Stability over 36 months of a new liquid 10% polyclonal immunoglobulin product (IgPro10, Privigen) stabilized with L-proline.

BACKGROUND AND OBJECTIVES: IgPro10 (Privigen) is a new liquid intravenous immunoglobulin (IVIG) product that is formulated with 250 mM L-proline at pH 4.8. A 3-year study was performed to assess its stability. MATERIALS AND METHODS: Physicochemical, biological and immunological parameters of Privigen were assessed during storage under controlled conditions over up to 36 months at 25 degrees C. RESULTS: Privigen was shown to be stable after storage for 3 years at room temperature (25 degrees C). Of all parameters tested, only a few showed changes during storage. The appearance of the solution complied with the specifications given by the European Pharmacopeia over the full study period, with a single exception. The IgG fraction in Privigen displayed high purity (> or = 98%), which did not change during storage over 36 months. No relevant amounts of aggregated IgG molecules were formed in Privigen samples and the ratio between monomers and dimers shifted slightly towards the equilibrium over time. Testing of reference antibody contents and the Fc function demonstrated that the biological activity and effector functions of Privigen were preserved over the full study period of 36 months. CONCLUSION: Thirty-six months room temperature stability of Privigen was achieved at pH 4.8 with an innovative formulation containing the physiological stabilizer L-proline.

Smoke-free cafe in an unregulated European city: highly welcomed and economically successful.

OBJECTIVE: In a unique setting with two identical cafes, which only differed in their smoking ordinances, this study assessed the influence of smoking policies on the choice of the cafe, investigated regulatory preferences among customers, and evaluated the claim that smoking cafes have better sales performance in a city without smoking bans. METHODS: In a parallel assessment, customers of both cafes answered a questionnaire. Sales were compared and air pollutants were measured to confirm air quality differences. RESULTS: The two customer groups (n = 177) differed only with regard to smoking status (p < 0.01). The smoking regulation was the most often cited selection criterion (83%). In the non-smoking café, 89% indicated that they were usually annoyed by smoke in coffee houses, and 62% would avoid or leave cafes for this reason. Two thirds stated that all cafe/restaurants should offer the opportunity of a smoke-free environment. However, almost half stated that mandatory regulations are not needed and that customers should make individual arrangements based on tolerance and courtesy. Those who were informed about the health effects of secondhand smoke were more likely to call for clear policies. Whereas sales showed no differences, tips were 22% (p < 0.001) higher in the non-smoking cafe. CONCLUSION: In a generation raised in smoking friendly environments, customers paradoxically ask for a landmark shift towards smoke-free opportunities, while substantially adhering to the tobacco industry paradigm of promoting "tolerance" rather than smoke-free policies. Given the clear preference of a large number of customers, hospitality businesses could, however, greatly profit from offering smoke-free environments even in the absence of regulatory policies.