Industry Insights

  1. Interacting With FDA During Biosimilar Development: From Initial Advisory Meeting To BLA 11/3/2020

    In Part 2 of this two-part article, we discuss what information is critical to support the sponsor’s argument that the proposed product is biosimilar to the designated reference product and when is it appropriate and at what level of detail it should be for each stage of interaction with the FDA.

  2. Navigate Complex Ancillary Supply Sourcing Challenges 8/1/2022

    Explore the evolvement of the clinical trial landscape over recent years, as well as the new challenges that this poses for the clinical supply chain. 

  3. Industry Trends: CDMO Outsourcing 10/5/2022

    No single CDMO strategy or outsourcing model is appropriate for every project. Outsourcers can and should evaluate a strategy and partner(s) on a case-by-case basis.

  4. Navigating FDA Guidance: Risk Management Plans For Potential Drug Shortages 9/8/2022

    Recent to "help stakeholders develop, maintain, and implement risk management plans (RMPs) to proactively assist in the prevention of human drug product and biological product shortages."

  5. How Reshoring, GLP-1s, And Supply Chain Security Are Transforming CDMOs 1/23/2026

    Explore how reshoring, GLP-1 capacity demands, and integrated U.S.-based manufacturing models are reshaping CDMO partnerships in a rapidly evolving pharmaceutical market.

  6. Learn How To Benefit From A Thoughtful Process Development Strategy 2/21/2023

    Learn how membrane chromatography using a novel membrane for the capture of antibodies can naturally address considerations when implementing a thoughtful process development strategy.

  7. Finding The Right CDMO Partner For Tech Transfer 2/17/2022

    Engaging a partner with the expertise and protocols for a comprehensive tech transfer is key to mitigating risks, such as unsatisfactory yields, materials shortages, or unoptimized batch sizes.

  8. Tools & Techniques For Biopharma Root Cause Analysis 8/10/2022

    In biopharma, we must provide a complete and thorough record of our thought processes in order to allow a third party to understand how we have arrived at the root cause of a given problem. This article follows a mock case study to demonstrate a progression of tools and techniques to use.

  9. Best Practices For Preformulation In Drug Development 12/14/2023

    Preformulation testing encompasses all studies performed on a new drug compound in order to produce useful information for subsequent formulation of a suitable drug dosage form. There is preformulation across the stages of drug discovery, early development, and late development. The route of administration dictates what is important.

  10. Nanoformed API: A Superior Alternative To Solid Dispersions 7/29/2024

    Cutting-edge nanotechnology is now emerging, able to address bioavailability challenges and deliver higher drug loads in more patient-friendly formats with fewer and smaller pills and easier regimens.