Industry Insights

  1. Revising Annex 1: A Case Study In Controlling Operating Risks By Understanding Uncertainty 11/13/2020

    Unfortunately, the pharmaceutical industry does not understand how to control a risk’s likelihood of occurrence. The current draft of EU GMP Annex 1 is an example of the industry’s focus on a risk’s severity while not understanding or evaluating a risk’s uncertainty and thus defaulting to using the precautionary principle for guidance.

  2. From Preparation To Compliance: DSCSA Implementation Takes Big Steps In 2025 5/7/2025

    The phased exemption periods of the Drug Supply Chain Security Act (DSCSA) expire on different dates throughout 2025 (including one quickly approaching in May), marking a series of milestones for implementation.

  3. Are You Still Evaluating CMOs When You Really Need A CDMO? 10/29/2025

    Outsourcing adds capacity and specialized knowledge to your supply chain. But contractors come in several types. Here's how to pick the right one.

  4. Can Your Laboratory Meet The Demands Of Today's Bioprocessing Landscape? 6/8/2020

    By adapting to today’s demands using smart bioprocessing, you can help drive efficiency in your laboratory and contribute to the economical and reliable production of next-generation molecules.

  5. The EU Biotech Act Has Been Delayed — Here's What That Means 5/7/2025

    First due at the end of 2025, the act has been delayed until late 2026, which suggests key issues that many say hobble innovation will go unaddressed for longer.

  6. Emerging Vaccine Technologies

    Rapidly shifting modalities require broad CDMO expertise and capacity, and commercializing recombinant vector vaccines requires a skill set that differs from protein or peptide based approaches.

  7. How MSAT Drives Efficient Tech Transfer

    A CDMO’s manufacturing science and technology (MSAT) plays a critical role in optimizing a biomanufacturing process to meet the needs of the modern healthcare landscape.

  8. 4 Key Solid Tumor Therapy Objectives iPSCs Can Help Achieve 4/4/2025

    Induced pluripotent stem cells offer some key biologic, technical, and financial advantages over more established PBMC-derived therapies.

  9. Filtration In Air Quality Testing 3/5/2026

    Air quality testing depends on accurate collection and analysis of particulate matter. Understanding particle size, sampling methods, and filter performance is key to generating reliable data.

  10. The Source Of GMP- How Client Demand Drives Innovation 1/13/2021

    GMP-Source, which is a term we coined, serves the purpose as a highly qualified raw material for a generation of virus, messenger RNA template, and transgenic expression of proteins.