DEVELOPMENT OF SPECIFIC IMMUNOASSAY CRITICAL REAGENTS FOR PHARMACOKINETIC ASSESSMENTS OF PEPTIDE POLYMERS IN PRECLINICAL AND CLINICAL MATRICES

摘要

The present disclosure provides methods of developing a specific immunoassay for the Pharmacokinetic assessments of peptides, peptide oligomer and polymer including Glatiramer Acetate (GA), also known as Copolymer 1, Copolymer-1, Cop 1 or Cop in the clinical and preclinical matrices.

主权项

1. A method of producing and obtaining high affinity antibodies against glatiramer acetate (GA), said method comprising:
a. immunizing a mammal with glatiramer acetate to elicit an immune response for production of antibodies against GA, b. collecting serum from the immunized mammal comprising the produced antibodies at predetermined time after immunization and passing the serum comprising the antibodies through a Protein A column for purifying the produced antibodies to obtain a first pool of anti-GA antibodies, c. Preparing an anti-GA antibody column and passing GA through the anti-GA antibody column of obtain a pool of unbound GA antigen; and d. re-immunizing the mammal with the unbound GA antigen to obtain second pool of anti-GA antibodies; e. optionally repeating the cycle comprising step b. to step d. to obtain pool of enriched antibodies that has high affinity and specificity to glatiramer acetate.