INSIGHTS ON CELL & GENE OUTSOURCING ISSUES

  • 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.

  • An Introduction To Biopharmaceutical Facility Design & Layout
    An Introduction To Biopharmaceutical Facility Design & Layout

    This article explores modern facility design principles that make use of the most flexible new technologies and provide a platform to rein in costs, reduce schedules, and deliver products compliantly and within business risk tolerance.

  • Single-Use Systems For Aseptic Fill/Finish
    Single-Use Systems For Aseptic Fill/Finish

    Today’s disposable systems offer improved manufacturing efficiency, and better QA and regulatory compliance — and they can be the fastest route to media fills

  • Considering Options And Alternatives For The Design Of Complex Biopharma Facilities
    Considering Options And Alternatives For The Design Of Complex Biopharma Facilities

    The movement of viral vectors, cell therapies and other antibody-based next-generation drug products toward commercialization is driving the need for new and different technologies and facilities. Engineering and design firms with the right skill sets can help you maintain the right balance in your facility design to maintain flexibility which is essential to meet diverse processing needs for biopharmaceutical manufacturing.

  • Aseptic Processing Services
    Aseptic Processing Services

    We are internationally recognized as experts in advanced aseptic processing and risk-based isolation and barrier technologies. Our experience, awareness and understanding of industry trends places importance on time-to-market, plant flexibility and cost control to avoid costly project delays and minimize risk.

  • Drug Development And Tech Transfer Services
    Drug Development And Tech Transfer Services

    Whether the products are new or existing, our Drug Development and Technology Transfer services offer solutions that consistently maintain quality and compliance to effectively accelerate scale-up through market launch. Our experts provide ideas that speed pharmaceutical and biotech products to market.

  • Laboratory Project Services
    Laboratory Project Services

    Our team has the experience and technical knowledge to execute the most complex, demanding laboratory projects. Our unique approach combines the design elements with operational excellence, energy efficiency and risk and safety assessment as required to meet your laboratory needs.

  • Process And BioProcess Engineering Services: Cell And Gene Drug Manufacturing
    Process And BioProcess Engineering Services: Cell And Gene Drug Manufacturing

    Knowing the technology, industry trends, regulatory environment and manufacturing processes enables our process/bioprocess engineers to identify opportunities to streamline production and maximize efficiency.

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