Therapeutic antibodies are developed for the treatment of human diseases. They are the active ingredient of original drugs, prescribed to human patients for treatment of various diseases, typically cancer. They target antigens like HER2, TNFa or CD20 etc and their therapeutic function was proven in clinical trials.
Therapeutic antibodies differ from diagnostic or research antibodies because they are derived from actual drugs used for humans. Here are some characteristics that distinguish therapeutic antibodies (th-mAbs) from research-use-only antibodies (RUO-Abs): please refer to our blog entry (link).
For researchers, therapeutic molecules such as antibodies are usually difficult to obtain. At Evidentic, you can purchase therapeutic molecules and antibodies from original EU-licensed drugs as royalty-free consumables for research (RUO-only).
For customers who need different batches, we have built a stock library to offer numerous batches of the same API (active pharmaceutical ingredient). To increase the size of our library, we regularly scout the market for new batches of our in-stock drugs.
Evidentic only offers EMA-approved therapeutic molecules. The European Medicines Agency (EMA) is responsible for the scientific evaluation, supervision, and safety review of medicines for human and veterinary use in the EU.
Evidentic’s drug aliquots are produced by repackaging original drug products. Drug aliquots are therefore, small quantities of a commercial drug product that, after the repackaging process, are intended only for analytical research use and not for human use. In summary, Evidentic’s products are Research-Use-Only (RUO) products.
You may be able to find other antibodies on the market, but they will not be therapeutic, meaning that their effectiveness against human disease has not been scientifically proven. Typically, you will find antibodies on the market that have been produced from a clone similar to the original antibodies. Since the actual sequence of an expression clone is part of the patent of a drug, the vast majority of primary sequences are not published. Therefore, most RUO molecules – including antibodies – are produced on the basis of a sequence that is close to, but not identical to, the therapeutic molecule.
Furthermore, therapeutic molecules/antibodies are only a part of the final drug: the Active Pharmaceutical Ingredient (API). Forumulation of the buffer of a drug is another important component of therapeutic molecules and therapeutic antibodies. Therefore, all drug aliquots from Evidentic contain the API of the drug and other components that are critical for some analysis purposes.
After all, nowhere else will you find different batches of the same API.
The advantage of obtaining different batches of the same active ingredient is that these batches come from different manufacturing runs. Therefore, they have different biological and physiochemical properties: The active pharmaceutical ingredient (API) of each product run, i.e., the drug substance, may contain minute batch-specific variations that depend on a number of exogenous production conditions such as pH, cell culture medium, temperature, and endogenous factors including post-transcriptional and -translational modifications.
In particular, biosimilar developers ask for reference product batches from different (originator) production runs: obtaining a range of different production batches for a biocompatibility assay helps characterize these batch-specific differences.
Evidentic’s therapeutic molecules, reference drugs and therapeutic antibodies are obtained from reference products and biosimilars. Reference products are referred as reference medicinal products (RMP) in Europe or reference listed drugs (RLD) in the USA. A product has established itself as a reference product if it was the first therapeutic agent to be approved in the market via a new approval (IND) and if it enjoys patent protection for a number of years. These products later serve generic companies to use these original products as reference substances for comparative analytical investigations and as comparator drugs in clinical studies. Especially for the biotechnology industry and the biosimilar industry, RMPs serve as the most important reference source for the active pharmaceutical ingredient (API) contained in them.