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With drug development trends shifting towards personalized medicines, new technologies are needed for the manufacture of these highly sensitive drug products.
With drug development trends shifting towards personalized medicines, new technologies are needed for the manufacture of these highly sensitive drug products. Lyophilization is widely used to preserve biopharmaceuticals. The process involves three steps: freezing, primary drying, and secondary drying. The challenge, however, is in process optimization and reducing cycle time, said Stephan Reuter, managing director of Optima, at the Optima O! talks session. Sharing insights on lyophilization process technology, Reuter stressed the importance of ensuring that each vial in the freeze dryer is subject to the same condition, which means the shelves must have homogenous temperature distribution. Reuter also explained that the freezing step determines the texture of the ice crystals. This is where controlled nucleation can help optimize freezing of the product. "You get better quality product with controlled nucleation and shorter drying times," said Reuter. Controlled nucleation, however, is not yet widely implemented in the industry, according to Reuter, partly because the technology is still considered to be in its infancy.
In aseptic processing, isolator technology is increasingly being chosen over cleanrooms, mostly driven by the need to minimize downtime. One of the advantages with isolator technology is the short change over times. "Isolators offer high flexibility and have better sterility levels than RABS," said Marc Bechler, sales manager, Metall+Plastic, Optima, when speaking on trends in barrier Systems during the Optima O! talks. Bechler provided an overview of how a catalytic converter, which can be easily retrofitted to an isolator, enables the reduction of cycle time by 50%. According to him, the cycle beginning from leak detection and dehumidification to decontamination with hydrogen peroxide and aeration takes approximately two hours.
At ACHEMA, it is evident that the process industry is striving to understand every aspect of a particular process so that it can be further optimized. It’s all about reducing run times and cutting down on costs without affecting product quality – and that’s what you call process optimization.