Ready-to-submit documentation for the USA and Europe, and now Japan
Vetter has broadened its portfolio for lyophilized substances. The contract development and manufacturing organization (CDMO) is now offering its filling service for high-quality sterile water for injection (sWFI) syringes with 5 years of stability data. Vetter’s stability data and bracketing concept allows a longer shelf life for drugs, and high flexibility while defining the filling volume. Vetter can also offer ready-to-submit documents for the sWFI service in Common Technical Document (CTD) format. This can considerably abbreviate the approval process.
Because innovative drugs are becoming increasingly more sensitive to environmental influences, they are often lyophilized to increase their shelf life. In a freeze-dried state, these drugs maintain their bioactivity for longer periods of time. However, before being administered they have to be reconstituted and dissolved in a solvent, after which they are ready for injection. The filling service for syringes with sterile water-for-injection (sWFI) is Vetter’s intelligent solution for safe and simple handling of the reconstitution process. The system contains the exact defined amount of solvent required by the customer in order to produce the required dosage. This helps to assure patients that they will receive the exact amount of substance needed.
Vetter’s filling service for sWFI syringes is an ideal complement to lyophilized drugs in vials and 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, which is designed to give a prefilled syringe system effective protection features. Vetter supports its sWFI filling service with 5 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 USA, 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 CDMO’s,” says 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.”