Clinical-grade molecules are molecules that have been produced with clinical quality. The term Therapeutic means that the molecule had its efficacy and safety proved to the treatment of human diseases (through clinical trials). These molecules are the active ingredient of original drugs, prescribed to human patients for treatment of various diseases. The molecules commercialised by us have these two attributes: they are clinical-grade and therapeutic.
They differ from research-grade molecules because they are derived from actual drugs approved for humans. 
For research purposes, clinical-grade molecules such as antibodies are usually difficult to obtain. From us you can purchase clinical-grade antibodies and other biologics from original EU-licensed drugs as royalty-free research consumables (RUO-only). For customers who require different batches (from different manufacturing runs), 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 search the market for new batches of our in-stock drugs.
Evidentic only offers EMA-approved therapeutic molecules. EMA is responsible for the scientific evaluation, supervision, and safety review of medicines for human and veterinary use in the EU. *EMA (European Medicines Agency), FDA (Food and Drug Administration)

Evidentic’s drug aliquots can be used for analytical, in vitro and in vivo research, typically executed in early drug development stage of drug discovery programs.

As examples we can mentioned:

  • Use as reference molecules for your assays
  • In functional in-vitro and in-vivo assays
  • For analytical procedures
  • For biosimilar and new drug early development
  • To compare against your research-grade molecules
Typically, you will find antibodies on the market that have been produced from a clone similar to the original product. Since the actual sequence of an expression clone is part of the patent of a drug, most primary sequences are not published. Therefore, most research-grade molecules – including antibodies – are produced based on a sequence that is close to, but not identical to the therapeutic molecule. Furthermore, clinical-grade molecules are only a part of the final drug: the Active Pharmaceutical Ingredient (API). Formulation of the drug’s buffer is another important component of these molecules. Therefore, all drug aliquots from Evidentic contain the original formulation of the original drug (API and buffer of the original drug, in original concentration).
The advantage of obtaining different batches of the same reference product is that these batches come from different manufacturing runs. Therefore, they have slightly 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 several exogenous production conditions such as pH, cell culture medium, temperature, and endogenous factors including post-transcriptional and translational modifications.
In particular, biosimilar developers usually require different batches of the reference product from different manufacturing runs: obtaining a range of different production batches for biocomparability assays helps characterize these batch-specific differences. You know that is virtually impossible to source different batches of the same reference product at the same time using the regular sourcing channels.
Reference products are called 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 – Investigational New Drug) and if it has patent protection for a number of years. For biotechnology and biosimilar industry, RMPs are the reference source for the active pharmaceutical ingredient (API) contained in them.

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