Guest Columns

31. What To Do When Your Regulatory Findings Need Quality Risk Management Action 10/2/2024

    More than half of all recent warning letters issued by the FDA include citations for absent or incomplete risk assessments. This article examines what regulators are looking for.

32. 5 Strategic Advantages Of Manufacturing ADCs In-house 9/20/2024

    Outsourcing antibody-drug conjugate manufacturing is the status quo. This executive explains why her company chooses to do it themselves for reasons including quality control and cost management.

33. Accelerate CMC Development With Team Topologies 9/20/2024

    A method of defining role boundaries for knowledge workers in the IT industry maps nicely to CMC process development for biologics and pharmaceutical manufacturing.

34. 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.

35. FDA Issues Revised Guidance On Controlling Nitrosamine Impurities In Pharmaceuticals 9/11/2024

    The FDA has issued a revised version of its guidance, Control of Nitrosamine Impurities in Human Drugs. This article explores the agency's recommendations, root causes of nitrosamines, and strategies for mitigating their presence in pharmaceuticals.

36. Wish SUS Cost Less? Survey Says Your Peers Do, Too 9/6/2024

    BioPlan Associates 21st Annual Report found biopharma companies want lower cost single-use system options over any other new product development area.

37. A Year In, Sanofi's Journey With Plai AI Is Aiding Quality Decisions 8/30/2024

    Sanofi has been a vocal of advocate of AI/ML for years. Here's how it's using technology to facilitate the audit process and get to the bottom of deviations faster.

38. Drug Product Formulation & Process Development: The Must-Have Skills At A Glance 8/26/2024

    Specialists in drug product formulation and process development at small biopharmas need to balance scientific knowledge and multidisciplinary know-how across the stages of product development.

39. Tips For Deploying Advanced Modeling In Commercial Phase Bioprocessing 8/23/2024

    In-silico tools are ubiquitous in development, but big hurdles prevent them from showing up meaningfully in commercial manufacturing. These tips could help clear them.

40. Should You Be Using Unique Container Identification? 8/22/2024

    Unique identifiers on glass vials could solve a host of problems. ISPE developed a new guide to help manufacturers apply them on primary parenteral containers.