OP White Papers - random

  1. In-House Versus Outsource: A Decision-Making Guide
    5/2/2018

    Biopharma executives must consider how outsourcing fits into their development and production strategy. Here’s a step-by-step guide to help make that decision.

  2. 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.

  3. 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.

  4. Overview Of A Scale-Up Of A Cell-Based Influenza Virus Production Process Using Single-Use Bioprocessing Equipment
    8/3/2018

    This paper includes a discussion on vaccine processes, followed by a case study on the scale-up of upstream and downstream processes for the production of a cell-based live attenuated influenza virus using single-use ReadyToProcess technology.

  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. Insights And Tips When Addressing Bioburden Challenges
    8/30/2017

    Addresses the challenges associated with the bioburden control process involved in making mAbs or other biologicals, as well as the single-use solutions and improved ways to avoid microbial contamination.

  8. 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.

  9. 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.

  10. Buffer Management Solutions For Large-Scale Bioprocessing
    2/1/2018

    How outsourcing and technologies such as in-line conditioning (IC) and in-line dilution (ILD) can help prevent resource constraints, save time, and reduce manufacturing footprint and overall cost in buffer preparation.