Shilpa CDMO's $50 million plan adds 10 kL of SPPS reactor capacity in Raichur, India, with its first commercial peptide line opening in December 2026.
|Articles|February 5, 2016
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Today’s BioPharm Brief covers FDA’s final potency assurance guidance for cell and gene therapies, Lonza’s deal to acquire Merck KGaA’s US CDMO business, and Phase 2a data for Tiziana’s intranasal anti-CD3 antibody foralumab in progressive multiple sclerosis.
At AAPS PharmSci 360 2026, University of Iowa PhD candidate Siddhanth Hejmady explains how adding a payload or radiolabel to trastuzumab changes its behavior in bulk solution and at interfaces, and why developability teams should pair DLS with QCM-D.
Final FDA guidance replaces 2011 potency testing advice, asking CGT makers to build potency assurance from IND filing through postmarket monitoring.
Teva will commercialize etanercept-ykro (Eticovo) and infliximab-abda, adding 2 TNF inhibitor biosimilars to US options for inflammatory diseases.
In the Phase 2a INFORM-MS trial, Tiziana’s nasal foralumab reduced microglial activation on PET imaging at 50 µg in non-active secondary progressive MS, while the 100-µg dose showed no significant effect.
The deal adds five US sites and about 1,100 employees, more than doubling Lonza’s US network and filling a gap in US bioconjugation capacity the company flagged weeks earlier.
CAR-T transformed blood cancer care, but solid and brain tumors demand different delivery, manufacturing, and safety strategies to work.
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