BioCina and NovaCina Merger Bolsters Global CDMO Industry

Global Contract Development and Manufacturing Organizations (CDMOs) BioCina and NovaCina announced a strategic merger that will create a powerful brand in biopharmaceutical and small molecule contract manufacturing. The combined company, which will retain the BioCina name, will be fully integrated to provide the market a seamless, end-to-end offering, from cell line development and process development, to clinical and commercial drug substance and sterile fill-finish of drug products. This new comprehensive suite of services positions BioCina to meet the ever-growing demand for high-quality, integrated manufacturing solutions for clients in the US, Europe, Asia, Australia, and beyond.

Mark W. Womack, Chief Executive Officer, BioCina

The merger integrates BioCina's world-class expertise in process development and manufacturing for the microbial, plasmid DNA, and mRNA modalities at the Adelaide, South Australia facility, with NovaCina's Perth, Western Australia facility, a state-of-the-art sterile fill-finish plant that has produced more than 600 biologic and small molecule products. Clients are serviced with highly experienced technical SMEs with an average tenure of more than 10 years and the synergistic union provides a streamlined, client-centric experience, managed by a single entity. Agile, phase-appropriate solutions, marked by exceptional quality, and industry-leading on-time and in-full (OTIF) delivery reliability are cornerstones for BioCina today. BioCina boasts an elite regulatory track record, including approvals from the US FDA, EMA, TGA, and Health Canada. In addition, drug developers will continue to benefit from Australia's preeminent tax incentive of up to 48.5% for CDMO programs delivered in Australia.

Mark W. Womack, who has successfully led BioCina's explosive growth and development over the last two years, will continue as CEO. Womack is long recognized for his visionary leadership, instilling a truly client-focused culture and delivering exceptionally reliable operational performance across numerous successful organizations. Previously, Womack served as Chief Executive Officer of both KBI Biopharma and Stelis Biopharma and as Chief Business Officer of AGC Biologics, where he was instrumental to their expansion.

"The cohesion of these two companies is quite ideal, and we have immense confidence in what they will achieve together, especially with Mark at the helm. The industry is rapidly transforming and becoming increasingly more complex. New drug developers along with experienced biopharma companies are looking for a trusted CDMO partner that will work hand-in-hand to drive their products to market with efficiency and streamlined regulatory approval. Each of these firms, in their own right, are superb. Together, they will boost the industry's capabilities and standards, and provide an unparalleled offering," said Masood Tayebi, Co-Founder and CEO of the Bridgewest Group, parent company of both firms.

"I am thrilled to lead this dynamic new organization. This merger solidifies our position in the industry as the most reliable and client-centric end-to-end CDMO for the global biopharmaceutical and small molecule industry," said Mark W. Womack, CEO, BioCina.

About the New BioCina

BioCina is a global end-to-end Contract Development and Manufacturing Organisation (CDMO) offering clients unparalleled quality, adherence to the highest regulatory standards, and industry-leading on-time and in-full delivery, setting a new benchmark in the industry for quality and reliability. With deep expertise in small molecules, microbial, pDNA and mRNA modalities, BioCina's comprehensive service offerings include cell line development, process development, analytical and formulation development, and cGMP clinical and commercial manufacturing.

BioCina operates two state-of-the-art facilities in Adelaide, South Australia and Perth, Western Australia. The facilities boast a rich history of developing and manufacturing clinical and commercial drug substances and drug products, backed by highly experienced Subject Matter Experts (SMEs) with an average tenure of more than 10 years.

BioCina maintains an elite quality record, meeting the highest international standards. The facilities have successfully passed regulatory inspections by the US FDA, EMA, and Health Canada, and are licensed by the Australian TGA for cGMP manufacturing of bulk drug substance and sterile drug product. BioCina has a proven track record of producing high-quality drug products distributed to 98 countries across North America, South America, Europe, Asia, and Africa.

BioCina is proud to serve clients from every major market in the global industry, and because BioCina is not a drug developer, its focus is solely on serving its clients' products.

Australia offers one of the most attractive tax incentives available globally (up to 48.5% cash refund), making it an ideal destination for drug developers looking to invest in scaling-up and manufacturing their products.

As one of the fastest growing companies in the biopharmaceutical industry across Australia, BioCina was awarded the 2024 South Australia "Emerging Business of the Year" award.