Each project for the manufacturing of material for non-clinical safety studies starts with the development of a reliable and robust process for the manufacturing of formulations intended for a non-clinical safety study e.g. GLP toxicology study (the non-clinical safety studies are not performed by InnoCore). For this, the R&D process is optimized using a risk-based approach by identifying the critical process and formulation parameters. In addition, the process is scaled-up for in-house material manufacturing up to 100 g which will be provided to the customer or a third party for pre-clinical and toxicity studies. The analytical methods needed for release testing are further optimized or developed for which InnoCore uses a phase-appropriated method validation approach with compliance to (international) high quality standards. As part of the project, pre-stability studies can be provided.

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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