OP White Papers - random

  1. Unlocking The Potential For Efficiency In Downstream Bioprocesses
    6/16/2016

    In the bioprocessing industry, in order to make full use of upstream advances in an efficient manner, it is essential that downstream processes are intensified.

  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. Improve Operational Efficiency In Biomanufacturing With Comprehensive Automation Solutions
    10/26/2016

    This white paper outlines how connectivity and comprehensive automation solution can facilitate technology transfer and scaling from process development to final manufacturing scale.

  4. 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.

  5. More Efficient Bispecific Antibody Purification With Fewer Steps
    2/28/2019

    A single-step downstream process using protein A chromatography to purify a bispecific antibody (BsAb) in early screening has been successfully developed to replace an existing-three step process.

  6. 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.

  7. 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.

  8. Towards A Unified Process Development Strategy For Batch And Continuous Chromatography

    Here we describe a process development methodology that enables design of either a batch or a continuous chromatography step based on the same set of experimental data.

  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. Broaden Analysis Of Compound Factors For Predictive Solubility Solutions
    3/2/2017

    Developed by the FDA, the Biopharmaceutics Classification System helps companies when they file for bioequivalence of dosage forms based on in vitro dissolution testing.