Process Development, Supply of Pre-Clinical Materials
and Quality Control Assay Development

Our team of experts can provide comprehensive solutions and strategies for process development, quality control assay development, supply of pre-clinical and shipping studies.

Process Development and Supply of Preclinical Material

 

Our team will work together with you in assessing your current manufacturing process to identify potential improvements and create a process development strategy to meet your needs. 

We can take your process into our R&D laboratory to identify gaps and make the process more robust.

We will work with you through the entire process and assess key parameters of the process such as starting materials, raw materials, manufacturing steps and quality control assays.

As our laboratory operates to GMP, we can also manufacture and supply pre-clinical product as required for studies to enhance the development of your product.

Our services range from establishment of preclinical or research cell banks, adherent and suspension-based cell culture, media screening and selection, bioreactor process development, harvest optimisation and controlled rate cryopreservation.

Developing and Designing Quality Control Assays

 

Every product needs to be tested to assess its safety and effectiveness and the design and validation of your assay is critical for the approval of your product through regulatory bodies.

Quality Control assays (in-process controls and release assays) can be a challenge when companies are starting out and deciding what is suitable for their product. Currently, there are numerous assays available for key safety assays such as sterility, mycoplasma, and endotoxin, and knowing which assay is right for your product is critical for product development and to allow quick release of your products.

Our experience and collaborations with leading companies in the field of testing, helps you determine what tests are needed to properly evaluate your product and to ensure it is aligned to PhEur and USP regulations and that you have the optimised characterisation assays for your product.

2023 ATMP Review

The Advanced Therapeutic Medicinal Products (ATMPs) sector is evolving rapidly and new products have already demonstrated the ability to reverse or significantly impact the progression of disease. In recent years, the advent of cell and gene therapies has shown the...

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