OP White Papers - random

  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. 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.

  3. 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.

  4. Bioavailability Enhancement: The Key To Unlocking The Potential Of Drug Development Pipelines 5/5/2020

    In this paper we look at the process CoreRx goes through when given an active ingredient with low bioavailability and four approaches that may be applied to increase the amount of the therapeutic that enters systemic circulation.

  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. Viral Clearance: The Basics On How To Conduct Effective Studies 5/17/2019

    Effective viral clearance studies remain one of the challenges facing manufacturers of biologics. These studies are an essential part of process validation and are critical to ensure drug safety. This article provides the basics of what you need to know when studying virus reduction of a chromatography step.

  7. 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.

  8. Pairing Data Connectivity, Automation Ease Tech Transfer/Scale-Up 2/11/2020

    In biopharma, process data is used in many ways throughout process development and production phases. This article outlines how connectivity and comprehensive automation ease tech transfer and scale up.

  9. Small Molecule Impurities: A Control System Design Challenge For ADCs 3/11/2019

    Composed of both antibody and small molecule elements, ADCs have a complex structure from which many different impurities can arise.

  10. Avoiding Hemolysis Blood Sample Collection Processing 2/11/2019

    Erythrocytes have significant value in specific types of research. If your objective is biobanking these cells in an intact state then it is equally important that hemolysis and the need for a re-draw is avoided. This paper explains how hemolysis can be prevented during specimen collection and handling.