10.12.26 -- Speeding Therapies To The Clinic

Microbial development for first‑in‑human studies requires coordinated cell line, fermentation, and purification strategies to accelerate timelines while controlling cost and process robustness.

What does it take to make sure performance and compliance in GMP manufacturing? We optimize systems across upstream and downstream processes, ensuring they perform reliably under GMP conditions.

Our facility offers 220,000 sq. ft. of end-to-end services, including R&D, formulation development, clinical and commercial manufacturing, packaging, and advanced analytical capabilities.

Learn how the Mobile Minor spray dryer enables formulation screening, particle engineering, and process optimization through controlled spray drying for early-stage pharmaceutical development.

With patient lives depending on every dose, even minor vulnerabilities in containment or delivery systems can have serious consequences for product integrity and patient outcomes.

Is AI REALLY revolutionizing outsourced drug manufacturing, or are we still sorting useful tools from industry hype? In this episode of The Outsourcing Advisor, Bikash Chatterjee, President and Chief Science Officer of Pharmatech Associates and a member of the Outsourced Pharma Editorial Board, joins us for a fast-paced game of “AI Hype, Help, or Hazard?” He puts real-world use cases to the test, from CDMO selection and tech transfer to manufacturing, regulatory work, supply chain decisions, and partner oversight, to see where AI is delivering value today and where sponsors should still proceed with caution.

Selecting an expression system early in biotherapeutic development depends on molecular complexity, glycosylation requirements, and other structural characteristics that differ across platforms.