GUEST COLUMNISTS

• What Biotech Sponsors Should Look For In A CDMO For Sterile Fill/Finish

  Choosing the right CDMO partner for a biotech product isn’t about “capacity at a good price”; it’s about a partner with the right mix of technical expertise, regulatory track record, and more.

• How AbbVie's Digital Transformation Brought Platform Knowledge Closer

  A custom-built digital ecosystem reduced the time spent on documentation in AbbVie's bioprocess development labs by about 70% for some experiment types.

• The New FDA Era Of Radical Transparency And Pervasive Oversight

  The first half of 2025 has been transformative for biopharmaceutical quality and regulatory affairs, with the FDA leading the charge with four significant changes. Curadian Group's David Grote discusses implications for all four.

• A Case Study In Continuous Process Verification

  CPV can strengthen the bridge between compliance and continuous improvement. In this scenario, a hypothetical lab sets out to improve process yields and efficiency.

• Optimizing Lentiviral Vectors For Allogeneic CAR-T Manufacturing

  A group of graduate researchers explored VSV-G affinity chromatography as an alternative to the standard anion exchange chromatography or AEX.

• Reliably Predicting Biologics Hotspots From Prior Knowledge

  Site-specific post translational modifications can seriously affect a molecules stability, function, and structure. These modifications are commonly called "hotspots."

• Contract Manufacturing Outsourcing Trends For Advanced Therapies In 2025 And Beyond

  Contract manufacturing continues to emerge as the widely adopted model for bringing cell therapies, gene therapies, RNA therapeutics, and oligonucleotides to patients worldwide.

• Building The Biopharma Manufacturing Facility Of The Future Requires A Phased IT/OT Strategy

  Your pharma or biotech company can take these actionable steps to achieve digital facility operations and successfully build your own facility of the future.