text: 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.
  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.
  A method of defining role boundaries for knowledge workers in the IT industry maps nicely to CMC process development for biologics and pharmaceutical manufacturing.
  A set of tools NASA developed assessing new, rapidly developed and deployed technology could help biopharmas adopt advanced tech post-commercialization.
  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.
  BioPlan Associates 21st Annual Report found biopharma companies want lower cost single-use system options over any other new product development area.
  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.
  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.
  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.
  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.