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

Chief Scientific Officer Jon Lenn discusses the balance of art and science in topical formulation development, emphasizing advanced skin models for optimized delivery, activity, and product stability.

Achieving compliance and safety through Disinfectant Efficacy Studies (DES) is about adhering to regulations and committing to high standards of safety and quality of manufacturing operations.

With increased pressure on CMC development to support shortened BLA submission timelines, mass spectrometry (MS) can be leveraged to accelerate and de-risk product and process development.

There's a need for continuous innovation to develop life-saving drugs and therapies. Explore the key outcomes of embracing Pharma 4.0 — and how they ladder up to drive critical business strategies.

Discover how our process development team resolved a racemization challenge by delivering a biologically active racemic mixture while maintaining compound purity.

Uncover how early planning of medium, feed systems, and manufacturing workflow can mitigate costs, reduce delays, and accelerate therapeutic delivery to patients.

Learn how modifying the micro-environment with targeted excipients can significantly enhance the dissolution rate of poorly soluble drugs using conventional manufacturing methods.

Review a semi-automated method for dynamically assessing plunger migration under controlled variations in temperature and pressure, utilizing computer vision tools.

When developing a nasal delivery program, a partner with experience in development and manufacturing techniques who can see a program through small-scale clinical to commercial supply is crucial.

A new algorithm developed by a real-time viable particle counter determines the viability of a particle based on its measured optical properties, improving the detection of microorganisms.

The dynamic growth and pace of change observed in novel mAb formats and cell and gene therapies emphasizes that biomanufacturing innovation is essential to deliver scale, speed, and sustainability.

A pharmaceutical company facing storage space issues decided to outsource its reference samples to Q1 Scientific, a stability storage service provider, resulting in cost savings.