HJB and Mabspace Biosciences' Development and Manufacturing Agreement for Novel Humanized Claudin18.2 Monoclonal Antibody Accomplished FDA and NMPA IND Clearance
HANGZHOU, China, May 8, 2020 /PRNewswire/ -- HJB, a biologics CDMO committed to quality, reliability and speed for each and every CMC package delivered to its partners, today announces that its partner Mabspace Biosciences has received Investigational New Drug (IND) clearance from both the U.S. Food and Drug Administration (FDA) and China National Medical Products Administration (NMPA), for a humanized Claudin18.2 monoclonal antibody program.
Per the development and manufacturing agreement between HJB and Mabspace Bioscience, HJB provided one-stop shop end-to-end CMC package for the Claudin18.2 antibody, from DNA synthesis, process development, DS and DP GMP manufacturing to CMC dossier preparation for IND.
"We are thrilled to have achieved dual-filing in such a short time. This is truly a great milestone for us," said Dr. Xueming Qian, Founder and Chief Executive Officer of MabSpace Biosciences. "HJB's one-of-a-kind platform not only allowed us a speedy IND submission and clearance, but also added more values to our program. We are very excited to have the opportunity to test this differentiated Claudin18.2 antibody in cancer patients and bring more efficacious treatment options to cancer patients around the world."
"Congratulations to Mabspace Bioscience for the dual-IND clearance. We are proud to be the CMC and manufacturing partner to enable this accelerated and high-quality development package," said Dr. Jerry Yang, General Manager of CDMO Business of HJB. "It is fundamental to our CDMO business to create values for our partners. In this case, our efficient and innovative development and manufacturing platform successfully shortened the total program time and further increased the molecule's biological activity independent of molecule engineering which is typically how other companies approach the challenge and often leads to freedom-to-operate limitations later on."
HJB's platform approach was proven highly adaptable and robust during this program. After receiving DNA sequence in September 2018, HJB significantly increased this antibody's ADCC activity through process optimization, delivered GLP toxicology study material in 9 months and completed all CMC work required for FDA and NMPA filing in 14 months. The result dramatically accelerated the overall timeline and allowed the program to reach first-in-human milestone with high quality Phase I clinical material ahead of other competitors.
Since its facility's first GMP run in mid-2018, HJB has taken on over 20 CDMO projects, delivered 15 batches of GMP products and been recognized by its global partners for quality, reliability and speed. Currently, HJB's comprehensive capabilities include cell line and cell bank development, process and formulation development, technology transfer and optimization as well as GMP manufacturing, with three DS production lines (500 - 2000L) and a DP fill-and-finish line.
HJB is dedicated to significantly accelerating process development and reducing manufacturing cost through technological innovations including continuous manufacturing, providing high quality, reliable and efficient CDMO services to partners. With an R&D Center and GMP Manufacturing Facility in Hangzhou, China and business presence in the U.S, HJB has provided comprehensive services including Cell Line Development, Process Development, Analytical and Formulation Development, Quality Assurance, Stability Study, Clinical Sample Manufacturing and Regulatory Support to domestic and international partners. For more information, please visit http://www.hjbbio.com/.
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