Outsourced Pharma White Papers

  1. 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.

  2. The Race To Phase III: A Cautionary Tale Of Scalability
    10/30/2017

    Follow the paths of two companies as they learn how a science-led, risk-based development approach yields a more successful outcome in the long run.

  3. Off-Site Storage Of Biological Specimens And Biologics For Risk Mitigation
    2/11/2019

    Choosing an offsite storage facility means asking the right questions to determine if the storage provider has the appropriate risk mitigation infrastructure in place, beginning with a realistic threat assessment.

  4. Understanding And Controlling Raw Material Variation In Cell Culture Media
    9/5/2019

    An organized effort across the biopharmaceutical industry, including drug substance manufacturers and suppliers, is needed to address and meet the needs of industry regarding raw material quality and consistency.

  5. 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.

  6. 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.

  7. 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.

  8. 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.

  9. 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.

  10. Is Your Partner Prepared For Your Scale-Up And Commercialization Challenges?
    6/26/2019

    Most early-stage companies are not equipped with the means necessary for successful scale-up and commercialization, so it is critical you find a partner that can help you overcome the inevitable challenges of drug development.