Systems, an Entegris Company

    In the past decade, we have witnessed the arrival of a large number of analytical technologies that are useful for characterizing sub-visible particles in protein therapeutics. Even with the diverse tools that are available today, there are still important gaps that have not been filled but yet have a significant role in our ability to fully analyze particles for either product characterization or formulation development purpose. The goal of this presentation is to highlight some of these gaps and share the opportunities that may be captured by new tools that are on the horizon. Finally, the speaker will elaborate on how simultaneous monitoring of sub-micron and micron-sized particles can assist biopharmaceutical formulation development and help fulfill current and future regulatory requirements.”
  • Continuous Manufacturing as a Default Platform for Oral Solid Drug Products May 19 2020 8:00 am UTC 90 mins
    Lawrence De Belder, Senior Principal Engineer at j&J and Bob Lenich, Director of Life Sciences Business at Emerson
    Presented by Lawrence De Belder, Senior Principal Engineer Continuous Manufacturing at Johnson and Johnson

    Followed by an Industry Perspective presented by Bob Lenich, Director of Life Sciences Business at Emerson

    The counter is at Six today: Orkambi, Symdeko, Trikafta (Vertex); Prezista (Johnson and Johnson); Verzenio (Eli Lilly); Daurismo (Pfizer) –are all approved by the FDA – Johnson and Johnson’s Tramacet for the Japanese market not included. Several large Pharma companies have chosen the path of Continuous Manufacturing, and announced they will use this platform as their default for development and consequently – commercial manufacturing of their Oral Solid dose drug product pipeline.

    During this webinar, the author will explain the consequences of this decision, and different strategies to handle a pipeline that can be highly dynamic. Different techniques will be discussed that can be used to bring products with bad flow properties into a continuous process. Impact of different equipment in development, clinical and commercial environment will be detailed out, and mitigations will be proposed to overcome these differences. All will be placed in front of a background of regulatory requirements, changing market demand, and evolving strategies of equipment vendors.
  • Assessing the Risk of Interaction Between Extractables and Leachable and Ther... May 14 2020 2:00 pm UTC 90 mins
    Andrew Teasdale, Senior Principal Scientist at AstraZeneca and Piet Christieans, Phd,Scientific Director at Nelson Labs
    FULL TITLE: Assessing the Risk of Interaction Between Extractables and Leachable and Therapeutic Proteins

    Presented by Andrew Teasdale, Senior Principal Scientist Impurity management and External Advocacy at AstraZeneca

    Biologics and Peptides often present their own challenges in respect to leachables. They are typically administered parenterally and therefore there is a high risk of interaction between dosage form and packaging / administration system. They are often low dose and sensitive to structural modifications, this can impact Safety (immunogenicity), Quality (instability, aggregation) and Efficacy (loss of potency). This webinar will examine the potential risk factors through case study examples including reactive leachables, the impact of sterilisation and adverse events and their route cause. It will conclude by looking at opportunities to look predictively at potential issues and how this can be incorporated into product design

    Followed by Piet Christieans, Phd,Scientific Director at Nelson Labs
  • Affinity Chromatography for Vaccines Purification May 12 2020 2:00 pm UTC 90 mins
    Mikkel Nissum, Vaccine R&D Quality Site Lead at GSK Vaccines
    Presented by Mikkel Nissum, Vaccine R&D Quality Site Lead at GSK Vaccines

    Only clean drinking water rivals vaccination in its ability to save lives. Yet, development and manufacturing of vaccines remain challenging. Vaccines comprise a heterogeneous variety of targets. Each target requires a dedicated development and manufacturing process adding to the timelines for getting new vaccines to the patient and to ensure a reliable supply. For the downstream processing part, often the process is composed of an optimized set of up to three chromatographic steps to provide the final desired quality of the target. On top of the long development time required to develop such a multi-step process, at times, the end result may not be satisfactory, in particular regarding purity of the target.
    In order to overcome this downstream processing challenge, we embarked on establishing a purification platform based on affinity purification. The main advantages of such a platform for vaccine manufacturing would be:
    1)By applying a positive selection principle for chromatography, the number of chromatographic steps may be reduced to just one step
    2)Establishing a platform would require minimal process changes from one target to another
    3)Downstream processing would become predicable in terms of development time and costs
    The journey of establishing the affinity purification platform focusing on main challenges and key results will be presented in the Webinar.
  • Machine Learning in Bioprocess Development: Where We Are and Where We Could Go May 6 2020 2:00 pm UTC 90 mins
    Moritz von Stosch, PhD, Senior Manager, Technical R&D, GlaxoSmithKline Vaccines
    Machine Learning is believed to be a game changer for industry, especially by big Pharma as reflected by significant investments. Starting from an introduction to machine learning, this contribution outlines the current machine learning status for process development with examples, provides future directions towards more global high-value machine learning centric development, concepts to engage people in the digital evolution and ideas for machine learning centric business models.

