Vetter has expanded its portfolio for lyophilized substances, offering its filling service for high-quality sterile water for injection (sWFI) syringes with five years of stability data. According to the company, its stability data and bracketing concept allow a longer shelf life for drugs and flexibility defining the filling volume. Vetter also offers ready-to-submit documents for the sWFI service in Common Technical Document (CTD) format. According to the company, the sWFI filling system offers safe handling of the reconstitution process and contains the exact defined amount of solvent required by the customer to produce the required dosage.
Vetter’s filling service for sWFI syringes is available in 1.5 ml formats with a volume of 0.5 ml to 1.3 ml, as well as a 3 ml format with a volume of 1.4 ml to 3.0 ml. The syringe features Vetter’s V-OVS tamper-evident closure. The company supports its sWFI filling service with five years of stability data and can manufacture batches of up to 120,000 / 140,000 pieces. For the sWFI syringes, Vetter has ICH-compliant and ready-to-submit documentation for the U.S., Europe, and Japan. Validation and stability data according to USP, Ph.Eur., Ph.J., and ICH guidelines are also available.
“Lyophilized drugs are an international growth segment for CDMOs,” said Peter Soelkner, managing director of Vetter. "An ever greater number of manufacturers are looking for options to enable a safe and simple administration of these drugs. Our filling service for WFI syringes represents a reliable and patient-friendly solution offering our customers high-flexibility due to Vetter’s bracketing concept, and fast time-to-market by using the ready-to-submit documents. In addition to documents for approval in the USA and Europe, we also have all the necessary documentation for Japan available for pharmaceutical and biotech firms, which can considerably abridge the approval process.”