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BioPharma Asia Magazine

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  • Evolve Manufacturing Processes by Implementing Disruptive Technologies
    Evolve Manufacturing Processes by Implementing Disruptive Technologies
    Yuyi Shen, Associate Director at Bolt Bio, John Cyganowski, Director of Manufacturing Sciences for MilliporeSigma Recorded: Nov 19 2018 77 mins
    The desire for innovative technology that can eventually cause disruptive changes remains high in the biotech pharmaceutical industry. The road between pursuing and developing that technology to genuine implementing is not a smooth ride. In this webinar, the presenter identifies key challenges of implementing innovative technologies and the major drive for implementing innovative technologies and process upgrades. The presenter will share some case studies of implementing successful innovation tools and provide comparative economic analysis based on the understanding the true value of innovation driven process design. The webinar also provide the insight of the balance needs for quality, cost and speed.
  • Mixed mode Chromatography in Purifying biologics - Overview
    Mixed mode Chromatography in Purifying biologics - Overview
    Vivek Halan Zumutor Biologics Pvt Ltd, Bangalore, India Recorded: Nov 15 2018 42 mins
    This Webinar will discuss MMC in purifying biologics which includes monoclonal antibodies (mAbs), Bispecific antibodies (BsAbs), antibody fragments (Scfv,Fab) and other recombinant proåteins. My discussion is intended for audience from biopharmaceutical industry as well as active collaborators from academic institutes.
  • Efficiency by Design- Case Study for a Hybrid Clinical Manufacturing Facility
    Efficiency by Design- Case Study for a Hybrid Clinical Manufacturing Facility
    Dr Sourav Kundu, Senior Director at Teva Pharmaceuticals Global Biologics R&D and Adam Kaletski, Business Leader, Bioprocess Recorded: Nov 9 2018 64 mins
    Clinical manufacturing facilities require the flexibility to configure the sequence of unit operations as well as equipment characteristics to fit diverse types of manufacturing processes.

    While stainless steel facilities remain as more traditional and suitable for large volume products, single-use facilities provide tremendous advantage for flexibility, infrastructure and capital costs, and start-up time. 

    Single-use equipment and single-use facilities are particularly suitable for clinical manufacturing due to smaller investment requirements, smaller footprint, reduced risk, and increased operational flexibility. 

    While single-use equipment are evolving and catching up to the functionality and reliability of stainless steel equipment, in some instances, stainless steel equipment may still be preferred. 

    We will be providing a description of a new clinical manufacturing facility where single-use and stainless steel equipment were combined in a strategic manner to meet the business objectives.

    Biopharmaceutical manufacturing facilities are designed and operated to meet business objectives at various stages of a product lifecycles. While large stainless-steel facilities are appropriate for large volume established products, smaller single-use facilities are more efficient for smaller volume manufacturing needs, particularly for clinical supplies. Stainless steel equipment can be combined with single-use equipment to create hybrid facilities to meet process needs and business objectives in a more efficient manner. Typical challenges with building and validating a biopharmaceutical manufacturing facility can be overcome by strategic planning, good execution and a high-performance team.
  • Regulatory Approval of Three Rapid Microbiological Methods for MACI Release
    Regulatory Approval of Three Rapid Microbiological Methods for MACI Release
    John Duguid, Senior Director, at Vericel Corporation in Cambridge, and Nicola Reid, Senior Product Manager at Charles River Recorded: Nov 8 2018 65 mins
    Title:Regulatory Approval of Three Rapid Microbiological Methods for MACI Product Release
    Rapid detection of contaminants is essential for cell therapy products with short shelf lives. Integrating quality into the process through lot segregation, raw material qualification, environmental control, personnel training, and detailed procedures is critical because final results for conventional microbiological tests may not be available prior to product release or patient administration. EMA approval of the MACI MAA in 2013 followed by US FDA BLA approval in 2016 included three RMM product release assays for sterility, endotoxin, and mycoplasma.
    Followed by Data Integrity: Eliminating Risk & Human Error by Utilising Cartridge Technology Presented by Nicola Reid, Senior Product Manager at Charles River – Microbial Solutions
    The human element can never be completely eliminated in Bacterial Endotoxin Testing, but what can be done to mitigate the risk for human error and how does it relate to the data integrity problem?
    Reducing the risk for human error in our manufacturing and laboratory processes will ensure that we comply with data integrity laws and regulations while building quality into our everyday processes and thus keeping our patients and our drugs safe. As laboratory testing shifts from observation-based qualitative methods to more objective quantitative methods, focus on data integrity becomes more critical to ensure overall product quality and patient safety.
    We’ll apply those principal to an invalid BET example to see how the result can potentially cripple your manufacturing timelines. There’s no mistake that the LAL assay is the gold standard for endotoxin testing, and advances in science have allowed for improvement in how it’s utilized. The end result is the revolutionary cartridge technology.
  • Advances and Challenges in Vaccine Development and Manufacture
    Advances and Challenges in Vaccine Development and Manufacture
    Tony D’Amore, Sanofi Pasteur Recorded: Nov 2 2018 41 mins
    This webinar reviews the constraints and complexities of vaccine product development and manufacture.
    The evolution of bioprocess and analytics innovation and technologies to overcome these challenges are discussed.
    The strategy and leveraging of innovation and technology for rapid product development and accelerating timelines is described.
    Case studies to illustrate the advances in vaccine development and manufacture are illustrated.
    A look into the future with state of the art technologies.
  • Extractables and leachables testing using a Quality Risk Management approach
    Extractables and leachables testing using a Quality Risk Management approach
    Dhaval Tapiawala, Pfizer and Satish Kumar Mohanvelu Life Sciences Management Professional at MilliporeSigma Recorded: Oct 17 2018 79 mins
    • 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
  • Impact of Depth Filtration on Disulfide Bond Reduction during Downstream Process
    Impact of Depth Filtration on Disulfide Bond Reduction during Downstream Process
    Brian O’ Mara, Senior Research Scientist I, Bristol-Myers Squibb and Alexei Voloshin, Global Application Strategy Specialist Recorded: Oct 8 2018 79 mins
    Title:Impact of Depth Filtration on Disulfide Bond Reduction during Downstream Processing of Monoclonal Antibodies from CHO Cell Cultures

