Industry Insights

31. 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.

32. How Approved Drugs Have Evolved Since The '70s

    Drugs have become more lipophilic and complex in structure over time. Innovative strategies are needed to improve the bioavailability of these new drugs.

33. Updated Orange Book/Biologic Patent Study: Key Learnings 10/20/2021

    Recently in 2021, the United States Patent and Trademark Office published an update to its 2019 Orange Book patent/biologic patent study report, analyzing America Invents Act post-grant proceeding outcomes for biologic patents and Orange Book‑listed patents between Sept. 16, 2012, and June 30, 2021. This article shares key learnings.

34. Medical Devices Regulatory Priorities In India 5/14/2018

    India’s Medical Device Rules, 2017 have many attractive features that encourage the medical device sector in India. They have been formulated to promote domestic manufacturing and to regulate import and manufacturing in the region. This article examines some of the regulation’s key points to provide a better understanding of its impacts.

35. Continuous Manufacturing: Many Want It, But Here's Why Few Have It 2/13/2024

    In 2023, biomanufacturers showed an increasing interest in continuous manufacturing, but uptake, believe it or not, slowed down. Let’s explore the reasons why with data from BioPlan Associates.

36. Upping Flow Of Advanced Technologies Into Commercial Biomanufacturing 9/12/2024

    A set of tools NASA developed assessing new, rapidly developed and deployed technology could help biopharmas adopt advanced tech post-commercialization.

37. Adopting A Quality Management Maturity Model In Drug Manufacturing 1/11/2023

    The objective of QMM is to elevate quality beyond the base level of cGMP. Explore practical paths to pharma QMM and the key benefits of a digital pharma QMS.

38. These Are The Top Priorities & Challenges For New CDER Director Patrizia Cavazzoni, M.D. 7/30/2021

    Recently appointed to the permanent CDER director role, Dr. Cavazzoni’s appointment was not unexpected, as she was recruited to join the FDA in 2018 from a senior industry role and served as acting CDER director at the start of the agency’s pandemic response. Her experience suggests she will continue to evolve – rather than revolutionize – FDA’s drug review policies.

39. Facts About AAV Producer Cell Lines 8/8/2025

    Gene therapies are revolutionizing medicine, with AAV vectors leading the way. As production evolves, stable cell lines may replace transient transfection and unlock scalable solutions.

40. Are There Business Benefits To Serialization Beyond Compliance? 6/18/2015

    This may seem a complex question to answer as you begin your serialization journey. It is difficult to look beyond the significant challenges that lie ahead in this undoubtedly complex project — initial funding and stakeholder engagement, vendor selection and delivery adherence,