Patent ID: 8378072

Claim:
A process for manufacturing a composition comprising directed sequence polymers (DSPs), comprising the steps of: (1) selecting a first base peptide sequence, wherein the sequence is an amino acid sequence of an epitope of an antigen associated with an autoimmune disease; (2) synthesizing by solid phase peptide synthesis a first cassette of the DSPs, each cassette having a sequence of amino acid positions corresponding to each amino acid of the base peptide sequence, wherein, for at least one amino acid position of the first cassette of the directed sequence polymers, an amino acid is added, said amino acid randomly selected from a mixture of amino acids comprising the original amino acid found at that amino acid position, alanine (A), and, optionally, at least one conserved substitution, wherein the amino acids in the mixture are present in a fixed molar input ratio relative to each other, determined prior to starting synthesis, wherein the relative molar amount of A is more than 10% and less than 90% of the total amino acid concentration of the DSPs; (3) optionally extending the length of the DSPs by at least one of (a) repeating step (2) for 2 to 15 cycles and elongating the DSP under the same condition; or (b) repeating step (2) for 2 to 15 cycles and elongating the DSP, for each cycle, using a different input ratio of amino acids in the mixture; or (c) repeating steps (1) and (2) for 2 to 15 cycles and elongating the DSP using cassettes based on more than one base peptide; or (d) assembling 2 to 15 cassettes synthesized in a single cycle of step (2); or (e) assembling 2 to 15 cassettes, the first cassette synthesized under one condition of step (2), and second and more cassettes synthesized under other conditions of step (2); (4) optionally further elongating the DSPs by repeating steps (2) and (3) for 2 to 15 cycles, wherein for each cycle a new cassette of the DSP is designed independently from any of the previous cassettes designated by previous cycles of step (2); wherein the number of cycles selected in steps (3) and (4) is selected so that the final length of the DSP is about 25 to 300 amino acid residues.