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2590 Sheridan Garden Drive , Unit# 3, Oakville, ON, L6J 7R2, CA
Successfully tech-transferred and manufactured first commercial-scale GMP batches of Renaissance Pharma’s lead candidate, Daretabart.
By: Kristin Brooks
The facility becomes the 18th in WuXi Biologics’ global network.
By: Patrick Lavery
Combines direct RNA sequencing, machine learning, and automated analysis to simplify GMP.
By: Charlie Sternberg
ProtaGene’s expertise in advanced protein characterization and early-stage drug product characterization is complemented by MilliporeSigma’s GMP testing capabilities and global regulatory experience.
Aim to expand GMP testing capabilities and help ensure that safe, compliant products reach patients more efficiently.
The comprehensive on-site inspection was conducted April 14.
The partnership will work to advance Novelty Nobility’s bispecific antibody drug candidate through process development and GMP manufacturing.
Offers a scalable platform from small process development batches to larger cGMP manufacturing runs.
Plans for GMP release for production by the end of 2026.
New infrastructure aims to support clients as they advance from late-stage clinical CMC development through commercialization and post-approval life cycle management.
Released By Stevanato Group
Practical guidance for sponsors to extract meaningful insight—and avoid costly surprises— when vetting CDMO partners.
By: Michael Spangler, Tobi Williams
Site has produced hundreds of distinct bioconjugates and supports clinical, commercial, and non‑GMP manufacturing activities.
The new manufacturing facility is now fully operational and prepared to support late-stage and commercial viral vector programs at scale.
GelMEDIX gains access to Catalent’s proprietary, off-the-shelf, GMP-compliant iPSC lines and Catalent’s GMP iPSC and iPSC-derived cell therapy manufacturing capabilities.
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