FDA EIR - Biovex, Inc. - February 13, 2015

An FDA pre-license inspection was conducted at BioVex Inc. (Amgen Woburn) from February 10-13, 2015, under the regulatory framework for Biologics License Applications (BLA 125518) of talimogene laherparepvec (T-Vec), a product for melanoma treatment. The inspection, equivalent to a Level I assessment for somatic cell and gene therapy products, aimed to evaluate the manufacturing facility. Upon conclusion, the FDA issued a Form 483 with three observations. These included improper aseptic technique by a manufacturing operator in an ISO biological safety cabinet, specifically concerning wipe usage during cleaning and obstruction of a vent grill. Additionally, the Biosafety Cabinet Logbook for a critical area lacked documented evidence of required monthly reviews. The third observation noted that a validated process hold period for an intermediate step was not incorporated into the media fill studies. All identified issues were discussed with firm management, necessitating corrective actions to ensure compliance with good manufacturing practices ahead of product commercialization.