Outsourced Pharma White Papers

  1. 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.

  2. 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.

  3. Flow Chemistry: Scale-Up Solution For Modern API Manufacturing 2/20/2019

    Once deemed an “experts-only” approach to chemical synthesis, flow chemistry is a cost-efficient technique growing in popularity that can increase safety and flexibility and improve product quality.

  4. 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.

  5. In-House Versus Outsource: A Decision-Making Guide 5/2/2018
    Biopharmaceutical executives must consider how outsourcing fits into their development and production strategy, as well as how to select the best CDMO partner for their business. Here’s a step-by-step guide to help make that decision.
  6. Preparing For Your CDMO Selection Process 10/1/2019

    Finding the CDMO that is right for your company and project can be a daunting task, particularly if this is your first time outsourcing. Don't be unprepared from the outset of your search. 

  7. CMC Strategies For 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. 

  8. 6 Regulatory Changes Affecting Bioprocessing In China 4/2/2019

    This article outlines six recent regulatory changes in China intended to protect patient safety as well as reduce regulatory burdens and minimize delays.

  9. 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.

  10. 5 ADC Manufacturing Challenges You Need To Know 10/1/2019

    Despite tremendous growth, drug makers still face a number of challenges in the manufacturing process for antibody-drug conjugates (ADCs). Here are key areas where pharma faces uphill battles.