Industry Insights

  1. The BPCIA And Declaratory Judgment: The Real Dance Partners? 2/17/2021

    In theory, the initial exchange process in the first phase of litigation is intended to whittle down the number of patents and initiate resolution of any disputes during FDA review of the aBLA. However, despite its high-minded objectives, litigation under the BPCIA has proven less harmonious than planned. 

  2. Shaping Biotherapeutics Development Programs Around Different CMC Paths

    As protein engineering and manufacturing technologies evolve, there's a need for flexible, customized strategies to accelerate drug development and approval of biotherapeutics.

  3. 5 Ways For Emerging Biotechs To Launch Smarter 4/20/2022

    Biotechs with less than $1B in total sales represent a significant share of new molecular entity market approvals and launches, growing from 10% in 2017 to 30% in 2021. Small and midsize biotech valuations are thus rising, making them less attractive for acquisition and forcing them to launch on their own. These 5 launch strategies can bolster the odds of success.

  4. Improving Viral Safety: Highlights Of ICH Q5A(R2), USP, Ph. Eur. Recommendations 8/6/2024

    ICH Q5A (R2) was released in Nov. 2023 and adopted by the FDA and EMA earlier this year. For a fuller assessment of viral control, compendia from the USP and European Pharmacopeia help.

  5. Leveraging AI And Data Science For Biologics Characterization 9/12/2025

    Modern analytical tools produce more data than we know what do with. Artificial intelligence helps condense, interpret, and utilize what's most meaningful.

  6. The Role Of FDA Predicate Rules In 21 CFR Part 11 Compliance 7/8/2022

    Explore the relationship between FDA predicate rules and GMP, GLP, GCP, or other requirements applicable to your organization. 

  7. Customer Spotlight: Queen Mary University Of London's Centre For Predictive In Vitro Models 5/10/2024

    Discover the future of in vitro modeling at the Queen Mary+Emulate Organs-on-Chips Centre and unlock new possibilities in the field of predictive medicine.

  8. Scaling Personalized Medicines For Flexible Aseptic Filling 2/14/2024

    Traditional aseptic filling solutions can introduce contamination and variability. Learn about Cytiva's commitment to finding innovative solutions and improving patient outcomes in the field of medicine.

  9. Overcoming Barriers: Protein Degraders Tackle Neurodegenerative Diseases 5/27/2025

    New therapies aim to dismantle disease-causing proteins in neurodegeneration. What key challenges must these innovative molecules conquer to become effective treatments?

  10. Draft Q&A Guidance Offers Roadmap For Biosimilar Post-approval Changes 7/31/2024

    FDA explains how it's looking to evaluate the effects changes might have on biosimilar products' identity, strength, quality, purity, and potency.