« Public Health

"In addition to being vital for public health, identifying the recent impurity in heparin was a chemical triumph," said Dr. Jeremy Berg, director of the National Institute of General Medical Science, which helped pay for the study. (Check http://phdig.collectivex.com/link/go/13387201 for the full text

While this is at the best is a re-affirmation of the already established fact (many including FDA, USP have already established the identity of the contaminant & established protocols for quantifying the same…) It sure does not come across as a “Chemical Triumph” as Dr. Jeremy states – rather it’s an “Analytical Tragedy” that a contaminant as large as 20% of the API was merrily getting past the Quality Control of so many capable companies worldwide!

I personally feel that the real issue now is not just Heparin, but the "Imminent Adulteration Potential of existing/ future Macromolecule Therapeutics/ Therapeutic Aids"

Given the increasing prominence of the number of biological agents used as therapeutics in the form of recombinant proteins, monoclonal antibodies, vaccines, etc & given the apparent ease with which one can come up with an engineered fake macromolecule that behaves as the ‘real’ macromolecule (as exemplified by the Heparin API case (over-sulfated Chondroitin behaving as Heparin during assay) one can arrive at a conjuncture that there potentially could be many more such cases/ probabilities even for other macromolecular therapeutics.

it is important to re-evaluate the Potency Assays of all commercially available biologics & determine if the tests are discriminatory enough when it comes to existing & potential structurally related contaminants.

I found this interesting article on AAPS website; http://www.aapsj.org/view.asp?art=aapsj0902017

It will be interesting to know if AAPS has started thinking in this direction (of evaluating all existing LBAs/ Chemical Assays/ Bioassays for their level of discrimination w.r.t. to closely related contaminants…) I see quite a few AAPS members among PhDG members – can anyone throw light on this?