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GMP Manufacturing

Manufacturing of vaccines, gene and oncolytic viral therapies performed for human and veterinary clinical products.

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.

We work with defined written procedures and equipment, qualified to the appropriate standard within a monitored and controlled manufacturing environment.  Our personnel are always trained and qualified prior to performing manufacturing activities to ensure the fulfilment of assigned tasks. We save time and ensure that a seamless transition between Process Development and GMP activities occurs by avoiding the need for internal process technology transfer.

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).

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

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 Virus GMP Manufacturing, contact us today on +49 4721 565 400 or email contact@vibalogics.com

Egg Based Virus

Egg based virus production…

…using Specific Pathogen Free (SPF) or production eggs