(SAN DIEGO and ADELAIDE June 13, 2022) BioCina, a leading contract development and manufacturing organization (CDMO) today announced that the company has expanded its CDMO service offering to include the manufacture of plasmid DNA (pDNA) in a new dedicated GMP suite. The suite is equipped with up to 300 L single use fermentation capacity and suitably scaled downstream processing equipment. To complement GMP manufacturing, a broad range of analytical methods have been developed to support in-process, release and stability testing of pDNA products. This is a very important and timely addition that will best enable BioCina to work with its industry partners to further develop RNA vaccines and therapeutics as well as cell and gene therapies.
BioCina’s decision to expand its service offering into pDNA development and manufacturing was driven by the global increase in demand for GMP grade pDNA fueled by the exponential growth in vaccines and therapies on the RNA platform as well as strong growth in the cell and gene therapy markets. These factors, combined with the CDMO industry’s dearth of capacity and access to high-quality cGMP pDNA manufacturing expertise, made this a clear path forward underscored by BioCina's depth of experience in microbial manufacturing.
“With our extremely strong history of quality in manufacturing, an exemplary regulatory inspection history, and our customer-centric business approach, BioCina is in a strong position to add significant value to companies working in the RNA and gene and cell therapy space that are struggling to find reliable and collaborative outsourcing partners. The addition of GMP pDNA services is a natural extension of our existing traditional biologics offering and provides another avenue for growth by supporting the development and manufacturing of these innovative vaccines and therapies," said Ian Wisenberg, Chief Executive Officer of BioCina.
BioCina Chairman, Rick Hancock added “With its well established expertise in the production of microbial derived biologics, BioCina is ideally suited to address the increasing global demand for GMP plasmid DNA. Whether used as a raw material in the production of viral vectors or mRNA vaccines, or as the active ingredient for plasmid gene therapy or DNA vaccines, we look forward to partnering with innovators to assist in progressing many exciting therapies.”
BioCina Pty Ltd. is a multi-product biologics contract development and manufacturing organization (CDMO), focused on the development and cGMP manufacture of microbial-based biological pharmaceuticals, including proteins, pDNA, mRNA, vaccines and biosimilars, from early development through to commercialization. The BioCina Adelaide facility, formerly the Pfizer/Hospira plant, has a physical footprint of almost 60,000 ft2 for GMP manufacturing, process development, warehouse, and administration. The team has over 35 years of experience and extensive capabilities in microbial process development and manufacturing, with expertise from early process development to commercial manufacturing. BioCina has an enviable history manufacturing biological products approved for commercial use by the US-FDA, EMA and Health Canada, including the manufacturing of API for use in all stages of clinical trials. Licensed for GMP manufacture by the Australian Therapeutic Goods Administration (TGA), BioCina is the only GMP manufacturing facility of its kind in Australia that has successfully passsed a US-FDA inspection. BioCina is a Bridgewest Group portfolio company.