GUEST COLUMNISTS

• The Regulatory Imperative To Improve Environmental And Sustainability Stewardship In Biopharma

  As the industry faces increasing pressure to align with environmental, social, and governance (ESG) standards, companies must evaluate how to integrate supply chain management with these initiatives to drive sustainability and mitigate risks.

• How You And Your CDMO Should Leverage Contamination Control Strategies For Competitive Advantage

  It is no longer sufficient to just meet compliance requirements; a proactive, risk-based approach to contamination control is now a differentiating factor that enhances operational efficiency and more. For biotech companies evaluating CDMOs, this shift is critical.

• 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.

• 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.

• 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."

• When Single-Use Technology Becomes An Economic Imperative

  Industry changes increasingly favor SUT for novel products, even while stainless steel remains an essential part of many process trains.

• Unpacking Pfizer's Advanced Process Control Platform For Upstream Ops

  Pfizer's advanced process control platform gives modelers more dexterity compared to default controllers, thus speeding up process development.