Newark-based BioCentriq has completed the construction of a state-of-the-art GMP-ready clinical manufacturing facility in South Brunswick. The new facility is adjacent to its existing pilot plant and includes all the supporting infrastructure and lab space to support the clinical manufacturing of allogeneic and autologous cell therapies and gene therapies.
Due to the COVID-19 pandemic, much of the industry’s manufacturing capacity has been re-directed to vaccine production. These capacity constraints are occurring at a time when the industry is experiencing exponential growth in the development of personalized medicines.
According to the Alliance of Regenerative Medicine, as of Q3 2021 there were more than 2,261 ongoing clinical trials and market research firms regularly estimate compounded annual growth rates (CAGR) greater than 20%.
“This expansion of our clinical production capacity allows us to meet the demands of our clients,” stated Haro Hartounian, senior vice president and general manager of BioCentriq. “We understand the myriad of challenges our clients face when they are optimizing and scaling up their processes to prepare for clinical manufacturing. Our team’s cumulative expertise in process development and GMP manufacturing enables us to meet the growing demand in this space.”
“There are three things that make BioCentriq unique and very attractive to small and mid-size therapy developers” said Hartounian. “First, we embrace a hybrid project team model, welcoming and encouraging our clients to work alongside our scientists and engineers to transfer and optimize their processes and help prepare for manufacturing. Second, we are equipment agnostic and willing and able to bring in whatever equipment and technology is needed, often acting as a test bed for innovative and emerging systems. Lastly, we have no interest in acquiring any of our client’s intellectual property and we do not impose ours on them.”
BioCentriq™ is a cell & gene therapy process development and clinical manufacturing center founded in 2019. The company produces autologous and allogeneic cell therapies and gene therapies, and immunotherapies, including monoclonal antibodies and proteins, and vaccines on behalf of therapy developers. BioCentriq™ also acts a test bed for emerging technologies and equipment providers and offers customized workforce development programs.
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