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Novel Technologies That Aid the Detection and Differentiation of Proteinaceous..

Full Title: Novel Technologies That Aid the Detection and Differentiation of Proteinaceous Impurities in Biologic Drug Substances and Drug Product

Presented by Danny Chou, President and Founder at Compassion BioSolution, LLC

The goal of this presentation is to share recent developments in analytical approaches to detect, quantify and differentiate impurities in biologics that are the result of protein-container, interaction and aggregation
Recorded Nov 30 2020 87 mins
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Presented by
Danny Chou, President and Founder at Compassion BioSolution, LLC
Presentation preview: Novel Technologies That Aid the Detection and Differentiation of Proteinaceous..
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  • Analytical Techniques in Extractable and Leachables May 20 2021 2:00 pm UTC 120 mins
    Dr. Tom van Wijk, Abbott Healthcare Products BV
    In contrast to other impurities the control of extractable and leachables is not well defined yet. Currently guidance is provided e.g. by USP and PQRI, but there is room for interpretation. New guidance (ICHQ3E) is being developed. In general, comprehensive screening is applied, using gas- and liquid chromatography techniques hyphenated with mass spectrometry, to aim for complete coverage on E&L. Although considered to be the state-of-the -art approach, in practice this approach is not as straightforward as it may seem. Many assumptions are made and for effective approach an E&L database is deemed necessary. Moreover, the strategy is completely opposite compared to the strategy applied for potential mutagenic impurities which is highly relying on a theoretical assessment (Risk based approach). The presentation will focus on the analytical technique selection, challenges of coverage of E&L in the current strategy and finally a perspective on E&L analysis.
  • Mycoplasma Testing: Past, Current, and Future State Apr 29 2021 5:00 pm UTC 120 mins
    Kenneth Tai, Quality Control Scientist, Global Analytical Science Technology at Genentech
    For nearly 30 years, mycoplasma testing for biologics have been performed using cell culture-based methods.  The compendial mycoplasma detection method has been the gold standard in the biopharma industry.  Its high sensitivity (0.1 CFU/mL detection) is achieved through multiple subcultures and observations of culture media and agar plates over the course of 28 days.  While awaiting for the results of testing, CHO-derived antibody drug substances are stored in freezers; however, long storage times have contributed to an inefficient supply chain network resulting in huge costs.    

    Pressure to reduce long turnaround times (TAT) has spurred innovation through the use of nucleic acid technologies (NAT), such as real-time PCR.  With guidance from the European pharmacopeia chapter (2.6.7), multiple biopharmaceutical companies have successfully validated real time PCR methods for testing.  In addition to the benefit of reducing TAT from 28 days to a single day, cost to the patients are reduced from lowering FTE, reducing storage costs, and creating a more agile supply chain network. 

    TAT reduction becomes even more critical in the new cell and gene therapy landscape, where some of these medicinal products are customized from the patients themselves.  Furthermore, integration of testing built into the production line can improve efficiency and further expedite live saving medicines.  As innovate therapies emerge, quality control tests must also become creative to adapt to these new modalities.  That includes mycoplasma testing.
  • Risk Assessment of Extractables and Leachables... Apr 22 2021 2:00 pm UTC 120 mins
    Presented by Dr Clemens Günther, Senior Expert Nonclinical Safety, Director at Bayer AG, R&D Pharmaceuticals
    Full title: Risk Assessment of Extractables and Leachables in Different Phases of Development.

    As the knowledge on the manufacturing process evolves during the development of a drug product or medical device, it is advised to include learning cycles into the development program to avoid existence of critical E&Ls. These learning cycles offer the opportunity to increase the knowledge on E&L associated with the product over its development time. Initially, chemical information should be collected on the materials used. First extraction studies will guide concerns, followed by simulation studies which are designed to mimic reality. At the end, the leachable study has to meet regulatory requirements and must cover real use conditions until end of product shelf-life, and these leachables need to be covered by a thorough toxicological risk assessment.
  • The Common Road to Quality for Single Use Materials Apr 21 2021 5:00 pm UTC 120 mins
    Trishna Ray-Chaudhuri, at Roche Group, Kevin Mullen at Thermo Fisher and Marcus Bayer at Hamilton Company
    Single use system (SUS) quality needs are similar to requirements used for their stainless steels analogs.  As an example, a user implementing a stainless-steel system must oversee the design completely and is responsible for process validation.   Similarly, when a user retrofits a stainless-steel system, the user and SUS supplier partner to demonstrate equivalent levels of quality and process control.  The supplier is responsible for manufacture, cleanliness and sterilization while the end-user remains accountable to the regulatory agency for the quality of the process and final drug product.

