Revakinagene taroretcel (Encelto), the only FDA-approved MacTel therapy, slowed photoreceptor loss by up to 54.8% vs sham in phase 3 trials.
|Articles|October 2, 2015
- BioPharm International-10-15-2015
- Volume 2015 eBook
- Issue 2
Aseptic Processing for Cytotherapy, Regenerative Medicine, and Tissue-Engineered Products
Author(s)Mamoru Kokubo, James E. Akers
Isolators offer a safety and economic advantage for next-generation regenerative medicine products.
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BioPharm International
eBooks Volume 28, Issue 14
Manufacturing advanced biologics demands solutions that are quite different from what is being used for large-scale industrial biologics processing today. This article touches on approaches that work with advanced biologics. Read this article and other articles in
BioPharm International
's 2015
eBook.
Articles in this issue
about 11 years ago
Fluctuating Capacity and Demand Conditions in Biomanufacturingabout 11 years ago
Cleaning Validation for Biologicsabout 11 years ago
Automation of Single-Use Systemsabout 11 years ago
Are Biopharma Patents Poised on the Post-Grant Chopping Block?about 11 years ago
Raising the Bar for Biopharma TrainingAdvertisement
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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.
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.
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.
Nuravax will test AV-1959R in a 160-adult phase 2 trial to see whether the amyloid vaccine can prevent Alzheimer disease before symptoms begin.
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