News
Comparability protocols ease changes "Specified" biologies already have the benefits of the elimination of lot release and the establishment of license application {Anal. Chem. 1996, 68, 674 A-677 A). Now comparability protocols can be added to that list. The option of providing these comparability protocols to the U.S. Food and Drug Administration is part of the agency's continuing effort to fulfill the "reinventing government" initiatives of the Clinton administration. Comparability testing is intended to assess the impact of a production change on the product. The goal is to demonstrate that the product made after a production change is equivalent to the product made before the change.
Depending on the extent of the change, comparability may be demonstrated through physicochemical analysis, biological assays, pharmacokinetic and pharmacodynamic (PK/PD) studies in animals, or PK/PD studies in humans. Companies would like to avoid the last option if at all possible, because it amounts to another set of clinical trials. At the third symposium on the analysis of well-characterized biotechnology products, held in Washington DC in January 1999 Greg Blank of Genentech presented the results of the comparability testifier his compeiny performed for the drug Rituxan This testing T170C tlfV % -
essary when changes made in the site of manufacture the working cell bank the cell culture medium the purification resins and the product specifications In addition the change in manufacturing sites involved
scaleup from 2750 to 12,000 L. To demonstrate product comparability, they used a battery of tests that included peptide mapping with MS, ion-exchange chromatography/MS, carbohydrate profiling, cell-based assays, sodium dodecylsulfate-polyacrylamide gel electrophoresis, and size-exclusion chromatography. Because the phase III clinical trials had been performed using product manufactured at the first site the comparability testing represented a post-licensure study. The option of submitting comparability protocols became available to companies following publication in the Federal Register on July 24,1997, of afinalrule on changes to an approved application (Fed. Regist. 1997, 62,39889-903). According to an FDA representative, companies have submitted comparability protocols that are being reviewed.
PEOPLE
Beckman receives NAS honor Arnold O. Beckman, the founder of Beckman Instruments, has been selected to receive the Public Welfare Medal from the National Academy of Sciences (NAS). This award is considered the highest honor bestowed by NAS. The announcement of Beckman's selection said that he was chosen for "his leadership in developing analytical instrumentation and for his deep and abiding concern for the vitality of the nation's scientific enterprise". Beckman received his bachelor's degree in chemical engineering and his master's degree in physical chemistry from the University of Illinois in 1922. He received his Ph.D. in photochemistry in 1928 from the California Institute of Technology, where he also served as a professor from 1928 to 1940. In 1935, Beckman invented the "acidimeter", which was used to measure the acidity of lemon juice at a southern California citrus processing plant, and founded the company that eventually became Beckman Instru174 A
ments. The invention, now better known as a pH meter, earned him a spot in the National Inventors Hall of Fame. He left the Caltech faculty in 1940 to devote himself to the company full time. The award, which consists of a bronze medal and an illuminated scroll, will be presented to Beckman during the NAS annual meeting in April. The Public Welfare Medal was established in 1914 and is presented annually to honor "extraordinary use of science for the public good".
SACP starter grant award The Society for Analytical Chemists of Pittsburgh (SACP) is soliciting nominations for the 1999 starter grant. One grant of $20,000 will be awarded to an assistant professor in analytical chemistry to encourage high-quality innovative research by young faculty and to promote the training and development of graduate students. Assistant professors who have accepted a faculty appointment at a U.S. college or university since Dec. 31,1995, are eligible. Application forms are available from Art Byers, Starter Grant Committee, Society for Analytical Chemists of Pittsburgh, 300 Penn Center
Analytical Chemistry News & Features, March 1, 1999
Blvd., Suite 332, Pittsburgh, PA 15235-5503 (800-825-3221; fax 412-825-3224). The deadline for applications is March 31; the recipient will be announced May 11.
Keene P. Dimick nominations Nominations are requested for the 2000 Keene P. Dimick Award for Chromatography, which recognizes accomplishments in the areas of gas and supercritical fluid chromatography. The prize is administered by the Society for Analytical Chemists of Pittsburgh and consists of a $5000 cash award presented at the Pittsburgh Conference at a symposium arranged by the recipient. Selection is based on overall accomplishments in the field of GC and/or SFC, including scientific publications, participation in conferences, contributions to science, and beneficial influence on other scientists. There are no restrictions of age, nationality, gender or professional affiliation. Letters of nomination including a complete resume for the nominee should be sent to Keene P Dimick Award Committee Society for Analytical Chemists of Pittsburgh 300 Penn Center Blvd Suite 332 Pittsburgh PA 15235-5503 The deadline for nominations is April 15
