OP White Papers - random

  1. 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.

  2. Developing A Scalable Process For Adenovirus Manufacturing
    4/2/2019

    To address the growing need for speed and efficiency in viral vector manufacturing, GE developed a process for adenovirus manufacturing that not only meets regulatory requirements but is also scalable.

  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. 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. Some companies, especially those with limited experience in the biopharmaceutical industry, may find themselves unprepared when it comes to beginning the search.

  5. 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.

  6. 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.

  7. Is Your Complex Formulation Process Set Up For Success?
    10/1/2019

    Any company pursuing a drug delivery system that involves a complex formulation must be prepared for the requirements around this type of drug development to achieve successful scale-up.

  8. Rethinking Aseptic Filling: Innovations To Meet Pharma’s Challenging Requirements
    9/20/2019

    Current trends in drug development point toward a growing number of therapies that are targeting smaller patient populations. As the batch sizes required to manufacture clinical and commercial supply of these therapies are smaller than in the days of blockbuster medicines, the equipment and processes for manufacturing have had to change as well, creating challenges for smaller pharmaceutical companies. Rethinking aseptic filling from technology to process to service while meeting shifting market demands will help all participants in the pharmaceutical industry, and ultimately help the smaller patient populations who need targeted therapies.

  9. 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.

  10. 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.