In March 2019 we announced an agreement with the New Jersey Innovation Institute (NJII) to support its new cell and gene therapy development and manufacturing center. Two years on, BioCentriq - the brand name given to the center - has already launched a pilot development plant, completed the validation of a GMP center and opened the doors for clinical manufacturing.
The facility is equipped with a range of equipment supplied by us, including scalable single-use bioreactors that support both adherent and suspension cell cultures, and downstream processing equipment and materials for the purification and concentration of drug substance. Of particular note is the iCELLis® fixed bed bioreactor used in the manufacture of the most recent gene therapies to receive FDA approval, namely Zolgensma - Novartis’ adeno-associated virus vector-based in vivo gene therapy, for the treatment of spinal muscular atrophy (SMA).
With this equipment, BioCentriq is ready to offer process development and cGMP contract manufacturing services, but the equipment and these services meet only part of the industry's needs. To support the rapidly growing cell and gene therapy market, skills gaps also need to be closed and, in addition to the critical processing equipment, we have supported the creation and presentation of an introductory course for gene therapy at BioCentriq. To date, despite the challenges that the COVID-19 pandemic has meant, three courses providing comprehensive training to over 35 delegates have been delivered.
These skills, and the full set of services that BioCentriq aims to provide, support the industry that sowed the seeds of many of the genetic vaccines helping in the fight against COVID-19, and can leverage the advances made in the last 12 months to further accelerate the development and industrialization of the already rapidly-growing gene therapy market. These vaccines, and the corresponding increased demand for manufacturing capacity and skilled operators, also shine a spotlight on the future role that BioCentriq can play in the industry, supported by proven Pall® technology and robust manufacturing platforms.