The traditional business model for in-house pharma manufacturing is nearly a thing of the past. More companies are turning to outsourcing to achieve flexibility and efficiency in a highly competitive market.
In a scenario where manufacturing processes move to a continuous flow, analyzers are producing data simultaneously, necessitating real-time processing and cloud-based tools for data management.
Glass breakage is commonly acknowledged as a major nuisance in parenteral manufacturing. It causes a plethora of problems, such as disruption of production, particle contamination and loss of sterility.
As pharma companies evaluate the delivery systems for their drug product, there are several reasons why they may select a cartridge-based system compared to a pre-filled syringe or vial.
A problem with traditional mAb manufacturing is that there are so many potential entry points for microbial contamination. There are, however, ways to shut the door on contamination.
Understanding the impact of powder behavior during pre-formulation will ensure clinically effective products and provide critical process knowledge to design an efficient and reproducible manufacturing procedure.
The plug-and-play nature of single-use enables you to incorporate new technologies and innovations into the process workflow as they become available. But you need to consider your long-term needs.
Engaging clinical supply management and forecasting adds value by evaluating different response strategies and contingency plans and can identify supply solutions that minimize or even potentially avoid supply chain disruptions.
Most issues in pediatric drug development arise from the fact that drugs are traditionally developed for adults and not children. Dr. Meyers shares the hurdles and improvements in pediatric drug development.
An outline of the cell development and process scale-up for an antibody program in which the antibody requires additional processing by a site-specific enzyme for correct functionality.
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