Industry Insights

31. Successfully Managing The Life Cycles Of Cell And Gene Therapies 8/8/2023

    Learn more about the right processes to utilize across the CGT life cycle and why having the right people to develop and execute those processes can ensure success.

32. 11 Critical Steps To Manage Solvents During API Manufacturing 3/5/2021

    Manufacturers and distributors use multipurpose tankers for organic solvents for the manufacturing of APIs and associated intermediates. This presents a cross-contamination risk that might go undetected when the solvent is tested before offloading into a manufacturing site distribution system. This article explores the risks and mitigation options available to API manufacturers.

33. Advancing Life Sciences Automation 9/18/2025

    Explore how Life Sciences teams are aligning digital innovation with patient outcomes through connected systems, scalable data strategies, and collaborative development.

34. The Business Case for Healthcare Compliance Programs for Emerging Companies 6/9/2023

    For emerging drug and medical device companies on a tight budget, an effective healthcare compliance program can actually save precious resources by establishing better oversight, controls, and monitoring of the company’s quality, R&D, clinical, and market access activities. Such a program should be implemented in pre-commercial stages and will prepare you for the regulated future ahead. 

35. Meeting Stability Testing Expectations In A Complex Pharma Landscape

    What was once a check-the-box procedure in standard stability testing now requires a deeper understanding of the molecule, its behavior, and what effect it has on the patient.

36. Bringing Data Quality To The CRO-BioPharma Partnership 2/10/2023

    Learn about CRO use in response to growth in pharma companies, R&D spending and activity, and rising number of drugs in preclinical trials.

37. FDA's Draft Guidance On Safety Testing Of Human Allogeneic Cells For Use In Cell-Based Therapies 5/24/2024

    This article provides a summary and analysis of the FDA's new draft guidance, Safety Testing of Human Allogeneic Cells Expanded for Use in Cell-Based Medical Products. The public comment period ends July 29.

38. Defining And Overcoming Batch Release Deviations 5/31/2024

    Agencies lack a specific definition for deviations, so it’s up to each company to clearly define what they are, and then build systems to prevent and react to them.

39. The Power Of Collaboration In Uncertain Times 7/1/2025

    In times of uncertainty, collaboration becomes a strategic advantage. Explore how leading organizations can leverage collective expertise to navigate complexity, drive innovation, and build resilience.

40. Fueling The Genetic Revolution With cGMP Manufacturing And Training 5/20/2022

    ElevateBio, in collaboration with Cytiva, is forging a path forward with a solution to de-risk the development of novel therapies, helping to speed the delivery of new CGTs and regenerative medicines.