BioPharm Weekly News Roundup—Week of Nov. 10, 2025

Welcome to the BioPharm International® weekly news roundup for the week of Nov. 10, 2025. In this video feature, the editors highlight each week’s industry news in an easy-to-consume, fun format. New roundups will drop every Friday, so be sure to come back each week. And be sure to check the links below for more in-depth coverage of each story.

Early-stage biologics formulation stability requires an orbital shaker model using 2R vials to reliably assess and prevent protein aggregation, according to Siddhant Sojitra of Alexion Pharmaceuticals.

Chiesi’s partnership with Aliada Therapeutics for the latter’s blood-brain barrier-crossing platform technology will allow Chiesi to develop and commercialize enzyme replacement therapies to address lysosomal storage disorders in the central nervous system.

Researchers have established an optimized agitation stress-testing model showing how mechanical forces influence stability in high-concentration biologics, enabling more reliable early-stage formulation assessment and quality prediction.

Advanced pharmacokinetic/toxicokinetic protocols using strategic contract research organization partnerships are essential to strengthening data integrity and ensuring regulatory compliance in non-clinical drug development, according to Sara Underwood of Alturas Analytics.

Biologic commercialization requires phase-appropriate characterization and timely method qualification starting at the investigational new drug amendment stage to prevent regulatory delays with biologics license applications, according to KBI Biopharma’s Kelly Donovan.

Automating clinical bioanalysis via technology-first laboratory execution systems enhances manufacturing scalability and compliance and drastically reduces drug development timeline setbacks, according to Dash Bio’s Ely Porter.

FDA’s new plausible mechanism pathway accelerates individualized therapy approval for ultra-rare diseases, demanding unique manufacturing strategies and post-market monitoring.