Outsourced Pharma White Papers

  1. CMC Strategies For The Development Of A Bispecific Antibody Platform for Cancer Immunotherapy
    5/31/2019

    Bispecific antibody development presents many challenges in product expression, bispecific purification, product stability, and scale up of the manufacturing process. 

  2. Choosing The Best Sterile Dosage Form For Your Phase 1 Needs
    5/2/2018

    When developing a parenteral product, pharmaceutical scientists are faced with a variety of choices — choices that can be conflicting or present differing advantages.

  3. What Clinical Teams Should Know About The Benefits Of Auto-Injectors
    8/20/2019

    For a host of reasons, auto-injectors are becoming biopharma companies’ delivery method of choice for commercial use and late-stage clinical trials. Auto-injectors ensure that the prescribed dose of medication is delivered fully and completely,making it easier to track compliance in clinical trials.

  4. 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.

  5. What Clinical Teams Should Know About Changing Trial Logistics
    2/27/2019

    When it comes to clinical supplies, the journey is every bit as important as the destination and the price of failure is high. This paper discusses how supply logistics are changing and contains examples of how Fisher Clinical Services is deploying flexible solutions to ensure secure, efficient and cost-effective passage of clinical supplies.

  6. 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.

  7. Scalable Strategies For Parenteral Dosage Form Selection
    12/29/2017

    Understand the strategies which can be employed at the different stages of development when choosing parenteral dosage forms.

     

  8. Off-Site Storage Of Biological Specimens And Biologics For Risk Mitigation
    2/11/2019

    Choosing an offsite storage facility means asking the right questions to determine if the storage provider has the appropriate risk mitigation infrastructure in place, beginning with a realistic threat assessment.

  9. Utilizing External Collaboration To Accelerate Vaccine Development
    11/2/2018

    Securing a partner to serve as an extension of Janssen’s Biotherapeutics Development API-Large Molecule team was essential to reduce both risk and the time needed for delivery of clinical supplies.

  10. 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.