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BioPharma Asia Magazine

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  • Extractables and Leachables have been used interchangeablely for too long. Are w
    Extractables and Leachables have been used interchangeablely for too long. Are w
    Ken Wong, Deputy Director at Sanofi Pasteur and Don DeCou, Extractable and Leachable Technology Manager at West Pharma Recorded: Mar 25 2019 77 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
  • Transformational Science: Moving from Challenges of High Concentration Protein..
    Transformational Science: Moving from Challenges of High Concentration Protein..
    Sachin Dubey, Ph.D., Head of Formulation and Analytical Development at Glenmark Pharmaceuticals SA Recorded: Mar 19 2019 35 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.
  • Understanding the Propensity of Sequence Variants During Cell Line & Culture...
    Understanding the Propensity of Sequence Variants During Cell Line & Culture...
    Dr. Lisa Marzilli, Associate Research Fellow and group leader Mass Spectrometry at Pfizer, USA Recorded: Mar 18 2019 40 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.
  • Integrity Assurance for SUS: End-User Perspective
    Integrity Assurance for SUS: End-User Perspective
    Charlotte Masy, Project Manager in global support GSK vaccinés and Donald Young, Sr. Product Manager at Thermo Fisher Scienti Recorded: Mar 14 2019 61 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 .
  • Managing Biologics Process Analytical Technology in Pfizer
    Managing Biologics Process Analytical Technology in Pfizer
    Keith Davis, Principle Scientist at Pfizer Recorded: Mar 12 2019 21 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.
  • Achieving Seamless Scale-Up and Technology Transfer – A Case Study in Single-Use
    Achieving Seamless Scale-Up and Technology Transfer – A Case Study in Single-Use
    Ying Wang, Ph.D., Senior Scientist I, Manufacturing Sciences at AbbVie Bioresearch Center Recorded: Mar 11 2019 39 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 (
  • BPOG Risk Based Approaches To Use Of Closed Systems In Renovations Of Existing..
    BPOG Risk Based Approaches To Use Of Closed Systems In Renovations Of Existing..
    Lars Hovmand-Lyster of Novo Nordisk GPO and Ernest Jenness of MilliporeSigma Recorded: Mar 5 2019 76 mins
    BPOG Risk Based Approaches To Use Of Closed Systems In Renovations Of Existing Biopharma API Facilities

    Companies often experience regulatory challenges during inspection of aging facilities, requiring them to initiate projects to optimize product protection and updating to current standards for classified areas for biopharma manufacturing. For a long time the company response have been to improve the existing classified areas or maybe even upgrading to a higher grade of classification. However, it may be more appropriate, and improve product protection, to instead implement the use of closed system processes and downgrade room classification during these facility renovation projects. If closed systems are fully utilised, then a CNC space can be used. As well as reducing complexity of operations, this will reduce capital and operating costs.
    This presentation elaborates the work of BPOG members to harmonize the use of closed systems and define risk based tools and approaches to evaluate appropriate room classification across the Biopharmaceutical industry.
  • Continuous Manufacturing: Business Case Drivers and Deployment Strategies
    Continuous Manufacturing: Business Case Drivers and Deployment Strategies
    Lawrence De Belder, Senior Principal Engineer at Johnson and Johnson and Richard Steiner, Business Development Manager at GEA Recorded: Feb 26 2019 81 mins
    Continuous manufacturing for Oral Solid Dose drug products has the potential to generate benefits in many different areas of the product life cycle. It will help to improve control and understanding, increase development and transfer speed, assure shorter cycle times, and reduce development, transfer and operational cost.

    If we look at the products which have been approved for commercial production, we see differences in technology, approach, and business case drivers. The main interest is coming from larger pharmaceutical companies, but also generic companies and CMO’s start to invest or have intentions to do so.

    Before implementing a continuous manufacturing process, a number of strategic choices have to be made: start off immediately with new products or learn by converting a legacy batch product into a continuous process without the critical deadline of a launch on your path. A clear development and deployment strategy will help to guide for important choices early on.

    This webinar will give an overview of the different elements that can drive the business case of a continuous manufacturing project, and which strategies could be used to deploy this wonderful technology throughout an organization.
  • Effect of Cell Culture Process Change from Fed-batch to Continuous on...
    Effect of Cell Culture Process Change from Fed-batch to Continuous on...
    Ru Zang, Associate Director at Mersana Therapeutics and John Bonham Carter,Project Line Lead at Repligen Recorded: Feb 25 2019 76 mins
    EFFECT OF CELL CULTURE PROCESS CHANGE FROM FED-BATCH TO CONTINUOUS ON PRODUCTIVITY AND PRODUCT QUALITY

    Integrated continuous bioprocessing has attracted a growing interest due to its potential to improve agility and flexibility in the manufacture of therapeutic proteins. To convert an existing fed-batch cell culture process to continuous, or perfusion, the major technical hurdles include maintaining steady state cell culture performance and generating product with comparable product quality attributes. In this presentation, we evaluated three molecules including a fusion protein, an aglycosylated monoclonal antibody (mAb), and a glycosylated mAb. Steady state culture at high cell density was achieved for all three molecules, which allows the delivery of products with consistent product quality and adequate productivity. However, as compared to fed-batch processes, product quality and cell specific productivity differences were observed in perfusion cultures. Further studies indicated that it was feasible to modulate product quality in perfusion process by adding process levers in culture medium. It was also feasible to increase cell specific productivity through medium and process optimization. This presentation provides an insight into the product quality and productivity differences between traditional fed-batch and perfusion cell culture processes and potential approaches to addressing these differences.
  • Quality-By-Design in Spray Drying Processes - Transfer Lab to Production
    Quality-By-Design in Spray Drying Processes - Transfer Lab to Production
    Sune Klint Andersen, Janssen Pharmaceutica & João Vicente Senior Scientist - Particle Engineering Team Leader at Hovione Recorded: Feb 19 2019 77 mins
    Spray drying is a continuous and scalable manufacturing process commonly used in the pharmaceutical industry. Due to its scalable and continuous nature it is possible to apply Quality-by-Design (QbD) and Process Analytical Technologies (PAT) early on in the development of a spray drying process.
    Knowledge gained from QbD e.g. Design-of-Experiments (DoE) and PAT increases process understanding and the knowledge can be readily applied when scaling up the process and in production scale application of PAT i.e. especially with respect to the control strategy.
    The Webinar will discuss the application of QbD early in the development and how the obtained knowledge can be used to optimize transfer of the spray drying process to production scale including PAT strategy.

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