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.
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.