Outsourcing Pharma

  1. Regulatory Update: CDMOs And Contamination Control Strategy 3/1/2023

    With the August 2022 released revisions to Annex 1 of the EMA’s Eudralex Volume 1 and the increased expectations it brings to sterile drug producers, CDMOs are finding their sterility assurance programs in a position that will require a new level of transparency with sponsors.

  2. Create The Correct Checklist To Land The Best CDMO 3/1/2023

    In this article, we discuss CDMO assessment and show how to construct an agreement between partners that favors fluid communication and alignment of business objectives — crucial for a fruitful sponsor-CDMO relationship to diminish overall risk for both.

  3. CDMO Partnerships In Early Development Aren't Always The Best Choice 12/7/2022

    This article looks at the needs and challenges biotech organizations face during the manufacture of therapies, how they can reduce cost, and how establishing — or not establishing — partnerships with CDMOs can help get their therapies to patients faster.

  4. A More Balanced And Stable Future With CDMOs 12/1/2022

    Two Industry Experts talk about where they see the outsourcing industry going in the near future.

  5. 6 Reasons Why India Is The Future Of Global Production Of APIs 10/3/2022

    Here is why, in my view, India will be essential to the future of global drug production.

  6. What Is A Risk-Based Approach To CRO Oversight? 10/3/2022

    Ian Wyglendowski, the head of strategic clinical partnering at UCB, recommends taking a risk-based approach to CRO oversight, and gives specifics that you can implement.

  7. Manufacturing CGTs: Should I Use A CDMO? 9/30/2022

    Given the current regulatory framework, manufacturing issues are a major challenge for sponsors of cell and gene therapies. This article shares some key questions and considerations you should ask yourself in order to make the decision whether or not you should use a CDMO.

  8. 2022 Outsourcing Trends In Biopharmaceutical Manufacturing 6/15/2022

    The continued focus on productivity and efficiency is moving manufacturers to increasingly consider outsourcing activities. Biomanufacturers are spending more, demanding better technologies, and expressing greater optimism. This article shares the trends in outsourced activities, percentages of activities outsourced, outsourcing destinations, and offshoring.

  9. How To Build A Strong CRO Partnership And Find Drug Development Success 6/1/2022

    Building a collaborative and highly engaged partnership with a CRO to optimize study enrollment is critical for a company’s success, particularly with so much reliance on virtual interactions. Here are some tips on how to do just that.

  10. Why I'm Thankful For Sponsors And CROs 6/1/2022

    There are many patients out there who depend on those efforts and the amazing medicines that result from them. I am now one of them.