Newsletter | November 18, 2021

11.18.21 -- De-Risk And Accelerate Your Drug Development

 
Scale-Up And BLA Planning For Microbial Biomanufacturing: When Should You Talk To A CDMO?
 

Ensuring early planning of scale-up and biological license application (BLA) activities for your microbial-based product can maximize your chances of success, by allowing sufficient time to develop options for launch, ultimately preventing costly delays and setbacks.

For mAbs, A Small Biotech Recognizes The Value Of Expertise And Track Record
 

William B. Jones, senior vice president of pharmaceutical development at Corvus Pharmaceuticals, discusses CDMO selection for the company’s CPI-006 antibody program, which is currently under development as an oncology drug and investigation as a therapeutic for immune disorders and infectious diseases.

What Can You Do To Overcome Immunogenicity And Immunotoxicity Assessment Challenges?
 

In addition to threatening the safety of patients, drug candidates that fail because of immunosafety issues also cost drug developers significant losses in time and money. Assessing immunogenicity and immunotoxicity potential at the earliest possible stage is critical.

Identifying And Mitigating Potential For Immunogenicity, Immunotoxicity
 

Explore the challenges of assessing the immunosafety profile when moving a drug candidate to first-in-human (FIH) studies, including key considerations and pitfalls to avoid along the way. Case studies highlight how in vitro immunotoxicity assessments add significant value by predicting risk early.