    This webinar will review the current best practices for implementation of single use systems with regard to quality, specifications, and user requirements.  The content was created in partnership with companies and suppliers across the industry and represents the current perspectives for best practices.
  • Mechanistic Modeling in Early Stage Chromatography Process Development... Apr 19 2021 5:00 pm UTC 120 mins
    Yuyi Shen, Associate Director, Process Development and Manufacturing at Bolt Therapeutics
    Full Title: Mechanistic Modeling in Early Stage Chromatography Process Development for Improving Process Efficiency and Productivity

    This webinar provides an overview of current process innovation challenges and needs. The presenter identified that computational mechanistic modelling can be used to simulate chromatographic process performance and process optimization. Various case studies, applications and lesson learned from modeling will be shared by the presenter. The webinar concludes a comparative analysis between empirical and mechanistic modeling and provide the insights of balance needs for both approaches.
  • Microbiological Attributes, Specifications and Risk Assessment... Mar 24 2021 2:00 pm UTC 120 mins
    Tony Cundell, PHD. Principal Consultant, Microbiological Consulting, LLC,
    Full Title: Microbiological Attributes, Specifications and Risk Assessment of Culture-based Therapeutic Products

    A major challenge with emerging heterogeneous, live culture-based products is setting consistent, risk-based microbial specifications to protect the recipients of these product from potential microbial infection. A review of the literature and the published regulatory requirements demonstrates a lack of consensus as to donor and/or product infectious disease screening that may inevitably harm patients along with increased costs and delayed product availability. This presentation addresses the microbiological attributes, specifications, screening methods, and risk assessment of these unique products that contain live microbiological cultures, include probiotics, fecal microbiota transplantations, fecal-derived consortium cultures and therapeutic bacteriophage products and makes recommendations as to the path forward.
  • ICH Q3E Guidelines and It's Implications Mar 22 2021 9:00 am UTC 120 mins
    Andrew Teasdale at AstraZeneca and Dries Cardoen at Nelson Laboratories, LLC
    Andrew Teasdale, Senior Principal Scientist Impurity management and External Advocacy at AstraZeneca

    Andrew Teasdale is Chair of AstraZeneca impurities advisory group. Responsible for the development and oversight of policy relating to all impurity categories, including impurity qualification / genotoxic impurities / metals and extractables & leachables. Dr Teasdale is an expert within the field of Genotoxic Impurities as well as the editor of the first book specifically focused on the subject matter : Genotoxic Impurities: Strategies for Identification and Control. His current activities include leading a cross industry group in the development of an addendum table to ICH M7, including specific limits for genotoxic reagents (analogous to that in place in ICH Q3C for solvents). Inventor of the purge factor calculation concept used in the risk assessment of genotoxic impurities. He is currently the chair of the Extractables and leachables safety information exchange (ELSIE) materials group. He is also Chair of the Joint Pharmaceutical Analytical Group (JPAG). His expertise also within quality assurance and pharmaceutical analysis field. With extensive project management experience both internally and in relation to cross industry collaborations. With specialties in Evaluation and risk assessment of genotoxic impurities / metals and extractables and leachables. He has more than 15yrs experience as an analytical chemist and is Chairman of the Joint Pharmaceutical Analytical Group (JPAG).
  • Hybrid Models: The Best of Both (Mechanistic & Empirical) Worlds to Accelerate.. Mar 16 2021 2:00 pm UTC 120 mins
    Christian Airiau,Global Head Data Sciences at Sanofi and Chris McCready, Lead Data Scientist at Sartorius
    Full Title: Hybrid Models: The Best of Both (Mechanistic & Empirical) Worlds to Accelerate and De-Risk Process Development

    Presented by Christian Airiau, PhD, Global Head Data Sciences, Biologics Development at Sanofi and Chris McCready, Lead Data Scientist at Sartorius Stedim Biotech

