Current and future trens in the quality control of pharmaceuticals and biopharmaticals : impacts on Cost of Goods Sold (COGS)

[Summary] 2. Roles of quality control in the pharmaceutical and biopharmaceutical industries. - 2.1. Pharmaceutical industry. - 2.2. Biopharmaceutical industry. - 2.3. Policy and regulatory. - 2.3.1. The US Food and Drug Administration (FDA). - 2.3.2. The European Medicine Agency (EMEA). - 2.3.3. The Japanese Ministry of Work, Labor and Welfare (MHLW). - 2.3.4. The Swiss Agency for Therapeutic Products (Swissmedic). - 2.3.5. The International Conference on Harmonization (ICH). - - 3. Types of testing. - 3.1. Microbiological purity tests. - 3.2. Physiochemical tests. - 3.3. Critical to quality steps. - 3.3.1. API starting materials and excipients. - 3.3.2. Intermediates. - 3.3.3. APIs (drug substances) and final drug product. - 3.3.4. Primary and secondary packaging materials fro drug products. - - 4. Manufacturing cost and quality control. - 4.1.1. Pharmaceutical manufacturing cost breakdown. - 4.1.2. Biopharmaceutical manufacturing cost breakdown. - 4.2. Batch failure / rejection / rework / recalls. - - 5. Future trends in the quality control of pharmaceuticals and biopharmaceuticals. - 5.1. Rapid and real time testing. - 5.1.1. Physio-chemicals testing. - 5.1.2. Rapid microbiology methods

Consultation pluridisciplinaire "Souffrance au travail": une expérience romande [Multidisciplinary consultation "Suffering at work": an experience in western Switzerland].

Les problèmes de santé mentale au travail constituent un défi à la fois clinique, professionnel, économique et de santé publique. Les coûts totaux qu'ils génèrent en Suisse équivalent à 3,2 % du produit intérieur brut (PIB) suisse et ils aboutissent très souvent à un licenciement. La grande majorité des personnes sont soignées par un médecin de premier recours. L'Institut de Santé au Travail propose une consultation spécialisée dans les questions de souffrance au travail, offrant aux soignants de première ligne un avis ou un soutien pluridisciplinaire, dans une perspective collaborative des soins. Son action, adaptée aux besoins de chaque situation, va d'un avis à une orientation vers des spécialistes pouvant étoffer durablement le réseau (suivi psychiatrique, programme de soutien à l'emploi, avis juridique ou social). Mental health problems at work constitute a challenge in the clinical feld, as well in the professional, the economic and the public health perspective. The total costs they generate in Switzerland are equivalent to 3.2% of the Swiss gross domestic product and they very often lead to dismissal. The vast majority of people are treated by their primary care physician. The Institute for Work and Health features a specialized consultation on the topic of suffering at work, offering the primary care physicians a pluridisciplinary advice or support, in a collaborative care prospect. Its action, adapted to each situation's needs, goes from an advice to a referral to specialists that can strengthen the network on a long-term basis (mental health follow-up, supported employment program, legal or social advice).

Immunologic work up of subjects who didn't respond appropriately to a rabies post exposure prophylaxis

Background New recommendations for rabies postexposure prophylaxis (rPEP) were published by the Centers for Disease Control and Prevention and the World Health Organization in 2010. In view of these new recommendations, the adequacy of rPEP among patients consulting the travel clinic of the University Hospital of Lausanne has been investigated and 6,8% of patients have been identified as non-responders with the new rPEP regimen. In this study we have selected the non-responders for a complete immunologic work up. Method Clinical and paraclinical immunologic investigations have been done to the non- responders patients. Those investigations have been conducted to look for an increased susceptibility to infections and an immunodeficiency. The investigations included a clinical evaluation, a full blood count, measurement of the immunoglobulin levels, a numeration of the subpopulations of the lymphocytes, a HIV test and an evaluation of the humoral response to tetanus, pneumococcal, and hepatitis B vaccinations. A lymphocyte proliferation assay with rabies antigen was performed to assess the cellular immune response. Results 9 subjects with rabies antibody titers ≤0,5 IU/ml after an rPEP with 4 doses were included in this study (=non-responders). 8/9 of these non-responders had an unremarkable medical history. 9/9 of them had normal paraclinical tests that did not suggest an immunodeficiency. The results of the lymphocyte proliferation assay with rabies antigen showed a significant correlation between the level of the humoral and cellular response. Conclusion These results suggest that a 4 dose intramuscular rPEP elicits in some patients a relatively poor humoral and cellular response, even in the absence of any immunosuppression. A serology on day 21 of the rPEP seems therefore useful to identify the patients who don't respond appropriately. Those non-responders should receive additional doses until they reach an antibody titer above 0.5 IU/ml.