INSIGHTS ON CELL & GENE OUTSOURCING ISSUES

  • Best Practices For A Successful Bioprocess Technology Transfer
    Best Practices For A Successful Bioprocess Technology Transfer

    A well-executed bioprocess technology transfer (tech transfer) is critical to ensure smooth knowledge transfer and optimal process reproducibility. If not executed properly, you risk reducing the quality and efficiency of your process. Waste time trouble shooting, and you may delay your time to market. In today’s global markets effective tech transfer is critical.

  • How Important Is Geography To Today’s Outsourcing?
    How Important Is Geography To Today’s Outsourcing?

    A recent CDMO press release essentially asserted superiority via proximity: Geography as God of outsourcing. I contacted two biopharma executives familiar with the Boston/Cambridge scene for reactions: Michael Kaufman, Senior Vice President, CMC, Mersana Therapeutics, and 15-year veteran of Merck; and George Avgerinos, Senior Vice President of Biologics Operations, Fortress Biotechnologies, and 22-year veteran of BASF/Abbott/Abbvie.

  • Catalent Biologics: Delivering Therapies To Market Faster
    Catalent Biologics: Delivering Therapies To Market Faster

    Catalent Biologics is an integrated partner with expertise to get a biologic to market faster. The company has the passion to help its partners accelerate, simplify and de-risk their biologic therapies -- from development and manufacturing, to fill/finish, clinical supply and commercial launch.

  • Catalent Clinical Supply Services
    Catalent Clinical Supply Services

    Whether you have a large, complex global study or need a small, regional solution, we can reliably supply your clinical trial anywhere in the world. From Phase I to Phase III and beyond, we are the catalyst for your success.

  • A Solution To Ensure Quantity & Quality Of The Excipient Polysorbate-80 In Drug Formulations
    A Solution To Ensure Quantity & Quality Of The Excipient Polysorbate-80 In Drug Formulations

    Polysorbate-80 (PS-80) is a surfactant commonly used as an excipient to improve API stability. However, degradation of PS-80 can lead to decreased drug potency or stability, and there is inconsistency in the quality and composition of PS-80 provided by different vendors.

  • How To Address Process Characterization And Late Phase Development Of A Monoclonal Antibody
    How To Address Process Characterization And Late Phase Development Of A Monoclonal Antibody

    Process characterization is an important step in the overall journey of product development. In this poster, scientists at propose a step-wise approach for the definition and execution of process characterization for the production of a monoclonal antibody.

  • Achieving Unique Synergies In Antibody Expression
    Achieving Unique Synergies In Antibody Expression

    Shortening timelines to generate more productive, stable and high expressing cell lines is the goal of any cell line development program. This technical poster details the methodologies and clonal variation of combining a cell line development technology with a platform for clonal cell line selection.

  • Guidelines To Bring Your Biologic To Market: Are You Prepared?
    Guidelines To Bring Your Biologic To Market: Are You Prepared?

    Are you up to the task of bringing a biologic drug to market? Do you have a strategy and plan for moving forward? Here we explore, from a biopharma process development and manufacturing perspective.

  • The Unique Demands of Cell and Gene Therapy Supply Chains
    The Unique Demands of Cell and Gene Therapy Supply Chains

    Three cell and gene therapy sector SMEs representing industry and academia explain supply chain challenges and viable solutions.

  • Dos & Don’ts Of Bioprocess Facility Construction
    Dos & Don’ts Of Bioprocess Facility Construction

    Expansions and renovations to existing biological facilities, and construction of new facilities, provide a unique opportunity to rethink basic design strategies and use new technologies to build a better facility that will improve compliance. This article is the sixth in a six-part series on how single-use systems (SUS) are changing the modern biotechnology facility design and construction paradigm.

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