Understand the full potential of QbD in upstream processing.
How a proactive approach involving predictive — rather than preventive — tools to identify deficiencies before they compound and become actual problems can result in a healthy bioprocessing facility.
Changing and creating documentation involves many disciplines and long lead times. This case study explains how to improve Global Documentation Change Control Processes quickly and easily.
The reality is that several manufacturability problems could be brewing that will rain down during Phase III and cause costly delays, no matter how skilled the product and process may be.
Current market conditions such as regulations and mergers or acquisitions make improving compliance and manufacturing efficiency while driving to grow revenue and margins difficult.
While there are a certain amount of commonalities in regulations in each country, there are differences which necessitate care from global manufacturers when distributing products.
Real-time release testing can be defined as a set of in-process controls that may provide greater assurance of product quality than end-product testing.