BIOCINA

HIGH QUALITY, COST EFFECTIVE MICROBIAL PDNA AND MRNA DEVELOPMENT AND CGMP MANUFACTURING SOLUTIONS

INNOVATIONS

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Adelaide

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INNOVATE™ Adelaide

BioCina Pty Ltd. is a global end-to-end biologics Contract Development and Manufacturing Organization (CDMO), focused on the development and clinical and commercial manufacture of microbial, pDNA and mRNA biological products.

BioCina’s mission is to combine world-class science with efficient and cost-effective delivery, to enable their clients to bring their therapies on time to the patients who need them.

The BioCina Adelaide facility, formerly a Pfizer/Hospira plant, includesfit for purpose spaces for GMP manufacturing, process development, warehouse, and administration, supporting clinical and commercial programs for microbial, pDNA and mRNA modalities.

The Adelaide site, approved by the FDA for commercial manufacturing in 2020, has 40+ years of manufacturing and development experience, high batch capacity for 40+ batches per year (clinical and commercial) and has cloned and expressed 60+ different microbial products.

The team has extensive experience and proven 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, and experience 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 passed a US-FDA inspection.

In 2022, BioCina expanded its CDMO service offering to include the manufacture of plasmid DNA (pDNA) in a new dedicated GMP suite, 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 was developed to support in-process, release and stability testing of pDNA products. This was a very important and timely addition that enabled 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 fuelled by the exponential growth in vaccines and therapies in the cell and gene therapy markets and RNA platform. 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.

In 2022 and 2023, BioCina was awarded a total of over $13M AUD in combined grants from the Federal Government’s Medical Research Future Fund (MRFF), Cooperative Research Centres Projects (CRC-P) and the South Australian State Government, to fund the build-out and establishment of an end-to-end mRNA process development and clinical manufacturing offering.

In terms of future growth plans, BioCina has defined a five-year growth vision, which includes adding mammalian process development and clinical commercial manufacturing capability, and large-scale biologics fill-finish.

The company’s strategic vision also includes significantly expanding its microbial scale and capacity and adding additional facilities. BioCina serves clients globally, and their portfolio already includes clients based in APAC, Europe and the United States.

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