GUEST COLUMNISTS

• Computer Systems Validation Pitfalls, Part 1: Methodology Violations

  When computer systems validation work is not performed according to protocol instructions — by cutting corners on quality outputs with the focus on profit as the main driver — this can result in drug and device companies losing profits and efficiencies.

• Sterility Assurance: The Fundamentals

  Sterility assurance is a critical aspect of the production of drugs and medical devices. This article covers the fundamentals, including the key components of an effective sterility assurance program.

• Expert Voices: Why Aren't QC Labs Fully Automated Yet?

  Leading automation experts chime in on why QC labs, otherwise ideal for robotics, have been slow to adopt and standardize the technology.

• What To Do When Your Regulatory Findings Need Quality Risk Management Action

  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.

• 5 Strategic Advantages Of Manufacturing ADCs In-house

  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.

• 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.