    Presenters: Brian O'mara, Senior Research Scientist I, Bristol-Myers Squibb and Alexei Voloshin, Global Application Strategy Specialist
    • Understand disposable depth filtration technology used in the recovery of antibodies from CHO cell cultures as a unit operation leading to cellular lysis under particular operational conditions • Study how cellular lysis occurring during depth filtration releases endogenous REDOX regulating enzymes and co-factors into the clarified harvest, resulting in the reduction of antibody interchain disulfide bonds • Classify critical process parameters and quality attributes of the clarified harvest to be monitored during filtration development • Discuss risk mitigation strategies to control antibody reduction when using single-use disposable technologies in the recovery of antibodies from CHO cells
  • Implementing CMC Strategies for scale-up operations in biologics manufacturing
    Implementing CMC Strategies for scale-up operations in biologics manufacturing
    Dr Anita Krishnan, Lupinand -Dr. Annu Uppal, Global Demo Lead and Advanced Workflow Specialist at SCIEX Recorded: Oct 5 2018 73 mins
    Biotechnological products are so complex, that manufacturing biologics which are both cost-effective and with best product quality, is a technical challenge. In the context of biosimilar manufacturing at each step, the sponsor should evaluate the extent to which there is residual uncertainty about the biosimilarity of the proposed product. Often there is remnant quality difference beyond the capability of process to address. In such instances, in-depth understanding of the process, impurities, analytical methods, the mechanism of action (MOA) of the drug substance and clinical relevance of any observed structural differences, will help in implementing novel CMC strategies. This talk will examine the elements of biopharmaceutical development that lead to successful licensure of biotherapeutics.
  • Developability Assessment of Therapeutic Proteins – A Toolbox for Tackling Incre
    Developability Assessment of Therapeutic Proteins – A Toolbox for Tackling Incre
    Thorsten Lorenz, Team Head Developability Assessment Biologics, Novartis and Beate Kern, Product Manager, NanoTemper Recorded: Sep 27 2018 65 mins
    Title: Developability Assessment of Therapeutic Proteins – A Toolbox for Tackling Increasing Complexity
    Presenter: Thorsten Lorenz, Team Head Developability Assessment Biologics, Novartis

    Early lead selection of biotherapeutics during preclinical development requires careful characterization of a variety of molecule properties to reduce the risk for encountering unexpected obstacles during technical development. The diversity and increasing complexity of new protein formats requires a change from former platform approaches often applied for antibodies, to project specific strategies. The developability assessment concept applied at Novartis combines information addressing various technical areas, such as expression, aggregation propensity, process fit, stability, physicochemical properties, etc. This integrated concept prior to lead selection provides a thorough, yet resource efficient approach to select suitable candidates.
  • DSF and FTIR as methods for the identification and characterization
    DSF and FTIR as methods for the identification and characterization
    Marina Kirkitadze , Deputy Director, Head of Biophysics & Conformation Unit, Analytical R&D Biochemist & Kristen Kalbfleisch Recorded: Sep 18 2018 71 mins
    The focus of this presentation is the application of Fourier Transform Infrared Spectroscopy (FTIR) and Differential Scanning Fluorimetry (DSF) methods to characterize vaccine components and their stability. Additionally, FTIR can be applied for the identification of final vaccine products, and DSF can be used to distinguish different formulations of vaccine candidates. These methods, when used in conjuction, provide valuable information regarding characterization and stability in the final stages of vaccine manufacturing.

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