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Vetter’s newest clinical manufacturing site successfully completed its first customer fills

  • Written by Vetter Pharma International GmbH
Next milestone for the site development is achieved Positive feedback received from audits with more scheduledPlanned expansions will help meet increased customer demand
RAVENSBURG, GERMANY AND RANKWEIL, AUSTRIA - Media OutReach - 5 July 2022 - With the realization of the first successful customer fills, Vetter[2], a leading global Contract Development and Manufacturing Organization (CDMO), has reached another milestone at its new clinical manufacturing facility[3] in Rankweil, Austria. Further batches are already planned, and more customer projects are in the business pipeline. In addition, the site is being expanded to optimize processes and increase production capabilities.

© Vetter Pharma International GmbH: Area for material preparation at Vetter's Rankweil site.
Vetter purchased the Rankweil facility in mid-2020 to help meet growing customer demand for complex fill and finish solutions in early drug development phases and to act as the European counterpart to the company’s clinical manufacturing site near Chicago[4] in the US. Within one year of its purchase, the site was adapted and integrated to meet Vetter’s high quality standards. In December of 2021, successful completion of cGMP inspection by the responsible national regulatory authority, the Austrian Agency for Health and Food Safety[5] (AGES) was achieved thus allowing the facility to support clinical development projects of global pharmaceutical and biotech companies.

© Vetter Pharma International GmbH: Vial filling station at Vetter's Rankweil site
“We have been highly focused on achieving the strategic integration of the site,” said Dr. Martin Schwab, Site Head Austria. “With hard work and focus, we have managed to get the site fully operational quickly and are already planning for expansion and further development." In order to offer customers additional production capacities, a second autoclave and another washing machine for material preparation will be implemented in the next few months, as well as a modification of the current lyophilizer to become consistent with its Ravensburg facilities, allowing for an optimized aligning of systems and processes. This will support for instance the transition from clinical to commercial[6] production within Vetter.

Andrea Wesp, Vice President New Business Development added, "Our intent is to support global customer projects as best as we can by offering a flexible and holistic service portfolio for clinical manufacturing. The positive feedback we have received from customers so far who have already visited our Rankweil site is not only proof that we are meeting their needs but that we have achieved an important step in our business strategy."

Find the Vetter press kit and more background information here [7]

[1]

References

  1. ^ Media OutReach (www.media-outreach.com)
  2. ^ Vetter (www.vetter-pharma.com)
  3. ^ clinical manufacturing facility (www.vetter-pharma.com)
  4. ^ site near Chicago (www.vetter-pharma.com)
  5. ^ Austrian Agency for Health and Food Safety (ages.at)
  6. ^ transition from clinical to commercial (www.vetter-pharma.com)
  7. ^ here (www.vetter-pharma.com)

Authors: Vetter Pharma International GmbH

Read more https://www.media-outreach.com/news/germany/2022/07/05/145084/

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