Industry Insights

  1. Build A Vial-Stopper Combination Suitable For Drug Product Storage At -80°C

    This study worked to determine if the chosen vial-stopper-seal combination will remain integral while frozen at -80°C, under studied conditions, when the appropriate materials, processing, and sealing conditions are applied.

  2. Considerations In Design And Development Of Novel Combination Drug-Delivery Devices 7/17/2026

    Poor scoping kills drug delivery device programs before they start. Learn how to define the right problem, assess risk early, and set boundaries that protect your timeline and budget.

  3. Sensitive Critical Starting Materials Need A 'Just-In-Data' Approach 11/14/2025

    Here's a blueprint for transforming the fragmented, high-risk interface between vector and cell therapy platforms into a unified, predictable, and compliant system.

  4. AI Has Arrived In Biotech CMC Amid Patchwork Governance 6/3/2026

    AI is surfacing within regulatory and CMC workflows at a vigorous pace. Unfortunately, in small and midsize biotechs, it's happening faster than governance can keep up.

  5. Strengthening Drug Product CMC through Drug Product Science | AAPS 4/27/2026

    At AAPS, drug product experts discuss how formulation, stability, and analytical services enable robust CMC strategies, reduce development risk, and support confident regulatory decision‑making.

  6. Navigating The Regulatory Landscape For Therapeutic Radiopharmaceuticals 1/27/2020

    There have long been numerous global and local regulations for how nuclear materials are transported, compounded, monitored, and dosed for the purpose of diagnostic evaluation. These continue to be applicable for both diagnostic and therapeutic nuclear medicines. However, establishing therapeutic medical claims for nuclear medicines increases the list of regulations that must be followed.

  7. Manufacturing Biotherapeutics Based On Synthetic Biology: Lessons Learned 7/8/2022

    In 2014, Synlogic's co-founders formed the first company that would apply the principles of synthetic biology to the creation and development of biotherapeutics. This article shares their journey in overcoming challenges in producing synthetic biotics, considering new approaches in manufacturing, and the benefits of a hybrid production model.

  8. Method Transfer – When, Why, How? 2/16/2022

    A formal method transfer is an exercise that demonstrates and documents that a method has been successfully qualified in another laboratory to provide accurate and repeatable results.

  9. 4 Preparatory Moves For A Post-COVID World 6/19/2020

    While we don’t know how different the post-COVID world will be, we do know that pharma and medtech leaders are looking ahead and planning to work differently.

  10. Building Better CDMO Supply Chain Readiness 7/28/2025

    As advanced therapies grow more complex, CDMOs must move beyond fragmented logistics and embrace integrated supply chain partnerships to ensure scalability, compliance, and long-term success.