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The comprehensive on-site inspection was conducted April 14.
By: Patrick Lavery
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.
By: Charlie Sternberg
Plans for GMP release for production by the end of 2026.
Released By Stevanato Group
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.
Collaboration links cell line development and GMP manufacturing to help biotechs reach IND milestones faster.
By: Tim Wright
This submission follows the successful completion of aseptic process simulation validation batches executed under the requirements of the revised EU GMP Annex 1 requirements.
Site provides process R&D, analytical and stability testing, cGMP API manufacturing, and CMC support.
By: Kristin Brooks
Enhances its ability to serve regulated European markets while adhering to globally benchmarked quality and compliance standards.
Issues Material Qualification Certificate for GMP Grade ELAREM cell culture media.
Authorization clears the way for customers to enter Brazil’s $40 billion pharmaceutical market.
To evaluate the potential for applying GMP-ready robotic systems to commercial-scale cell therapy manufacturing.
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