Industry Insights

  1. Sponsor Challenges When Outsourcing Sterile Injectables

    Outsourcers of sterile injectable drug product were asked to identify their biggest challenge when outsourcing to CDMOs/CMOs. Here's a look at the resulting nearly four-way tie.

  2. Accelerating Innovative Cell Therapy Development Through Phase-Appropriate Potency Control 2/4/2025

    Developing a robust, phase-appropriate potency strategy is essential for ensuring the quality, consistency, and regulatory success of cell and gene therapies.

  3. An Analysis Of The Gene Therapy Viral Vector Landscape 4/21/2021

    Over the last five years, multiple gene therapies have been approved by regulatory agencies and a bolus of late-stage pipeline assets are approaching the market. However, as the first gene therapies began to post early wins, several challenges have emerged. This article discusses the landscape of the viral vector sector.

  4. The Building Blocks For Successful CDMO–Pharma Relationships For Packaging Operations 12/4/2024

    The building blocks of such successful packaging relationships include a thoughtful approach to quality service agreements, a culture of transparency, and more.

  5. Model-Based Control In Continuous Manufacturing of Biotherapeutics 11/10/2021

    During continuous processing, automated control techniques coupled with process analytical tools are required to monitor critical quality attributes and implement real-time control decisions to handle deviations. This article is the first in a two-part series examining how model-based control can be effectively implemented in the various unit operations.

  6. Insulin's 100-Year History Inspires Today's Biotech Industry 2/22/2023

    Former FDA regulator Jeffrey C. Baker, Ph.D., has been speaking on the history of insulin, the first biologic, at seminars and conferences for years. This year, those talks seem more important as we mark the 100th anniversary of this life-saving drug. Baker says insulin's story holds inspiration for today's biotech companies.

  7. A Methodology To Support Particle Investigations In Biopharma Products 11/22/2022

    Particles in parenteral products are a major cause of product recalls, and appropriate management of risk from visible particles is vital. This standardized methodology provides users with a decision-making tool to clarify the risks presented by a particle to a batch.

  8. What Is Shelf Life Testing Of A Pharmaceutical Product? 6/4/2015

    Shelf-life testing of a drug product is a means of assessing the functionality, effectiveness, and stability of a pharmaceutical product over a period of time to either establish a new expiry date for a new product, or to collect data in ongoing support of an already-existing expiry date for a commercial/marketed product.

  9. Second Chances: Repurposing Drugs For Type 2 Diabetes 3/28/2014

    Look around. Think differently. What’s old may be new again. By Erik Rocheford, study director in Discovery Research Services, Charles River

  10. The Future Of Viral Vector Manufacturing: Yield Optimization

    Ensuring optimal yield for engineered viral vectors early in a process is crucial to ensuring their eventual commercial viability and broader patient accessibility.