OP White Papers - random

  1. Platform Approach To Purification Of Bacterial Capsular Polysaccharides For Vaccine Production
    8/3/2018

    Capsular polysaccharides (CPS) of encapsulated bacterial pathogens can give rise to an effective immune response in humans, and are commonly used in vaccine production. This whitepaper offers an overview of modern tools and technologies that can facilitate CPS-based vaccine production. An alternative purification approach based on chromatography, replacing many of the ethanol and phenol extraction steps of the traditional process, is also presented. Using the proposed purification platform, 28 different CPS of three different species could be processed to high purity and yield in a secure and environmentally friendly way.

  2. Standarizing Biosample Management - Why Use Collection Kits?
    2/11/2019

    Whether you are conducting a phase 3 clinical trial of a new therapy or looking for biomarkers, you will need to collect samples, and that leads to a number of questions. Following are some basics to help with planning sample collection and to help make the process as cost-effective as possible.

  3. Top 10 Questions To Ask Your Clinical Supply Vendor About Temperature Sensitive Drugs
    6/13/2016

    Over the years, an entire system called ‘cold chain supply (or cold chain transport)’ has developed in the food industry to ensure that foods that need to be kept cold are stored and transported in appropriate conditions and are monitored so consumers and regulators can be assured of their safety.

  4. 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.

  5. 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.

  6. Managing Demand Uncertainty In Biologics Production
    8/9/2017

    How starting early, building options into your process, understanding the lead times, and continuing to evaluate your strategy can reduce uncertainty in your plans.

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

    Hemolysis is a primary driver of the need for re-draw, resulting in wasted time and resources. This paper explains how can hemolysis be prevented during specimen collection as well as hemolysis and specimen handling.

  8. 6 Myths About Biocatalysis Every Manufacturer Should Ignore
    4/12/2018

    By dispelling the myths associated with biocatalysis, a manufacturer can reap the benefits of this technology, providing a route to greener, safer chemistry that delivers a higher overall yield.

  9. Pharma Production Tech Transfers: Reaping Rewards, Reducing Risks
    7/24/2017

    Transferring production — and the technologies that undergird it — can be risky. The same product can behave differently in different equipment, resulting in low yields or even batch rejections.

  10. 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.