    Process optimization through the use of modeling is a key objective to accelerate and de-risk process development. A critical step to improve our process development, process monitoring and process control is to understand the strength and limitations of each types of modeling approaches. Using the most relevant empirical approaches - from DoE to Multivariate Analysis - and the mechanistic understanding we have about our processes – Kinetics, thermodynamics – we are rethinking the way we conduct process development.
  • Development and Implementation of Intensified Bioprocessing for Biologics... Mar 12 2021 7:30 am UTC 120 mins
    Hang Zhou, Ph.D., Vice President, Head of Cell Culture Process Development Biologics and Bioprocess Dept. at WuXi Biologics
    Full Title: Development and Implementation of Intensified Bioprocessing for Biologics Manufacturing

    There are increasing needs for flexibility and speed in bioprocessing, as well as lower Cost of Goods in biologics manufacturing. In order to accelerate biologics development and manufacturing as well as to improve affordability of biologics, WuXi Biologics developed a proprietary biologics production platform, WuXiUP, with Ultra-high Productivity. With WuXiUP the cell culture has achieved productivity of 2.5g/L/day and 51g/L bioreactor volume in a 20-day process for an Fc-fusion protein. The Platform enables almost any biologics, including mAbs and fusion proteins, to be manufactured at ultra-high productivity. The intensified and continuous cell culture process can be rapidly developed or converted from traditional fed-batch process with excellent scalability and robustness. This next generation biologic manufacturing solution enables 1,000-2,000L disposable bioreactors to achieve similar productivity as traditional 10,000-20,000L stainless bioreactors, which will expedite product launch and significantly reduce the Cost of Goods of a commercial product.
  • Manufacturing in the Industry 4.0 era... Mar 10 2021 3:00 pm UTC 120 mins
    Christos Varsakelis PhD, Team Lead AI/ML at Janssen & Mark Demesmaeker, at Sartorius & Roger-Marc Nicoud at Ypso-Facto
    Full Title: Manufacturing in the Industry 4.0 era: how to balance innovation with performance while not being disrupted

    The manufacturing status quo reflects a compromise between innovation and performance. But the battle between these values is perpetual and, in the dawn of Industry 4.0 era, a new compromise between technological progress and the need for stationarity is being crafted. Being able to successfully harvest the benefits of the fourth industrial revolution requires a) separating facts from fiction and b) getting acquainted with the never-before-encountered bottlenecks that will have to be deal with. In this talk, we will go through the unique opportunities and the unprecedented challenges accompanying the fourth industrial revolution. The point of view, however, is not that of the salesman, which is frequently encountered online, but rather of the buyer, i.e. manufacturing.  The objective, therefore, is simple, albeit arduous: transform the buyer of this negotiation table into an informed investor that no-longer faces a competitive disadvantage.
  • Demonstrate how machine learning tools can aid development of formulation... Mar 8 2021 3:00 pm UTC 120 mins
    Rolf Taaning, Development Specialist PhD, and Erik Skibsted, Principal Scientist PhD at Novo Nordisk Denmark
    Full Title: Demonstrate how machine learning tools can aid development of formulation, analysis and manufacturing of pharmaceutical drug products

    Novo Nordisk has initiated several optimisation projects using machine learning tools and robotics as alternatives to traditional design of experiments (DoE) methodologies and hands-on experiments. The reasoning is a pursuit to find better optima using fewer resources. In this webinar Rolf Hejle Taaning and Erik Skibsted from Novo Nordisk will demonstrate optimisation of pharmaceutical liquid formulations and chemical reactions using a mix of different tools like Bayesian Optimisation, Principal Component Analysis and Robotics.
  • A Data Driven Biopharmaceutical Manufacturing Facility-Plug and Produce... Mar 4 2021 3:00 pm UTC 120 mins
    Presented by Josef Trapl Global Manufacturing & Supply, Head of MSci Innovation
    Full Title: A Data Driven Biopharmaceutical Manufacturing Facility-Plug and Produce -Shaping the Future Together

    With the high priority buzzwords “Industry 4.0” and the “IIoT” (Industrial Internet of Things) the Biopharma industry amongst the other partners in the Life Science / Healthcare industry strives toward a future purely data driven research, development, manufacturing and supply. From a technological perspective everything seems to be possible and in place starting from IaaS, SaaS, PaaS etc. up to the usage of 5G and associated devices. This means shop floor machinery and lab equipment will be connected plug & play like the printer at home and a bi-directional communication with real time data exchange to other software systems will be in place right first time when starting the production. Related business processes can be automated and data analyzed at any time at any place.  

