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2590 Sheridan Garden Drive , Unit# 3, Oakville, ON, L6J 7R2, CA
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.
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.
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.
The set of four models are designed to support biopharmaceutical companies across all key stages of protein CMC development.
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