Advanced therapies such as gene and cell products need a particular level of experience and expertise to ensure cGMP compliance. NDA Analytics can offer you QC lot release and stability testing solutions that will help move your product forward on both a scientific and regulatory level.

We understand that undertaking lot release studies of gene and cellular products can present unique challenges and vary significantly from product to product. Physicochemical characterisation of these products differ substantially between various drugs, however the appearance, identity, purity, potency, safety and quantity of these products should still be demonstrated.

To make this possible we can offer a range of solutions which fall into three key areas:

- Assays to determine; appearance, identity, quantity, purity and impurity of your product. For advanced therapies these will include cell viability, morphology, expression of gene product, clonogenicity, cytotoxicity and quantitative assessment of all cell types including any non-therapeutic populations

- Microbiological assays to determine the microbial contamination of the product and 'in the case of live vector systems' the product titre

- In vivo and in vitro cell based bioassays to determine the potency of these therapies

The measurement of biological potency of gene and cell therapies can be varied. For gene therapies biological function must be correlated with expression of the gene product. 

There is a great deal of similarity between approaches that could be used to characterise the product and assess its functionality.

NDA Analytics' solution is to approach these assays on a case-by-case basis, working with you to provide the optimal product specific solution and helping you through the regulatory minefield and study challenges.

Click here to discuss your unique situation.