Development of an Ultrafiltration/Diafiltration process for high Concentration/Viscosity applications. (La Vague 51)
The successful launch of several monoclonal antibodies (Mab) in recent years has revealed not only their potential but also the challenges of production for injection in therapeutic doses. In this context, the formulation of a highly concentrated product is key for the production of volumes that are injectable subcutaneously, typically around 1mL.
A platform process is producing a suitable process for the manufacture of a group of related products in a defined generation system. At Lonza one of our technology platform offerings is a process for the manufacture of therapeutic proteins in Chinese hamster ovary (CHO) cells.
The environmental control of classified areas within cleanrooms is provided by systems controlling humidity, air temperature, air change and filtration, by the maintenance of pressure differentials and by “good practices” such as room cleaning and disinfection, access restriction and the implementation of appropriate flows. Failure of one of these systems or practices represents a “major event” which can potentially have an impact on Controlled Atmosphere Area (CAA) status.
Influence of the hardness of bacteriological cultivation media on environmental monitoring with impaction like air samplers. (La Vague 51)
Microbiological controls of the environment in clean rooms are now included in MOST recommendations and Regulatory documents. For example, in the guide "Good Manufacturing Practices (GMP)" (1) That it is recommended limits and values of microorganisms in the air and on the surfaces are Applied in the different clean room classes (AD). This guide is the French translation of the guide for European Good Manufacturing Practice (2). In the hospital environment, the French standard NF390351 imposed microbiological values of the air and surfaces based on defined risk environments.
In the current context of media attacks on antimicrobial preservatives, the cosmetic industry must innovate to continue to develop products devoid of all microbiological risks, without new use restrictions for consumers.