Biotech Values

[zipjet]

MNTA - the concept of "sameness" applied to Copaxone.

Paragraph 11 of the label:

11 DESCRIPTION
COPAXONE is the brand name for glatiramer acetate (formerly known ascopolymer-1). Glatiramer acetate, the active ingredient of COPAXONE, consists of the acetate salts of synthetic polypeptides, containing four naturally occurring amino acids: L-glutamic acid, L-alanine, L-tyrosine, and L-lysine with an average molar fraction of 0.141, 0.427, 0.095, and 0.338, respectively. The average molecular weight of glatiramer acetate is 5,000 – 9,000 daltons. Glatiramer acetate is identified by specific antibodies.
Chemically, glatiramer acetate is designated L-glutamic acid polymer with L-alanine, L-lysine and L-tyrosine, acetate (salt). Its structural formula is:
(Glu, Ala, Lys, Tyr)
x
•xCH3COOH
(C5H9NO4
•C3H7NO2
•C6H14N2O2
•C9H11NO3
(
x
•xC2H4O2
CAS - 147245-92-9
COPAXONE is a clear, colorless to slightly yellow, sterile, nonpyrogenic solution for subcutaneous injection. Each 1 mL of solution contains 20 mg of glatiramer acetate and 40 mg of mannitol. The pH range of the solution is approximately 5.5 to
7.0. The biological activity of COPAXONE is determined by its ability to block the induction of experimental autoimmune encephalomyelitis (EAE) in mice.

Link to the label since some of that does not copy well:

http://www.sharedsolutions.com/pdfs/PrescribingInformation.aspx

=====================

A few things strike me. The four components of Copaxone are specified to one tenth of one percent by molar fraction. (Accounting for 100.1% - so some rounding error.)

I would expect that to generate a given average molecular weight. But the label does not give an average molecular weight but a range for 5,000 to 9,000 Daltons.

I would also have thought that precise quantities of components in solution would have a certain pH. But rather than a pH, we are told that the pH is "approximately 5.5 to 7.0".

Perhaps my understanding of chemistry is faulty. But this suggests to me that Copaxone is not a precise composition but rather an approximation that falls into a range.

This plays to MNTA's strength, which is not only to duplicate but to do so with controls that assure greater precision in the output than the innovators are able to produce.

BTW - Chemistry is not my thing so feel free to correct me if I have fundamentally erred.


ij