GUEST COLUMNISTS

• China’s Rising Role On The Global Stage In The Oncology Market

  The oncology pharma market has largely been dominated by European and U.S. companies. With the ongoing expansion of the Chinese biopharma sector, innovative oncology drugs will emerge from China and compete on the international market.

• GMP Plant Uniform Lockers And Procedures: Best Practices

  As the use of GMP plant uniforms has gained acceptance, locker room layouts have arisen across companies and sites. This article examines alternatives and optimized approaches.

• A Deeper Look At What's Driving Dependence On Biotech Contract Manufacturers

  Are you struggling to find CDMO capacity? Here are some of the drivers behind the contract manufacturing market's exponential growth.

• Developing A Process Performance Qualification Master Plan For Gene Therapies

  This article provides considerations and a framework for a Process Performance Qualification Master Plan in the gene therapy industry. It is useful for sponsors with any level of experience.

• The EU’s Ban On TiO₂ In Food May Impact Pharma. Here’s What You Should Know.

  Titanium dioxide (TiO₂) is used as a food additive and OSD pharmaceutical excipient. In 2020, the European Food Safety Authority noted data gaps regarding particle size, which can affect its toxicological properties, so the European Commission banned it as a food additive. Here's how this could impact pharma.

• What Time Is Best To Bring My CDMO On Board?

  The answer might be sooner than you think and entail more transparency than you're used to.

• Cell & Gene Therapies: An Overview Of FDA Regulatory Considerations For 2024

  This article outlines key FDA regulatory developments from the past few months relevant to sponsors seeking approval of cell and gene therapies in the U.S.

• Innovating Bioequivalence: A Novel Approach To Developing Complex Generic Dosage Forms

  Achieving bioequivalence for complex generics is an intricate task. This article describes an approach using in vitro–in vivo correlation, PBMK modeling, and more.