Industry Insights

31. Biosimilars: Lessons Learned From Regulatory Approvals 12/9/2019

    The EU has approved 16 biological molecules, and the U.S. has licensed the same molecules (including approving some as 505(b)(2) approvals), except for follitropin alfa, which amounts to 114 biosimilars, combined. This article, based on the EMA’s European public assessment reports (EPARs) and the FDA’s BLA (biologics license application) reviews, identifies many inconsistencies that require revision of regulatory guidance to assure faster approval of biosimilars.

32. WHO's 6 Principles For An AI Regulatory Framework For Medical Product Development 12/14/2023

    In mid-Oct. 2023, the WHO published a paper titled Regulatory Considerations on Artificial Intelligence for Health, identifying the key principles that international regulatory frameworks for artificial intelligence (AI) should address and are, in fact, starting to coalesce around. The paper was developed in consultation with a WHO Working Group whose members include regulatory authorities, policy makers, and more.

33. Tech Due Diligence: Acquiring A Biopharma Manufacturing Facility 4/8/2022

    As a consultant, this author has been approached on several occasions to perform on-site technical due diligence for facilities that his clients were considering to acquire. In this article, he shares the considerations you should keep in mind when acquiring a stand-alone biopharma manufacturing facility.

34. Closing The MES Value Gap: Why Technology Isn't The Problem 5/14/2026

    Manufacturing execution system (MES) technical maturity is rising, but adoption across manufacturing sites is uneven. Organizational readiness may hold the key.

35. 5 Foundations Of Lean Leadership For Pharmaceutical & Medical Device Professionals 7/2/2021

    Every life sciences company, now more than ever before, is on a journey to provide greater returns to stakeholders by manufacturing products at better quality and lower cost, which is the aim of lean manufacturing. However, many people forget about the cultural and leadership aspects of lean, which at its foundation are responsible for the success or failure of a lean transformation. 

36. Oral Solid Dosage Formulation And Process Development: A Case Study 12/4/2024

    This case study involves a drug substance currently in the preclinical phase. Discussion includes API physical chemical characteristics, enabling technologies, formulation assessment, and more.

37. The New EMA Protect ADR Database 3/26/2013

    On February 18, 2013 the EMA released a new Adverse Drug Reaction (ADR) database. By Bart Cobert

38. Overcoming Commissioning Challenges To Achieve Operational Readiness 10/19/2023

    As the data center market continues to grow exponentially, third-party testing and commissioning have become vital to achieving operational readiness on time and within budget.

39. Supporting AAV And Lentiviral Vector Development And Commercialization 1/12/2021

    Plasmids are essential for the development of viral vectors used to manufacture novel gene therapies and viral vaccines. We are supporting the innovation of drug developers in this space by providing standardized royalty-free, bulk AAV helper and lentiviral packaging plasmids for research and GMP production.

40. Active Versus Passive Shipping Solutions For Clinical Shipments 2/13/2026

    Explore active and passive temperature-controlled shipping solutions and their impact on clinical trial supply, balancing cost, risk, and product integrity.