Biosimilar Manufacturing solution center

1. Sanofi's Digitalization Road Trip Shifts Into High Gear 9/16/2025

   The company's head of manufacturing discusses their latest investments in AI and automation, plus offers tips on how any company can start adopting advanced technology.

2. Why Pharmaceutical And Medical Device Risks Must Be Analyzed By Their Risk Mechanisms 9/16/2025

   Current risk analysis methods focus on the possibility and severity of bad events instead of focusing directly on analyzing and improving the performance of systems and processes producing the bad events. 

3. The Regulatory Imperative To Improve Environmental And Sustainability Stewardship In Biopharma 9/15/2025

   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.

4. How You And Your CDMO Should Leverage Contamination Control Strategies For Competitive Advantage 9/15/2025

   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.

5. What Biotech Sponsors Should Look For In A CDMO For Sterile Fill/Finish 9/11/2025

   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.

6. A Case Study In Continuous Process Verification 9/8/2025

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

7. Reliably Predicting Biologics Hotspots From Prior Knowledge 9/5/2025

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

8. When Single-Use Technology Becomes An Economic Imperative 9/3/2025

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

9. Unpacking Pfizer's Advanced Process Control Platform For Upstream Ops 8/29/2025

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

10. How AI Is Revolutionizing Quality Management Systems 8/13/2025

    The real question isn't whether pharmaceutical companies should adopt AI in their quality systems, but how to implement it effectively and what specific benefits to expect.