The InnovaVector state of the art GMP facility (~500 m2), is located in Pozzuoli (Napoli, Italy).
Quality-by-Design and Risk Management were applied to the design, construction, qualification and validation of the facility.
The classified plant is designed to accommodate cutting edge disposable technology fulfilling EU cGMP requirements according our Quality System.
By the investment we are now able to expand our services thought authorization by AIFA (Italian Authority) under EMA for the production of gene therapy products for phase I and II clinical supply for CDMO clients.
Our mission is to provide solutions for AAV-vector client’s success in advanced medicines.
Our brand new facility, highly experienced scientific team with extensive past GMP background and our problem solving commitment to work closely with clients every step of the way, have helped us to build an excellent reputation in the AAV gene therapy market.
We are “one stop shop” by providing plasmid manufacturing, process development, pre-clinical and clinical manufacturing, fill and finish, processing cell line, safety testing, certificate of compliance, certificate of analysis and release for clinical trials by our own certified Qualified Person – as turn key solution.
InnovaVector’s routine documentation; plans, reports, SOPs and Batch Manufacturing Records are in English
The objective is to get the GMP facility authorized by the Italian Drug Agency (AIFA) by the end of 2022 for the manufacturing and release of AAV batches for phaseI/II clinical studies.