Industry Insights

  1. The Fill/Finish Timeline: What Comes After Manufacturing 6/15/2026

    The post-manufacturing backend of sterile injectable fill-finish operates in a strict sequence—encompassing inspection, testing, QA review, and complex labeling validation—requiring early planning to avoid timeline delays.

  2. Silencing CDMO Project Noise: The Power Of Low-Drama Drug Development 3/3/2026

    Move beyond reactive firefighting by prioritizing disciplined leadership and data-driven milestones. The winning model for complex programs is focused, high-maturity, low-drama execution.

  3. Scaling Clinical To Commercial With One CDMO 5/14/2026

    Assessing whether to stay or switch CDMOs means balancing continuity benefits, capability gaps, and transfer costs to ensure efficient, low‑risk clinical‑to‑commercial progress.

  4. Does Your Pre-COVID Data Governance Pose A Threat To Data Integrity? 10/12/2020

    Pandemic disruption presents a clear and present danger to data integrity. Assessment of agreed data standards, confirmation of conformance to filed information, and general attention to details may be compromised in the rush to gather, analyze, and understand pandemic-related information.

  5. A Globally Unique Capability For Nanoforming HPAPIs

    As demand for high-potency active pharmaceutical ingredients (HPAPIs) rises, ensuring your company utilizes specialized facilities with HPAPI handling capabilities is crucial.

  6. Enabling The Outcome Through Enhancing Patient Accessibility 4/28/2025

    To ensure that the transformative potential of cell and gene therapy reaches every patient in need, we must prioritize equitable access and overcome the remaining barriers to widespread delivery.

  7. Advancing The State Of Aseptic Processing: Let's Get Serious 11/23/2020

    It seems pitiful that, for whatever reason, industry has failed to universally adopt more effective technologies to control contamination resulting in safer sterile drugs. On the other hand, the regulators must share substantial blame because of their historically lukewarm acceptance of emerging and even established advanced technologies.

  8. FDA Seeks Comment On ICH Q9(R1) Quality Risk Management 7/5/2022

    ICH has revised Q9 Quality Risk Management, providing principles and tools that can be applied throughout the product life cycle of drug substances, drug products, biological, and biotech products. The FDA, a founding member of the ICH, plays a major role in the development of ICH guidelines, which FDA then adopts and issues as guidance to industry. 

  9. Will CDMOs Commit To Fully Transparent Audits? 3/19/2019

    The first two articles in this series discussed the physical elements of facility design that sponsors look for in their CDMOs and sponsor requirements for dedicating equipment to GMP operations, equipment redundancy, and immediate disclosure of equipment and facility issues. This article presents solutions to improve transparency during sponsor audits of CDMOs.

  10. Life Sciences CIO Survey Illuminates Tech Trends 7/15/2022

    Clarkston Consulting recently conducted a CIO Market Study aiming to better understand the current priorities, challenges, and goals of upper-level information technology (IT) professionals. This article delves into the survey results of the life sciences portion of the respondents.