Industry Insights

  1. Emerging Market Trends For APIs 9/15/2023

    The active pharmaceutical ingredient (API) market is estimated at $158 billion in 2023 and is projected to reach $232 billion by 2028. This article shares new market research on APIs, including an analysis of innovative and generic APIs, synthetic and biotech APIs, and more.

  2. Incorporating Excipients Into QbD Studies For Drug Development — An Introduction 2/24/2021

    This article is the first in a three-part series based on information from the new guide Incorporation of Pharmaceutical Excipients into Product Development using Quality-by-Design, published by the International Pharmaceutical Excipients Council Federation. Topics covered include measuring the impact of excipient variability on finished product quality and more!

  3. How To Evaluate & Manage Safety Risks In Biopharma 5/2/2022

    Safety risks can be described and modelled as cause-and-effect relationships using system risk structures. This article structures risks beginning with a defined danger or threat so they can be effectively understood and then managed. Examples include wearing protective gloves (as a simple risk) and handling antibody-drug conjugates (as a complex risk).

  4. Drug Metabolism, Pharmacokinetics Strategies To Avoid Drug Development Mistakes Early 6/29/2022

    The right partner for your DMPK ADME needs can help you reduce compound failure, identify compounds with optimal safety profiles, and minimize drug-drug interactions in later stages.

  5. Mitigate C&G Therapy Manufacturing Risks Amplified By COVID-19 5/19/2022

    Understanding not only the limitations of a post-COVID manufacturing landscape, but also developing strategies to help overcome these challenges is critical to driving the future of next-generation CGTs.

  6. Incorporating Privacy By Design & Security By Design Into Medtech Development 9/2/2020

    Medical device companies need to act now to demonstrate their products' cyber resilience and privacy capabilities, not simply to address the myriad of compliance and data privacy regulations but also to establish patient and caregiver confidence in their products.

  7. Extending Quality Management Through Vendor Compliance Audits 5/25/2023

    Explore the primary responsibilities of both manufacturers and vendors during a vendor compliance audit, as well as practical strategies and tools, including audit management software, that make them possible.

  8. Zero-Acceptance Sampling Can Protect Your Next Data Migration 12/13/2024

    When migrating data in a GMP setting, verifying every record is impossible. A well-structured sampling approach can mitigate the risks and help with a smooth transition.

  9. 5 Things To Know About The FDA's Shift From Animal Testing 5/19/2025

    Explore how embracing advanced computational and human-relevant testing methods can transform your drug development process and accelerate your path to clinical success.

  10. mRNA-Lipid Nanoparticles Circumvent Viral Vector Limitations 6/1/2022

    Both physical and chemical nonviral gene delivery systems for ex vivo genetic modification offer advantages over viral vectors, including smaller scale production and the low risk of immunogenicity.