For cGMP batch manufacturing, the process is scaled-up up to 1000 g and tested for its robustness. Aseptic manufacturing is implemented and limited process validation is performed and the analytical methods are validated. Dedicated production and QC documentation is laid down with compliance to (international) high quality standards for which InnoCore is licensed by the Dutch competent authority with a GMP certificate: a European manufacturer’s authorization for chemical/physical quality control testing of human investigational medicinal products. Stability studies according to the ICH guidelines are part of our service.

InnoCore’s infrastructure enables support of partners not only during the first feasibility phase, but also during all subsequent product development phases, all the way up to manufacturing and supply of animal trial and clinical trial (GMP) batches and technology transfer if required. Regulatory support and quality assurance form an integral part of the product development services.

Over the past years, InnoCore has gathered extensive pre-clinical (including animal trials) data, allowing for an efficient and fast product development track. This in turn helps us realize, together with our partners, clinical trials in a timely manner.

 

Benefits of partnering with InnoCore

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