Industry Insights

  1. It's Time To Dethrone CHO When It Comes To mAb Production 2/1/2024

    Let’s be honest — CHO is an expensive, inefficient, and pervasive way to make mAbs. Emerging and evolving alternatives discussed here include microbial systems, which tend toward better efficiency.

  2. Clinical Trials In The Era Of Precision Medicine: What Needs To Change? 7/11/2019

    Part 1 of this two-part article examined the implications the transition to value-based, patient-centric, precision medicine has for drug discovery, development, and deployment, particularly for clinical trials. Part 2 explores precision medicine in more depth regarding the tailored and targeted treatments that aim to match patients to medicines according to particular clinical, demographic, and lifestyle factors.

  3. Need To Improve Your Change Management? Regulators Can Help With That 1/12/2024

    The path to successful change management in drug manufacturing can be pocked with bottlenecks. Here are some tactics you can use to avoid them.

  4. Unlocking Potential: A Deep Dive Into AAV Development And Manufacturing 7/9/2024

    When it comes to furthering AAV's potential in the wider biopharmaceutical pipeline, partnering with a CDMO that can foment an optimal analytical and manufacturing strategy is crucial.

  5. Building Quality Into Everything We Do – From A To Z 7/7/2022

    By having better control over our manufacturing processes we are able to minimize the risk of out-of-specification intermediates all the way through to final products.

  6. How Biopharma Can Address Specialized Skills Gaps And Improve Resilience

    Learn how professional training and education programs combined with advanced digital learning technology are key to training local talent and securing biomanufacturing resilience.

  7. These Were FDA's Top Citation Issues For Data Quality In 2024 1/31/2025

    Pharma, biopharma, and medical device makers should watch out for these perennial problems, which include inadequate procedural controls and poor record-keeping.

  8. 6 Drug Discovery Learnings From The Lab 10/5/2022

    With more than 25 years of experience, this author shares insights from the perspective of bench science that pertain to experimental design and data generation. These concepts apply not only to individual experiments but also more broadly.

  9. 6 Reasons To Choose Altasciences As Your CDMO Partner 1/9/2024

    Whether you're initiating preclinical safety testing or commencing Phase 1 clinical trials, Altasciences’ manufacturing services can support you from formulation through to commercialization.

  10. How To Avoid Warning Letters For Data Integrity Nonconformances In Life Sciences 11/10/2022

    Data integrity is established where the data is stored and managed in its original form. Discover why the FDA expects manufacturers to ensure all data meets the guidelines outlined in the ALCOA acronym.