06.16.22 -- Key Considerations In Early-Stage Biopharma Financing

Sterilization, process control, and validation issues at drug manufacturers have all generated FDA warning letters for concerns that include inadequate aseptic processing operations, human error, high endotoxin levels, microbial contamination, and insufficient sterility testing.

You may have questions or knowledge gaps on technology transfers. To help your understanding, we’ve compiled a beginner’s guide to technology transfer fundamentals.

Explore the further development of a two-step purification of a bispecific antibody (bsAb) in a collaborative study to develop a downstream process.

Before you sign on the dotted line, do a little digging to unearth potential costs that could turn your development program into a cash-burning exercise.

See a quick visual summary of findings from an early feasibility clinical study featuring a 2-5 mL wearable injector with a viscous placebo.