NDA Analytics has over twenty years experience working with large molecules, and in that time we have created an extremely well organised and customer focussed team of experts that are on hand to understand your large molecule needs.

Our QC lot release and stability testing is cGMP compliant, and we have worked with a wide variety of biopharmaceuticals including monoclonal antibodies, recombinant proteins, enzymes, peptides and oligonucleotides. 

Our diversity extends into a myriad of therapeutic areas including oncology, metabolic disease, inflammation, autoimmunity, cardiovascular and respiratory disease. No matter what biopharmaceutical type or therapeutic area we can offer you the right package to move your product forward.

Our service offering falls into three key areas:

- Physicochemical assays to determine the appearance, identity, quantity, purity and impurity of your drug

- Assays to determine microbiological safety

- In vivo and in vitro cell based bioassays to determine the potency of your drug

Measurement of biological potency is one of your most important considerations when undertaking QC lot release of biopharmaceuticals,  for clinical trials or commercial supply. 

To ensure your product moves through the compliance pathway smoothly these assays require increasingly stringent validation criteria the closer the product gets to market. Most biological potency assays are product-specific and require extensive scientific understanding of the nature of the product in order to design the most appropriate strategy.

There are three main approaches to potency testing for your biopharmaceutical:

- In vivo (animal) testing where a physiological response to drug intervention is measured

- In vitro (cell based) assays that measure a biological response to a drug, examples of this include cytotoxicity, proliferation, intra and extracellular signalling, cell migration and cell activation. A wide range of cell biology techniques are used to measure these endpoints

- A limited number of biopharmaceuticals, including enzyme replacement therapies employ biochemical assays to establish potency, although this approach does not always lend itself to some of the more complex drugs

NDA Analytics does not only offer you the services you require to tick the regulatory boxes, but has the experience and expertise to help you plan and successfully overcome potential developmental obstacles in an ever changing landscape.

Click here to discuss your individual requirements.