Vetter to Begin GMP Filling Following Full Validation
The new commercial filling line at Vetter’s Ravensburg, Germany facility has received full validation and is prepped to begin current good manufacturing practice (cGMP) filling, following the successful media-fill completion.
A Managing Director of the contract development and manufacturing organization (CDMO), Peter Soelkner, said in a press statement “Vetter continues to expand its prefilled-syringe capabilities due to increased customer demand.”
He continued, adding Vetter was now able to accommodate the needs of customers, whether “small-batch clinical fills or high-volume commercial fills,” in its line which is currently capable of filling 1ml standard-format syringes.
Amongst the offerings of Vetter’s new systems are a number of techniques to maximize API yield. These include: Shortening distances between the compounding and filling areas, fully automating syringe closures (using a 3D scanner prior to filling) to minimize API loss and reduce contamination risk, and using an automatic weighing system to ensure exact filling quantities.
Vetter has said it already has one customer project underway, with a number of others to follow. The company would not divulge who the client was.
In 2011, Vetter inked a deal with West Pharmaceuticals in which West’s Crystal Zenith non-glass device – produced in conjunction with Daikyo Seiko, Japanese manufacturers - would be filled at the Ravensburg site. The joint venture was in response to safety issues with pre-filled syringes on the market at the time and on-going stress on cGMPs and pharmaceutical practices.
FDA Inspection
This boost for Vetter comes just a fortnight after the company’s newest facility – an 18,000m2 warehouse for both cold-storage and room temperature products – received its first approval of GMP by the US Food and Drug Administration (FDA), following an inspection in mid-March.
The facility which opened last May also at the Ravensburg location was described at the time by Managing Director, Thomas Otto, as a fundamental part of Vetter’s worldwide system. The site has already been granted European cGMP accreditation and approved for manufacturing.