    Presented by Moritz von Stosch, PhD, Senior Manager, Technical R&D, GlaxoSmithKline Vaccines

    Moritz von Stosch works as Senior Manager at Technical R&D of GSK Biologicals, Belgium. He is a process systems engineer by education with a Diplom in Chemical Engineering from the RWTH-Aachen University and PhD in Biochemical Engineering from the University of Porto. Before joining GSK, Moritz worked as a Lecturer at the School of Chemical Engineering and Advanced Materials at Newcastle University, where his research focused on the development of novel hybrid modeling methods and their application to enable more efficient process operation/design.
  • New Drying Processes for Biopharmaceuticals May 5 2020 2:00 pm UTC 90 mins
    Sune Klint Andersen, Principal Scientist at Janssen Pharmaceutical Companies of Johnson & Johnson
    Presented by Sune Klint Andersen, Principal Scientist at Janssen Pharmaceutical Companies of Johnson & Johnson

    Sune Klint Andersen is Principal Scientist for Spray Drying at the Janssen Pharmaceutical Companies of Johnson & Johnson. He has a Ph.D. in Chemical Engineering. He has worked with pharmaceutical spray drying for 17 years within process development for R&D and commercial scale, application of Quality-by-Design and PAT, particle engineering, drying kinetics, aseptic spray drying and advantages and disadvantages of spray vs freeze drying processes. He previously worked at Novo Nordisk for 7 years.
  • Transformation of Toxicology data into Specific PDE’s Apr 23 2020 5:00 pm UTC 90 mins
    Kim Li, PhD, DABT, MPH, Amgen Inc and Dries Cardoen, Team Leader of Study Directors at Nelson Laboratories, LLC
    Presented by Kim Li, PhD, DABT, MPH, Amgen Inc.

    Followed by an industry perspective presented by Dries Cardoen, Team Leader of Study Directors - Inhalation/topical/transdermal products at Nelson Laboratories, LLC

    Permitted Daily Exposure (PDE) has origin in ICH Q3C: Impurities – Guideline for Residual Solvents. This webinar will discuss the principles and methods of applying PDEs to extractactables and leachables (E&L) impurities in pharmaceutical products. We will review the regulatory advice on the DO’s and DON’Ts. Then we will review the current toxicology risk assessment practice on data gathering, literature synthesis and selection of the critical studies with robust toxicity endpoints. We will show how the toxicity endpoints are transformed into chemical-specific PDE values with modifying factors. We will highlight the importance of clinical relevance to further refine the PDE values. For a case study, we will share an extraction study of a polyolefin bag for use with a lyophilized product. We will examine the risk matrix per USP Assessment of drug product leachables associated with pharmaceutical packaging/delivery systems. The toxicology assessment of the extractables profile of the bag will illustrate the derivation of chemical-specific PDEs, as well as the refinement by taking clinical relevance into consideration.
  • New Technologies for Improving and Controlling Product Quality, Expression, Time Apr 7 2020 6:00 am UTC 90 mins
    Niki Wong, Principal Research Scientist at AbbVie Operations Singapore Pte Ltd
    Full Title: New Technologies for Improving and Controlling Product Quality, Expression, Timelines and Yield in Upstream Process Development

    Presented by Niki Wong, Principal Research Scientist at AbbVie Operations Singapore Pte Ltd

    Increasing product demands at competitive pricing drive the need for accelerated product approval timelines, with reduced manufacturing risks and costs. New technologies which can debottleneck upstream process development or improve manufacturability success in early phase process development, translate into cell culture processes with high yield and desired product quality. An overview of different strategies and recent perspectives in upstream process development will be presented.
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  • Live at: Jul 19 2017 2:00 pm
  • Presented by: Dr Robert Dream & Dr Peter Levison
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