Newsletter | July 15, 2025

07.15.25 -- Elevate Your Biologics: Cell Line, Tox Studies, & FIH Acceleration

 

Transferring Your Cell Line With Confidence

 

CHO cells remain the gold standard for manufacturing recombinant therapeutic proteins, but new variants present challenges that could limit cell growth and product quality. These case studies highlight how expertise, experience, and robust mitigation strategies can overcome these hurdles, enabling the efficiency and reproducibility needed for success.

 

Accelerating Development With Rapid Delivery Of Toxicological Study Material

Explore key strategies and technologies designed to address the analytical considerations and material flows to facilitate the rapid delivery of toxicological material. Our approach shifts these studies earlier in the development process, mitigating potential bottlenecks and accelerating IND-enabling activities within Lonza programs.

 

Streamline Your Pathway To IND With A Rapid Tox Approach

Amid growing demand for mAbs, bispecifics, and other complex antibody-derived therapeutics, developers and CDMOs are exploring ways to ensure speed to IND and FIH studies. One approach is identifying pathways to provide material for tox studies as quickly as possible to facilitate timely IND submissions and unlock additional funding.

 

Optimizing The Progression Of Biotherapeutic Candidates To FIH Studies

This webinar shows how using the right technologies and strategies early on can help you optimize candidate selection, streamline progression to cell line development, boost manufacturability, and reduce future risks. Review common pitfalls and provide actionable strategies to quickly move your biologic candidates from late discovery to first-in-human studies.