    The reality looks different and a lot of companies are in the phase to build the foundation for a potential future scalable digital (IT/OT) platform. There are a lot of challenges where a good guideline is the maturity model which shows you exactly the “Status Quo” of your existing brownfield or new greenfield bioproduction facility. The Webinar will help you in a common discussion to understand the current challenges and how to materialize opportunities towards our digital Biopharma industry journey.
  • Process Development & Manufacturing Technologies for Bio-therapeutics... Mar 3 2021 9:30 am UTC 120 mins
    Atin Tomar, and Nirav Desai at Yapan Bio
    Full Title: Process Development & Manufacturing Technologies for Bio-therapeutics and Vaccines

    Presented by Atin Tomar, Co-Founder & CEO at Yapan Bio and Nirav Desai, Co-Founder at Yapan Bio
  • Improving Efficiency in Upstream Process Development Mar 1 2021 3:00 pm UTC 120 mins
    Jackie Gonzalez, Senior Upstream Development Engineer at Takeda, Klaus Mauch, CEO at Insilico Biotechnology AG
    The time required to develop and produce a new molecule and put it in the hands of patients is an important consideration in the drug development process. Utilization of novel tools, such as high-throughput systems and modeling allow for increased and more targeted development, ultimately reducing timelines and costs. Here, we demonstrate the application and impact of these tools on major activities in upstream process development.
  • Operational Excellence in Process Development in Drug Substance Production Feb 11 2021 6:30 am UTC 120 mins
    Presented by Ken Green, Ph.D, Head of MSAT at Samsung Biologics and Klaus Mauch, CEO at Insilico Biotechnology AG
    This presentation will highlight Samsung Biologics (SBL) approach to align process development activities with technology transfer and cGMP manufacturing. This alignment allows for rapid technology transfer with robust and compliant manufacturing. In addition, the alignment of process development with regulatory requirements allows SBL to provide a comprehensive regulatory CMC data package including process controls, validation, product comparability and stability.

    Process development at SBL is embedded within the manufacturing organization and as such colleagues have extensive understanding of at-scale equipment and manufacturing operations across all SBL facilities ranging from 1,000L to 15,000L scale. With 62 licensed products manufactured at SBL, process development colleagues have amassed a broad range of experience and best practice across diverse cell culture and purification processes.

    The application of standardized process operating procedures enables process development to streamline laboratory scale models and testing to accurately predict at-scale process performance. Technology transfer accelerants include the application of standardized process platforms, manufacturing best practice and small scale laboratory/virtual models. Finally, the development of robust transactional processes for process characterization, technology transfer and process validation enables their efficient application across SBL to fully support cGMP manufacturing corresponding to the product lifecycle phase.
  • Future Trends To Control Risks From Extractables and Leachables Feb 9 2021 3:00 pm UTC 120 mins
    Presented by Jason Creasey, Managing Director at Maven E&L Ltd and Kathleen Lava PhD – E&L Expert Nelson Labs Europe
    Presented by Jason Creasey, Managing Director at Maven E&L Ltd

    Jason Creasey is a graduate Analytical Chemist. He has recently setup as an independent consultant providing advice in the area of extractables and leachables, after working for GSK in the area of extractables and leachables since the mid 1990’s.

    Over that time, he has seen demand in this area grow exponentially and Jason has held roles of increasing seniority relating to the support that GSK has given to extractables and leachables (E&L). Before setting up Maven E&L Ltd, he was the director of a team of analytical chemists who are responsible for GSK’s global R&D support for E&L activities across a wide range of product types and modalities. This included; biopharmaceutical and small molecules including Inhalation, Parenteral and Cell & Gene Therapy use. He has had the pleasure of commenting on PQRI guidelines on E&L for GSK, the E&L section in EMEA guidelines on inhalation and nasal products and co-authoring a chapter within a book entitled “Leachables and Extractables Handbook: Safety Evaluation, Qualification, and Best Practices Applied to Inhalation Drug Products”.

