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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 practises 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 and vaccine 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, and enabled us to build a new 110,000 sq. ft. late-stage clinical and commercial manufacturing facility in Boxborough, MA, which will be operational by the end of 2021.

With this new facility, we will be able to support our customers across the clinical and commercial journey and provide routine supply, alongside our boosted fill and finish capacity.

We will be able to easily tech transfer our customers’ products from our early phase manufacturing facility in Germany to the U.S., resulting in a complete end-to-end service from pre-clinical to commercial supply. Moreover, located near Boston, MA – one of the world’s leading pharmaceutical research hubs – the site will benefit from local talent and expertise, enabling us to enhance the support we offer customers.

Why not get in touch to learn more about our facilities, get acquainted with 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.

Leadership team

Vibalogics’ leadership team has decades of experience in the virotherapy space, and is committed to delivering an unrivalled service to customers. Together, the team is building a world-leading viral vector specialist CDMO, offering innovative technology and capabilities, with the flexibility and adaptability to grow with customers.

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