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Outsource with confidence

Partner with us and you will experience a transparent and consultative partnership. Our ethos of flexibility and open communication provides our customers with the resourceful, adaptable strategies they need to ensure projects are completed successfully, on budget and on time.

We ensure that our scientists stay informed of state-of-the-art practices in the industry, which allows us to maintain vital knowledge in the virotherapy sector. This expertise allows us to not only understand but also overcome your technical challenges.

Following a 15-year track record in virotherapy manufacturing, in May 2019, Vibalogics was acquired by Ampersand Capital Partners, a private equity firm specializing in growth equity investments in the healthcare sector.

The investment has played an important part in our growth strategy both in Europe and the United States, as we look to expand our capabilities to manufacture late-stage and commercial products in the near future.

Why not join us in Germany to inspect our facility, meet our passionate team of subject matter experts and discuss your project?

Expect open and honest collaboration. Expect exceptional quality. Experience a unique understanding of virotherapy.

Get in touch today

 

Our facility has a strong inspection and audit record from our regulatory body in Germany. We are authorized for GMP manufacturing of biological products including human and veterinary biologics, sterile and non-sterile products, liquids and lyophilizates. This means we can produce gene therapeutics, live vaccines, inactivated vaccines, recombinant products, advanced therapy medicinal products (ATMPs), in compliance with GMP requirements.

The site in Cuxhaven houses a high standard of pharmaceutical utilities, including a dedicated water for injection (WFI) system, clean steam technology and a comprehensive HVAC unit, which is backed by a fully automatic monitoring system.

Some of the key characteristics of our facility include:

 

  • 2,500 m² facility with 1,100 m² classified rooms
  • Four independent GMP production suites with 600 m² clean rooms
  • BSL- 2 laboratories for process development and GMP
  • State-of-the-art automated facility monitoring system
  • Highly purified water and Water for Injection (WFI)
  • Clean steam
  • Compressed air (free of water, oil and particles)
  • Cooling water (12/16°C, cooling capacity 800 kW)
  • HVAC (H13/14 HEPA filters) fully compliant with E.P. requirements
  • Certified Energy Management System according to DIN EN ISO 50001:2011-12

As a multi-product GMP facility we operate complete single-use manufacturing processes.

Peracetic acid cleaning validation is in place to prevent product cross-over and most of our class A/B suites are additionally fumigated with vaporized hydrogen-peroxide (VHP). Fumigation is vali-dated with biological (geobacillus stearothermophilus) and chemical indicators. Additional class C suites are in place for activities such as closed system manufacture (bioreactor suites), buff-er/media preparation and downstream processing.

For containment of GMO BSL-2 biologics we operate the suites under negative pressure in line with German law.

We regularly work with Persons-In-Plant, enabling real-time GMP observation of our processes and allowing us to problem-solve on the day, should manufacturing issues arise.

Want to know more about our facility?

Get in touch