title: Stability of BCG vaccine (intravesical) Theracys/BCG therapeutic ImmuCyst and its importance in clinical efficacy.
abstract: The manufacture of Therapeutic BCG can and should be a controlled process, to ensure adequate treatment doses are received by CIS patients. Standardization of production methods and CFU potency testing methods are essential to ensure continued successful treatment of CIS. Stability data can be used to validate assumptions about Therapeutic BCG potency used in clinical trials. Accelerated heat degradation studies of Therapeutic BCG should not be used for predictions of shelf life, but can be used for comparative purposes.
authors.affiliation: Connaught Laboratories Limited, Willowdale, Ontario, Canada.
authors.forename: J
authors.initials: J
authors.lastname: Sparkes
authors.forename: N
authors.initials: N
authors.lastname: Guest
authors.forename: Z
authors.initials: Z
authors.lastname: Csizer
authors.forename: L
authors.initials: L
authors.lastname: Barreto
mesh_terms: D000283:Administration, Intravesical; D001500:BCG Vaccine / Q000592:standards* / Q000627:therapeutic use; D001431:Bacteriological Techniques; D002278:Carcinoma in Situ / Q000188:drug therapy / Q000628:therapy; D004317:Doxorubicin / Q000627:therapeutic use; D004355:Drug Stability; D006801:Humans; D009163:Mycobacterium bovis / Q000254:growth & development; D011309:Preservation, Biological; D012074:Remission Induction; D013696:Temperature; D013997:Time Factors; D001749:Urinary Bladder Neoplasms / Q000188:drug therapy / Q000628:therapy
chemical_list: D001500:BCG Vaccine; D004317:Doxorubicin