CMO Symbiosis completes gene therapy-focused FDA inspection

UK-based CMO Symbiosis Pharmaceutical Services reports that it has successfully completed its latest inspection by the U.S. FDA of its facilities in Scotland.

According to the CMO, the inspection, conducted over a seven-day period in January, focused on the ongoing fill/finish of ongoing commercial supplies of an AAV viral vector product for a long-standing client — a U.S. big pharma company. Symbiosis recorded zero GMP observations during the inspection.

The 6,300-square-foot purpose built GMP sterile manufacturing facility is located within the thriving Scottish biotech corridor. The facility boasts two GMP clean room suites, enabling filling for a range of products, including viral vectors, plasmids, mAbs, proteins, peptides, RNA and high potent APIs, including ADCs.