OP White Papers - random

  1. A Common Sense Approach To Sustainability In The Biosimilar Business
    4/2/2019

    Through common sense and creative thinking, the industry can discover new ways to achieve success and sustainability in the biosimilar market.

  2. Understand Your Process: A Key To CMO Risk Mitigation
    9/17/2019

    The advantages of contract manufacturing come with certain practical risks. Many of those risks are associated with inadequate communication and knowledge transfer between the drug’s originator and the CMO. Throughout this paper on CMO risk mitigation, we will approach the subject from the perspective of a sterile drug product CMO and establish methods to reduce project risks when moving from the laboratory to a GMP manufacturing setting.

  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. 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.

  5. Efficient Cleaning-In-Place Methods For Protein-Based Antibody Affinity Chromatography Resins
    10/2/2018

    This whitepaper discusses cleaning of affinity resins intended for use in the purification of monoclonal antibodies and antibody fragments.

  6. Development Pathways For ATMPs: Virus Safety Challenges And Regulatory Perspective
    6/11/2019

    There is an increased risk of viral contamination in settings where ATMPs are prepared, making it critical to understand the contamination risks and the solutions available to control them.

  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. 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. 

  9. Virus Safety For Continuous Processing
    9/5/2019

    Transitioning to a continuous processing approach requires the implementation of an effective virus clearance strategy, which is intended to prevent various virus contaminations that could threaten patient safety.

  10. Overcoming Bioavailability Challenges In Oral Formulation Development
    8/27/2019

    With nearly 90 percent of the developmental pipeline drugs consisting of poorly soluble molecules, formulation experts must be prepared to address this obstacle by applying various approaches to improve an API’s pharmacokinetics.