Many factors such as host cell development, cell bank establishment, cell culture, protein production, purification, analysis, formulation, storage, and handling are critical for ensuring the purity, activity,

and safety of the finished product. Good Manufacturing Practice (GMP) for biodrugs has been developed in certain regions such as the EU, US, and Japan. Due to differences in manufacturing methods and systems, product-specific GMP guidelines are evolving. In general, there are variations in GMP guidelines between countries, which lead to difficulty SB273005 Cytoskeletal Signaling inhibitor for the manufacturers in conforming to different standards, thus entailing delays in the commercialization of biodrugs. There is a need to develop a unified regulatory guideline for biodrug manufacturing across various countries, which would be helpful in the marketing of products and trade. This review deals with the comparative framework and analysis of GMP regulation of biodrugs.”
“Background: Postoperative atrial fibrillation (POAF) is a frequent complication of coronary artery bypass

grafting (CABG) surgery. The objective of this study was to determine the impact of POAF on both short- and long-term mortality following isolated CABG. Hypothesis: POAF is associated with a poorer short and long-term mortality following CABG. Methods: We retrospectively analyzed the preoperative and operative data of 6728 consecutive patients undergoing a first isolated CABG. Results: The incidence of POAF was 27.8%. Operative mortality was higher in patients PXD101 ic50 selleck chemical with POAF compared to those without

POAF (2.3% vs 0.9%, P < 0.001). On multivariate analysis, POAF remained an independent predictor of operative mortality (odds ratio [OR]: 1.78, P = 0.01). Patients with POAF also had reduced long-term survival (6-year survival: 85.3% vs 89.2%, P < 0.001). After adjusting for other predictors of mortality, POAF was significantly associated with increased long-term mortality (hazard ratio [HR]: 1.35, P = 0.04). Of note, after adjustment for potential confounders, statin treatment had a highly protective effect in POAF patients for both operative mortality (OR: 0.38, P = 0.003) and long-term mortality (HR: 0.62, P = 0.03), whereas it had no significant effect in patients without POAF. Conclusions: POAF is an independent predictor of both short- and long-term mortality following CABG. Moreover, statin therapy was independently associated with better survival in patients with POAF. Dr. Pibarot holds the Canada Research Chair in Valvular Heart Diseases, Canadian Institutes of Health Research. Dr. Mathieu is a research scholar from the Fonds de Recherches en Sante du Quebec, Montreal, Canada. Dr. Despres has served as a speaker for Abbott Laboratories, AstraZeneca, Solvay Pharma, GlaxoSmithKline, and Pfizer Canada Inc.