GUEST COLUMNISTS

• Accelerate CMC Development With Team Topologies

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

• Upping Flow Of Advanced Technologies Into Commercial Biomanufacturing

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

• FDA Issues Revised Guidance On Controlling Nitrosamine Impurities In Pharmaceuticals

  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.

• Wish SUS Cost Less? Survey Says Your Peers Do, Too

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

• A Year In, Sanofi's Journey With Plai AI Is Aiding Quality Decisions

  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.

• Drug Product Formulation & Process Development: The Must-Have Skills At A Glance

  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.

• Tips For Deploying Advanced Modeling In Commercial Phase Bioprocessing

  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.