Claims for Patent: 7,439,349

Summary for Patent: 7,439,349

Title:	Method for preparation of large volume batches of poly-ICLC with increased biological potency; therapeutic, clinical and veterinary uses thereof
Abstract:	Method for producing large lots of final sterile Poly-ICLC suitable for clinical use with reduced toxicity at effective dose levels, and method for using Poly-ICLC to regulate genes, and method for using Poly-ICLC to treat certain human and veterinary infectious, neoplastic and autoimmune disorders.
Inventor(s):	Salazar; Andres (Washington, DC)
Assignee:
Application Number:	10/611,614
Patent Claims:	1. An improved, modified method for the production-scale manufacture of clinical grade, sterile batches of poly-ICLC, a complex of high molecular weight polyriboinosinic-polyribocytidylic acid; poly-L-lysine; and carboxymethylcellulose, having biological potency and interferon induction activity in primates, comprising the steps of adding poly-L-lysine component solution very slowly to a carboxymethylcellulose component solution over a period of at least 4 days, and mixing for the entire blending time vigorously enough to form a vortex and minimize precipitate buildup. 2. The method of claim 1, wherein the viscosity of the carboxymethylcellulose is decreased by warming to about 35 degree C., but nor more than 40 degree C. so as to allow a vortex while mixing. 3. The method of claim 1, wherein evaporation due to warming is offset by addition of sterile water for injection during the mixing process. 4. The method of claim 1 further comprising the addition of a polyriboinosinic acid component solution which is clarified by warming to about 35 degree C. prior to sterilization by filtration.

Details for Patent 7,439,349

Applicant	Tradename	Biologic Ingredient	Dosage Form	BLA	Approval Date	Patent No.	Expiredate
Merck Sharp & Dohme Corp.	ZOSTAVAX	zoster vaccine live	For Injection	125123	05/25/2006		2022-07-03