Course Description:
Raw materials, in particular cell culture media, represent a significant source of variability to biopharmaceutical manufacturing processes that can detrimentally affect productivity and product quality. Historically, processes were designed based on the productivity enhancing properties of inherently complex raw materials such as hydrolysates or sera. The indus¬try has now shifted to chemically defined media which have demonstrated direct improvements in productivity. Nevertheless, cell culture media remain a source of variability, whether from complex or chemically defined media. Screening of complex raw material lots becomes an important exercise. There has been a strong shift towards this screening approach where spectroscopic methods can enable the detection of lot to lot variability in complex raw materials and ultimately the correlation to process performance. Establishing control of raw materials based on an understanding of their impact on productivity and product quality has been identified as a part of the control strategy. Here we provide an overview of the strategy, analytical approaches used for characterization, and identification of any potential root causes of variability.
The live version of this recording took place on April 16, 2021 and features
a presentation by Sandeep Salunke
Who should participate:
- Analytical chemists
- QA/QC analysts
- R&D scientists, managers
- Team members in CMC development projects
- Manufacturing scientists, managers
- Regulatory affairs specialists
- Contract research organizations
- Contract manufacturing organizations
Access Duration:Access to this course expires 60 days from the date of registration or until you mark the course ‘Complete’ – whichever occurs first.