OP White Papers - random

  1. How To Survive An FDA Audit

    Understanding the FDA audit process, preparing for it and being aware of regulations will help to restore a sense of control and help to ensure the best outcome.

  2. 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.

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

    Biopharmaceutical executives must consider how outsourcing fits into their development and production strategy, as well as how to select the best CDMO partner for their business. Here’s a step-by-step guide to help make that decision.

  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. Multiplexing: Managing Risk With Proven, Single-Use Solutions
    11/27/2017

    With many uncertainties when introducing a new drug to market, seeking manufacturing flexibility to accommodate diverse demands and production needs is key.

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

    This white paper 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 of working that manufacturers can use to avoid microbial contamination.

  7. 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.

  8. 9 Reasons To Consider A Single-Use Fermentor

    Dedicated Fermentation Technology Replacing Stainless Steel Systems in Bioprocess Markets

  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. 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.