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Smooth muscle is a central structure involved in the regulation of airway tone. In addition, it plays an important role in the development of some pathologies generated by alterations in contraction, such as hypercontractility and the airway hyperresponsiveness observed in asthma. The molecular processes associated with smooth muscle contraction are centered around myosin light chain (MLC) phosphorylation, which is controlled by a balance in the activity of myosin light-chain kinase (MLCK) and myosin light-chain phosphatase (MLCP). MLCK activation depends on increasing concentrations of intracellular Ca2+, while MLCP activation is independent of Ca2+. MLCP contains a phosphatase subunit (PP1c) that is regulated through myosin phosphatase target subunit 1 (MYPT1) and other subunits, such as glycogen-associated regulatory subunit and myosin-binding subunit 85 kDa. Interestingly, MLCP inhibition may contribute to exacerbation of smooth muscle contraction by increasing MLC phosphorylation to induce hypercontractility. Many pathways inhibiting MLCP activity in airway smooth muscle have been proposed and are focused on inhibition of PP1c, inhibitory phosphorylation of MYPT1 and dissociation of the PP1c-MYPT1 complex. [ABSTRACT FROM AUTHOR]

The HemoCen Aerobio is a general enrichment culture medium, destined to culture aerobics microorganisms in blood. Due to the importance of this product as a diagnosticator of microorganisms that affect human health, it is decided to implement the production of its three presentations in the Parenteral Products Plants at National Center for Bioproducts (BioCen). Therefore, this work is carried out with the objective of obtaining the production license from the Center for the State's Control of Medical Medicaments and Equipments (CECMED) for the HemoCen Aerobio Neonatal, the HemoCen Aerobio Pediátrico and the HemoCen Aerobio. Productive results of three lots of each one of the presentations are presented, which showed satisfactory and consistent results that fulfill the quality requirements according to the stablished specifications, that allowed to obtain the production license for the three presentations in the Parenteral Products Plants. [ABSTRACT FROM AUTHOR]

As part of the continuous improvement process, a new parenterals production plant (PPP3) was constructed at the National Center for Bioproducts. The validation of the aseptic filling process is a key element to carry out before manufacturing products. Therefore, the aim of this work was to obtain documented evidence that all the operations were carried out according the regulations of Good Manufacturing Practices for liquid and lyophilized sterile products during the aseptic filling at the Parenterals Product Plant 3. The study was designed for lyophilized products connected to the manifold of the peristaltic pump and to the four rotary piston pumps. Besides, during the filling operation four interventions were planned. The validation was carried out with three consecutive batches of media fill. In the first processed lot no vial was contaminated, but in the second and third lots there was one contaminated vial. For that reason, an investigation was performed in order to know the cause of the contamination. Finally, with this wok the validated condition was obtained, following the regulations of Good Manufacturing Practices for sterile liquids and lyophilizes products during the aseptic filling process at the Parenterals Products Plant 3. [ABSTRACT FROM AUTHOR]