CMOs Gear Up for Biologics Manufacturing Challenges

Zylidac will test whether optogenetic cell lines that hit 21 g/L in small-scale CHO runs can deliver higher-yield complex biologics at GMP scale.

Rohit Tripathi, vice president of industry strategy, consumer packaged goods, and manufacturing at RELEX Solutions, explains what is driving biopharma reshoring, how USMCA uncertainty complicates sourcing for biologics, and where cold-chain visibility still breaks down.

Backed by €400 million (US$449 million) in EU-cleared German aid, the new Frankfurt facility is designed to secure insulin supply for people with diabetes from 2032.

Nathan Edwards of Arya Consulting moderates a discussion with Elisabeth Gardiner of Tevard Biosciences and Donny Xu of the RTW Institute about rare disease treatment development and navigating the FDA’s Rare Pediatric Disease Priority Review Voucher Program.

Rohit Tripathi, vice president of industry strategy, consumer packaged goods, and manufacturing at RELEX Solutions, explains where cold-chain planning still breaks down and why biopharma supply chain leaders should use AI to act on data sooner, with humans making the final call.

Revakinagene taroretcel (Encelto), the only FDA-approved MacTel therapy, slowed photoreceptor loss by up to 54.8% vs sham in phase 3 trials.

EA2251, the 7th registrational trial of ivonescimab, will test it plus chemotherapy vs pembrolizumab or durvalumab regimens in first-line BTC.

Inhaled EXO-CD24 kept 85% of patients with ARDS free of respiratory failure at day 7 vs 33.3% with placebo in a 90-patient phase 2b trial.