Aurealis Pharma: Development and Tech Transfer of a Live Biotherapeutic Product (LBP)
NIZO’s expertise in genetic engineering of Lactococcus Lactis using NIZO’s NICE system and its fermentation expertise in lactic acid bacteria helped Aurealis Pharma.
Aurealis Pharma came to NIZO in 2013 for the development of its proprietary technology, which utilizes genetically modulated lactococcus lactis bacteria that are able to in situ express a variety of therapeutic proteins in the diseased human chronic wound tissue, thus modulating the local immune system and enabling wound healing. These Live Biotherapeutic Products potentially offer sufferers of diabetic ulcers and cancer a much-improved, safer, and more cost-effective treatment option.
After the non-GMP upscaling, NIZO transferred the technology to a Contract Manufacturing Organization (CMO) for GMP production. The efficacy of its lead candidate AUP-16 for wound healing is currently produced under GMP conditions at SynCo Bio Partners and planned to be tested in clinical trials in 2018.
NIZO has developed the proprietary NICE system for overexpression of proteins in the food grade bacterium Lactococcus lactis. This system allows for tightly controlled expression of proteins using the food grade inducer peptide nisin. This system can be used as a safe platform for expression of proteins that have a potential to be used as biotherapeutics.
NIZO genetic engineering platform and Tech Transfer
NIZO has been involved in the full strain development pipeline, from the initial genetic construction of the strains, towards the optimization of fermentation (medium composition, fermentation conditions and DSP) on both laboratory and 30L scale.
SynCo Bio Partners was established early on in the process as the contract manufacturing organization (CMO) for the GMP productions for the clinical trials. Discussions involving all three parties enabled NIZO to perform and optimize their fermentation process by aligning to conditions relevant for the ultimate GMP production at SynCo Bio Partners. Once the 30L scale process had been optimized at NIZO, the strains, protocols and responsibilities were transferred to SynCo Bio Partners.
Aurealis Pharma is a Basel, Switzerland and Kuopio, Finland based privately-held biopharmaceutical company focusing on developing broadly applicable technology to re-educate the distorted host immune microenvironment in chronic inflammation and cancer to its proper state. Company’s technology is based on safe food grade lactic acid bacteria delivering multiple human therapeutic proteins in target tissue effectively, safely and economically to address the unmet medical need in chronic wounds and cancer.
SynCo Bio Partners B.V. is a world leading GMP contract manufacturer, focused to support its customers with clinical and commercial supply of microbial drug substance manufacturing (live microbial biotherapeutics, vaccines, proteins and polysaccharides) and aseptic fill and lyophilization of a wide variety of biologics. As a truly global player, SynCo offers support to companies worldwide in the range of small (virtual) biotech to large pharmaceutical organizations in development and manufacturing microbial based products.