OP White Papers - random

  1. Critical Factors Of Fill Finish Manufacturing For Large Molecules 10/1/2019

    Compared to small molecules, large molecules generally require special handling procedures for the bulk drug substance, formulation, and sterile filtering and filling of the final drug product, which is forcing changes at nearly every level of the manufacturing process.

  2. Cold Chain Qualification: 5 Questions You Must Ask When Shipping Biologics 2/11/2019

    Organizations recognize the growing need for control of the entire cold chain as the changing global scenario requires highly efficient processes and flexibility.

  3. Critical Considerations About The Future Of Global Cell Culture Bioprocessing 4/2/2019

    In today’s changing industry, it is critical we consider several factors about cell culture bioprocessing and the impact they will have on the future of patient treatment.

  4. Benefits And Challenges Of Driving Modernization In Vaccine Development 6/11/2019

    Protein Sciences learned several valuable lessons during the development and final regulatory approval of its recombinant hemagglutinin (rHA) influenza vaccine, Flublok.

  5. Component Selection: The Key To Your Program Success 10/1/2019

    The increasing global adoption of injectable medicines creates demand for pre-filled syringes and vials. CDMOs that provide aseptic fill and finish services are actively responding to this increased demand.

  6. The Use Of Cell-Free Synthesis In The Future Of Modern Medicine 4/2/2019

    Cell-free synthesis systems are well suited to manufacture at the point of treatment, yet there are several challenges transitioning to this more efficient model for the future of medicine.

  7. ICH Q12 Updates: Increasing Efficiency Of Post-Approval Changes 4/2/2019

    Through proper implementation of ICH Q12 tools and enablers, the industry could manage CMC changes effectively under a company’s pharma quality system with less need for oversight prior to implementation.

  8. More Efficient Bispecific Antibody Purification With Fewer Steps 2/28/2019

    A single-step downstream process using protein A chromatography to purify a bispecific antibody (BsAb) in early screening has been successfully developed to replace an existing-three step process.

  9. Guidelines To Bring Your Biologic To Market: Are You Prepared? 4/16/2019

    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.

  10. Can Your Clinical Supply Chain Pass The Brexit Pressure Test? 3/13/2018

    - Clinical trial sponsors and clinical supply vendors must fully consider all attributes of their supply chains to ensure continuity of supply post-Brexit. This whitepaper outlines many questions that sponsors and vendors alike should ask