First cGMP-certified manufacturing facility commissioned to manufacture bacteriophage products for human use
San Diego and Richmond, VA, USA, Ljubljana, Slovenia, and Sydney, Australia, June 3, 2014 – AmpliPhi BioSciences Corporation. (OTCQB: APHB), a global leader in developing bacteriophage-based antibacterial therapies to treat drug resistant infections, announced today that its production facility in Ljubljana, Slovenia, was cleared by JAZMP, the Agency of the Republic of Slovenia for Medicinal Products and Medical Devices, to manufacture bacteriophages under current Good Manufacturing Practices (cGMP) standards. AmpliPhi will produce Staphylococcus aureus and Pseudomonas aeruginosa bacteriophages to be used in planned human clinical trials.
“This clearance is a pivotal regulatory milestone that further supports AmpliPhi’s leadership in the field of bacteriophage with the only cGMP-certified manufacturing facility in the world dedicated to producing bacteriophage products for human use,” said M. Scott Salka, CEO of AmpliPhi. “In addition, this clearance allows us to advance our proprietary clinical program and validates our technology platform for a broad range of bacteriophage therapeutic applications and collaborations.”
AmpliPhi commissioned its production facility in early 2014 after conducting a comprehensive evaluation of global manufacturing options. The Company ultimately realized the benefits of having its own dedicated facility, enabling more stringent control over its manufacturing operations and eliminating the need for relying on contract manufacturing. The 600-square-meter facility includes clean areas of various grades (A-D), optimized to meet the particular needs of each step in the manufacturing process and designed to comply with cGMP standards. The Company has already produced Master Cell Banks (MCBs), Working Cell Banks (WCBs), Master Viral Seeds (MVSs) and drug substance (DS) from S. aureus bacteria and phages, which were selected from extensive in-house libraries on the basis of strict criteria, resulting in pure, reproducible, high quality and cost-effective therapeutic preparations.
“The certification of our manufacturing facility is an important corporate accomplishment allowing the company to supply drug candidates for our upcoming clinical trials,” said Mr. Salka.
About AmpliPhi BioSciences
AmpliPhi BioSciences Corporation (OTCQB: APHB) is a biotechnology company focused on the development and commercialization of novel bacteriophage-based antibacterial therapeutics. The Company's product development programs target infections that are often resistant to existing antibiotic treatments. AmpliPhi is collaborating with a number of leading organizations, including Intrexon Corporation (NYSE:XON), the U.S. Army, The Royal Brompton Clinic in London and The University of Leicester, UK to rapidly advance bacteriophage-based therapies.
For more information, visit www.ampliphibio.com.
Bacteriophage are naturally occurring viruses that are highly specific for the bacterial hosts they infect. They can rapidly kill their host, amplifying themselves in the process. Bacteriophage are unaffected by antibiotic resistance and are able to disrupt bacterial biofilms. Such biofilms are a major line of defence for bacteria, contributing to antibiotic resistance. Bacteriophage are able to penetrate biofilms and replicate locally to high levels, to produce strong local therapeutic effects.
Forward Looking Statements
Statements in this press release about AmpliPhi’s manufacturing capabilities and ability to manufacture pure, reproducible, high quality, cost effective human preparations, the potential use of bacteriophages to treat bacterial infections, including infections in biofilms and infections that do not respond to antibiotics, and the development of bacteriophage-based therapies are forward looking statements subject to risks and uncertainties, including without limitation the risk that the Company will not be able to successfully manufacture sufficient quantities of products to conduct clinical trials or commercialize products in a timely manner or at all, that AmpliPhi may not commence clinical trials or complete IND-enabling studies as expected, that the clinical trials will not be successful, that further development of the Company's products will require extensive and expensive nonclinical and clinical testing, may not be safe or efficacious, and may not be approved for marketing by the United States Food and Drug Administration or any foreign regulatory agency. For a further description of the risks and uncertainties that could cause actual results to differ from those expressed in these forward-looking statements, as well as risks relating to AmpliPhi's business in general, see AmpliPhi's Annual Report on Form 10-K for the fiscal year ended December 31, 2014, as amended, filed with the Securities and Exchange Commission (SEC) on April 15, 2015.
Issued for and on behalf of AmpliPhi Biosciences by Instinctif Partners.
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