INSIGHTS ON CELL & GENE OUTSOURCING ISSUES

  • 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 to market? Do you have a strategy and plan in place? Explore some of the questions to consider in order to map out a successful pathway and avoid pitfalls.

  • 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.

  • Cell Therapy: Process Design Considerations To Support Commercialization
    Cell Therapy: Process Design Considerations To Support Commercialization

    Cell therapies have the potential to revolutionize the biopharmaceutical world, but today’s processes, logistics, and delivery make for a challenging entry into the sector’s growth curve. As the industry evolves, we have to answer (at least) three important questions when bringing these exciting new therapies to market.

  • Designing The Cell Therapy Facility Of The Future
    Designing The Cell Therapy Facility Of The Future

    In 1931, Swiss doctor Paul Niehans injected a preparation of live cells from a parathyroid gland into a dying patient. The patient subsequently recovered, and Dr. Niehans had a eureka moment — that injections of living cells can have tremendous therapeutic value.

  • Chasing The Biopharma Market
    Chasing The Biopharma Market

    From new customer bases and vaccines to biosimilars and antibodies: what are the emerging trends and hot topics in biopharma, and how can companies take advantage of them in order to succeed?

  • Speed Biologics To Clinical Trials Faster
    Speed Biologics To Clinical Trials Faster

    If your business strategy doesn’t fully align with your organization’s capabilities in terms of expertise, capacity, and resources, it might be wise to consider outsourcing to a biologics CDMO for speed to market.

  • A Checklist For Engineering Due Diligence In Pharma M&As
    A Checklist For Engineering Due Diligence In Pharma M&As

    Pharmaceutical plants cannot be treated like real estate. Instead, they require a detailed assessment of where they are in “operational compliance and production readiness.”

  • Biocontainment: An Introduction To Control Levels & Practical Design Concepts
    Biocontainment: An Introduction To Control Levels & Practical Design Concepts

    In part 1 of our article on biocontainment, we discussed the history of biocontainment as an outgrowth of medical research, especially the effort to develop vaccines for various worldwide diseases. We provided some definition of the biosafety levels (BSLs) established by the Centers for Disease Control and Prevention (CDC) based on risk considerations. We also discussed the regulatory regime for biological agents and, specifically, for designing a facility for an FDA or EU regulated product within the confines of the safety practices dictated by the CDC and design requirements of the NIH.

  • Bioprocess Facility Design — Layout Rules And Configurations
    Bioprocess Facility Design — Layout Rules And Configurations

    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 third in a six-part series on how single-use systems are changing the modern biotechnology facility and process design paradigm.

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