OP White Papers - random

  1. The Future Of BioManufacturing

    The biomanufacturing industry is undergoing a major shift, from single-product processes and stainless steel infrastructure to flexible, multi-product facilities using single-use technology.

  2. The 3 Cs You Should Expect From Your Pharma Service Provider
    9/13/2016

    When asked about the biggest challenges to the pharmaceutical company sponsor-contract service provider relationship, sponsors and service providers offer pretty consistent responses.  

  3. Scalable Strategies For Parenteral Dosage Form Selection
    12/29/2017

    Understand the strategies which can be employed at the different stages of development when choosing parenteral dosage forms.

     

  4. The Timely Rise Of The CDMO
    6/1/2016

    A new breed of solution-centric CDMOs has emerged, with capabilities spanning the entire development and manufacturing process from preclinical drug development to commercial manufacturing. 

  5. Continuous Biomanufacturing: 10 Reasons Sponsors Hesitate

    By William Whitford, Strategic Solutions Leader, BioProcess, GE Healthcare Life Sciences

    The industry is abuzz with talk about continuous biomanufacturing (CB), and its virtues have been well described. Here we will look at some of the barriers or concerns perceived to limit its value to the industry. Justified or not, quite a few concerns have been expressed regarding the implementation of this new, rather disruptive technology. 

  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. Bioburden: Addressing Microbial Contamination In Downstream Bioprocessing
    8/30/2017

    A discussion on the risks related to bioburden downstream processing and ways to mitigate them. Topics covered include improvements in raw material, equipment design, and chromatography resin properties.

  8. 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.

  9. Drug Safety And Product Protection Driving Blister Packaging Growth

    Trends in packaging of prescription and over-the-counter drugs indicate continued growth in the blister packaging market. 

  10. 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.