PacificGMP and ArmaGen Announce Successful Manufacture of ArmaGen's investigational enzyme replacement therapies, AGT-182 and AGT-181, for Phase 1 Clinical Trial
SAN DIEGO, March 10, 2015 /PRNewswire/ -- ArmaGen Technologies (Calabasas, CA), a privately held biotechnology company focused on developing revolutionary therapies to treat severe neurological disorders and PacificGMP (San Diego, California), the leader in single-use bioprocessing for development and manufacturing for its client partners today announced the successful completion of large scale cGMP manufacture for ArmaGen's two lead drug candidates to treat lysosomal storage disorders: AGT-182 an enzyme replacement therapy targeting Hunter's syndrome and AGT-181 targeting Hurler's syndrome.
In partnership with ArmaGen scientists, PacificGMP developed and scaled up a large scale continuous perfusion production and purification process resulting in clinical manufacturing batches of 2200L and 6000L for AGT-181 and AGT-182 respectively.
In collaboration with Shire plc, ArmaGen's AGT-182 has entered clinical trials after submission of an IND application to the US FDA. AGT-181 is poised to start clinical trials in 2015.
"We at PacificGMP have had the privilege of working with ArmaGen for a number of years and so are intimately familiar with the importance of their breakthrough technology. Being able to utilize PacificGMP's expertise to assist in getting AGT-181 and AGT-182, both antibody-enzyme constructs, to the clinic is very gratifying," said Gary Pierce, CEO of PacificGMP.
"PacificGMP was able to successfully develop, scale up and perform highly challenging, complex large scale processes in a remarkably short period of time, enabling ArmaGen to move into the clinic quickly and efficiently. We look forward to continuing our relationship," said Dr. James Callaway, CEO of ArmaGen.
ArmaGen's proprietary technology platform fuses a therapeutic to an antibody that binds to the specific receptors that deliver insulin or transferrin to the brain, enabling the fusion protein to travel through the Blood Brain Barrier (BBB) in a process known as receptor-mediated transcytosis. ArmaGen's platform is unique as it targets multiple antibody-based receptor-mediated transporters advancing treatments of neurological disorders as well as neurodegenerative diseases.
PacificGMP is a US-based full-service biopharmaceutical contract development and manufacturing organization and has extensive experience in the production of both clinical and marketed products in the biotechnology sector. PacificGMP has manufactured nearly 40 unique products for use in Phase I and Phase II human clinical trials in the US, the EU and other sites.
About ArmaGen Technologies, Inc.
ArmaGen is a privately-held biotechnology company focused on developing revolutionary therapies for severe neurological disorders. The company is developing a robust pipeline of innovative therapies for the treatment of neurological complications of lysosomal storage disorders such as Hunter syndrome, Hurler syndrome, metachromatic leukodystrophy and Sanfilippo A syndrome, as well as central nervous system diseases such as Alzheimer's and Parkinson's. ArmaGen's pipeline is based on decades of scientific leadership in engineering therapies to cross the BBB and a dominant intellectual property portfolio. The company is advancing its pipeline through licensing and collaboration agreements, in-house development programs, and future partnering opportunities. For more information, visit www.armagen.com.
About PacificGMP, Inc.
PacificGMP is a contract manufacturer and industry leader in single-use technology for development and manufacturing of biologics. Single-use technology eliminates the risk of cross-contamination, has fewer system requirements and significantly reduces the time required to initiate production. Benefits to clients include rapid project turnaround and the most cost effective solution in the industry. PacificGMP partners with drug developers by providing a range of cGMP and non-GMP services from cell line optimization, early process design, development and scale-up, to preclinical and clinical manufacturing, aseptic filling, analytical services and regulatory support. More information can be found by visiting the company's website at www.pacificgmp.com.
CONTACT: Carol Shaw, [email protected]
SOURCE PacificGMP
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