Symbiosis Pharmaceutical Services completed its latest inspection by the FDA of its facilities in Scotland. Headquartered in Stirling, U.K., and specializing in the manufacture and fill/finish of pharmaceuticals and biopharmaceuticals for clinical trials and the supply of commercial markets, the CDMO recorded zero GMP observations from the FDA during the inspection in January.
The FDA inspection was conducted over a seven-day period and focused on the ongoing fill/finish of commercial supplies of an AAV viral vector biologics product for a U.S. pharma client. The inspection outcome validated Symbiosis’s robust quality management systems, ensures continued adherence to FDA regulations, and reinforces the capability of Symbiosis to deliver high-quality biopharmaceutical sterile manufacturing solutions globally, according to Colin MacKay, CEO of Symbiosis.
“In a rapidly evolving biopharmaceutical landscape, regulatory rigor and GMP operational performance are enduring priorities for the company and a fundamental part of our business and cultural ethos,” said MacKay.
The company continues its physical and operational expansion with the commissioning of its new automated sterile GMP manufacturing facility, close to its existing facilities in Stirling. This will increase the company’s commercial-scale sterile manufacturing capabilities, enabling it to support a growing number of clients globally through the clinical and commercial injectable drug product lifecycle challenges, continued MacKay.
Separately, Enzene, an India-headquartered CDMO working with fully-connected continuous biologics manufacturing technology, said that its two facilities in Pune, India, have received European Union (EU) GMP certification to provide commercial-scale microbial and mammalian drug substance supply and drug product fill/finish and packaging.
“The European Union’s GMP certification provides existing and potential customers with tangible evidence that Enzene meets the stringent quality and safety standards required by the European Medicines Agency and marks another step on Enzene’s journey to providing comprehensive solutions to clients in Europe and beyond,” according to an Enzene spokesperson.
Enzene officials also say facilities provide fully integrated services to address the market for challenging diseases and innovative treatments. Pune was also the first site in the company’s network to feature Enzene’s modular EnzeneX™ 2.0 platform, which reduces the equipment footprint compared with that of conventional fed-batch systems.
The platform is capable of clinical phase cGMP supply from as low as 30-L scale, with variable bioreactor capacity to accommodate scale-on and scale-out expansion, reported the company spokesperson, who added that Enzene will soon launch a new $50-million manufacturing facility in Hopewell, NJ, introducing the company’s patented fully-connected continuous manufacturing (FCCM™) platform to the United States.