    Jason has been a member of several external groups concerned with the development of best practice guides for extractable and leachables issues these include; the IPAC-RS material working group, BPOG and continues as a scientific advisor to Extractable and Leachable Safety Information Exchange otherwise known as ELSIE. Currently he is working and commenting on risk- based approaches to E&L requirements, which he hopes will form part of an ICH guidance in the not too distant future.

    Followed by Challenges and Best Practices for Extractables and Leachables in ophthalmic drug products. Presented by Kathleen Lava PhD – E&L Expert Nelson Labs Europe
  • Changing the Paradigm: Moving to In-Process Release Testing Feb 5 2021 3:00 pm UTC 120 mins
    Presented by Scott Weiss, Johnson & Johnson and Lori Daane at bioMérieux
    Changing the paradigm – moving to in-process release testing is a presentation to explore the possibilities of the future.  We will discuss limitations of traditional methods of monitoring and release, and investigate the existing challenges of current rapid method technologies.  What are we missing?  If we change our way of thinking around the acceptable limitations of traditional methods and look to the future with existing technologies and those on the horizon, using an end-to-end mindset, we can build the better mouse trap within our processes.  We can identify key markers with real time monitoring, using big data, so that by the end of the manufacturing process there is no need for final product microbiological quality testing.
  • Continuous Capture and Continuous Recovery - Novel Ideas for Product Recovery.. Feb 3 2021 3:00 pm UTC 120 mins
    Kerstin Lange and Andrew Falconbridge at Alvotech
    Alvotech developed an intensified fed-batch process using a cell retention device for the production of a complex fusion protein. The process uses the novel technique of High Productivity Harvest (HPH), which involves a traditional FB process and a clarification process using a cell retention device. Implementing the new process resulted in higher vcd and viability, improved product quality, and a reduction of cost of manufacture compared to the conventional fed-batch process.

    Alvotech developed an intensified fed-batch process using a cell retention device for the production of a complex fusion protein. The process uses the novel technique of High Productivity Harvest (HPH), which involves a traditional FB process and a clarification process using a cell retention device. Implementing the new process resulted in higher vcd and viability, improved product quality, and a reduction of cost of manufacture compared to the conventional fed-batch process.
  • How can you Best Use Network Analytics and Modelling To Support Digital... Feb 1 2021 3:00 pm UTC 120 mins
    Presented by Gareth Alford, Lead Engineer at GSK and Bob Lenich, Director of Life Sciences Business at Emerson
    Full title: How can you Best Use Network Analytics and Modelling To Support Digital Engineering In Pharma Manufacturing Operations

    Using the development of continuous manufacturing modules as a platform to look at the opportunities that arise through digitalization. The modular continuous manufacturing approach has allowed the detailed development of reproducible digital assets. These have in turn allowed the development of process models, mechanistic and statistical, to sit along side the process development through to manufacturing. The discussion today will look at discussing the challenges, both technical and cultural, and the opportunities that exist both now, and down the line as we build upon the experiences. We will concentrate on the benefits associated with the continuous platform, although the approach is applicable in a wider context, albeit with different technical challenges. Some areas that we will look to explore through the discussions will include the use of the models as part of regulatory filing, the use of the platform as an open source engineering set to build adoption, and how digitalization of our process understanding changes the fabric of the facilities that we operate.
  • Janssen CM-strategy: A Story of Multiple Platforms From R&D to Commercial Recorded: Dec 3 2020 103 mins
    Presented by Jeroen Geens, Engineering Technical Director at Janssen Research & Development
    After initial CM projects and successes for specific compounds in its commercial portfolio, Janssen defined in 2015 a vision to make continuous manufacturing the default platform for the development and launch of its entire portfolio or oral solid dosage forms.
    The Janssen vision has been translated in an end-to-end CM strategy and deployment plan, across R&D and Operations, demonstrating the need to have access to different CM technology platforms in order to achieve this goal. As part of this strategy, Janssen invested in its Mirror platform, redesigned the development approach in view of Continuous Manufacturing and built external partnerships.
    Important in successful deployment of the CM strategy is to continuously stick to the initial vision, despite the many challenges on the journey. While being pragmatic but selective in accepting outliers, not to be brought on CM, Janssen is shaping its CM-platform and network is not only for, but mainly through the R&D-portfolio.
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  • Presented by: Danny Chou, President and Founder at Compassion BioSolution, LLC
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