InnoCore is a drug delivery company specialized in the development of long acting and minimally invasive injectable drug delivery products. We offer a highly versatile portfolio of proprietary biodegradable polymeric drug delivery systems and pharmaceutical development expertise to enable sustained release of any drug candidate. We have state-of-the-art facilities for polymer R&D, formulation development, analytical characterization (GMP licensed), and manufacturing activities for supply of material for up to and including non-clinical safety studies. We can transfer our processes either to a cGMP contract manufacturing partner or directly to the customer for GMP manufacturing.

R&D

Each new project starts with a feasibility study in which we apply our scientific and technological knowledge and skills to demonstrate that the drug is compatible with InnoCore’s proprietary drug delivery technologies. We offer custom solutions to your unique challenges with an array of formulation technologies to choose from. In close collaboration with our partners and customers we manage to fit the right technology with the required specifications /targets of the active pharmaceutical ingredient such as release period and dose concentrations.

GLP

Each GLP project starts with the development of a reliable and robust process for the manufacturing of formulations intended for a GLP toxicology study. For this, the R&D process is optimized using a risk-based approach by identifying the critical process and formulation parameters. The applicable methods are further developed and validated. In addition, the process is scaled-up for in-house material manufacturing up to 100 g. As part of the GLP project, pre-stability studies can be provided.

GMP

For cGMP batch manufacturing, the process is scaled-up to kilogram scale and tested for robustness and transferred either directly to the customer or a cGMP contract manufacturing partner. Aseptic manufacturing is implemented, and limited process validation is performed, and the analytical methods are validated. InnoCore is licensed by the Dutch competent authority with a GMP certificate for chemical/physical quality control testing of human investigational medicinal products. Stability studies according to the ICH guidelines are part of our service.

Why choose InnoCore?

Development and manufacturing

InnoCore has state-of-the-art facilities for polymer R&D, formulation development, analytical characterization (GMP licensed) and manufacturing activities for supply of material for up to and including non-clinical safety studies.  We can transfer our processes either to a cGMP contract manufacturing partner or directly to the customer for GMP manufacturing. Innovation is key in the services we provide to bring products from:

 

1. Exploratory feasibility

 

2. Feasibility

 

3. Optimization

 

‚Äč4. Material for non-clinical safety studies

 

5. Scale up and optimization

 

6. GMP batch

 

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