Sentence examples for aseptic manufacturing from inspiring English sources

The aseptic processing of operators must also be confirmed by performing media fills (the performance of an aseptic manufacturing procedure using a sterile microbiological growth medium in place of the drug solution).

While aseptic manufacturing is always an option, this can be quite complicated, in particular for a multiple step process that involves handling and transfer of materials in a "sterile" environment.

The major drawback for the progression of polymeric particles towards clinics is the difficulty to scale up and to develop cost-effective individual manufacturing processes under aseptic good manufacturing practices (GMPs).

Results demonstrated that both the procedure and personnel involved were able to maintain and guarantee aseptic conditions during all phases of manufacturing process (data not shown).

Now that researchers at Sanaria have developed the methods for manufacturing, characterizing, and shipping aseptic, purified, cryopreserved PfSPZ that meet all regulatory standards, CHMI will be available to investigators at any clinical research center in the world, including malaria-endemic countries.

Throughout the manufacturing process and prior to aseptic lyophilisation (19), the product is filtered several times using 0.22-μm sterilising-grade or sterile filters, in order to comply with the stringent quality requirements necessary for parenteral pharmaceutical products.

If insufficient peripheral blood mononuclear cells are obtained then a second leukapheresis will then be performed on day 6. Isolation of CD133+ HSC from the harvested peripheral blood mononuclear cells is performed under aseptic conditions within clean room facilities in accordance with good manufacturing practice regulations (Medicines and Healthcare products Regulatory Agency, MHRA/HTA, UK).

Can your R&D production method be scaled up? Cell flasks vs. cell factories Availability of GMP grade raw materials Automated aseptic processing e.g. sepax, COBE, cliniMACS, WAVE, prodigy What is the national/international manufacturing strategy i.e. hubs vs. single manufacturing centre?

The controlled and aseptic nature of these in vitro systems makes them readily compliant with good manufacturing practice and suitable for the production of therapeutic proteins [ 6].

Producing near net shape components with graded compositions using LENS™ could potentially be a viable route for manufacturing unitized structures for metal-on-metal prosthetic devices to minimize the wear-induced osteolysis and aseptic loosening that are significant problems in current implant design.

Due to the inherent microbial vulnerability of aseptic-UHT product formulations, the safety and stability-related Performance Objectives (POs) required at the end of the manufacturing process are the most demanding found in the food industry.