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.
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
Identification of suitable technology
Specify target product profile
Compatibility study of compound/API and technology
Initiate/transfer analytical method & method development
2. Feasibility
Initial formulation development
Determination of release profile
Analytical method development and validation
QC testing
Define process conditions
3. Optimization
Formulation development
Process development
Qualification of analytical method
Scale up , if necessary
Qualify analytical method
Design of Experiments (DOE)
In-vitro release according to specifications
Submission of first animal trial batches
4. Material for non-clinical safety studies
Production of a batch under best clean conditions with full traceability and change/deviation management
Validation of analytical methods and QC testing
QC analyses
5. Scale up and optimization
Process scale up to desired batch size
Formulation and process optimization
Analytical method optimization & validation
Analytical method validation
Design of Experiments (DOE)
6. GMP batch
Transfer of manufacturing process to cGMP contract manufacturing partner or customer
Preparation of GMP documentation
Manufacturing of GMP batch
QC testing (InnoCore is GMP licensed to perform required analyses and validation work)
