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GMP Manufacturing

Manufacturing of live bacterial products for vaccine and therapeutic applications according to approved manufacturing and testing instructions.

At Vibalogics, we appreciate the importance of this stage in the Investigational Medicinal Product (IMP) development cycle, which is why we have designed our operation around production of both drug substance and drug product in our facility without the need to outsource to third parties.

Live bacterial manufacturing according to GMP requires the implementation of aseptic procedures to allow for a closed-system approach to processing. Prior to manufacturing the product, Vibalogics will perform the necessary process validation via media based process runs to ensure that we can provide you with a high quality monoseptic product.

We work with defined written procedures and equipment, qualified to the appropriate standard within a monitored and controlled manufacturing environment. Our personnel are also trained and qualified prior to performing manufacturing activities to ensure the effective fulfilment of assigned tasks.

What to expect when working with Vibalogics:

  • Skilled technical transfer with man in plant, if required
  • cGMP manufacturing of drug substance and drug product
  • State of the art facility including relevant GMP manufacturing licenses
  • Capacity typical for Phase I/II clinical trials with ability to expand as required
  • Highly trained and qualified personnel backed by experienced management team
  • Qualified Persons based on-site
  • Focus on disposable production systems minimizing cross-contamination and operator risks
  • Short turnaround times
  • Comprehensive and clear documentation

To remain up to date with the latest interpretation of GMP, key personnel of our company are members of the Parenteral Drugs Association (PDA), the International Society for Pharmaceutical Engineering (ISPE) and the International Association for Pharmaceutical Technology (APV).

For a greater understanding of our facility and cGMP manufacturing capabilities, we offer a warm welcome to you to visit our facility and discuss your project on-site.

For more information regarding Bacteria GMP Manufacturing, contact us today on +49 4721 565 400 or email contact@vibalogics.com

Bacteria

Live bacterial products…

…aseptically manufactured