I’d like to describe major elements in the Raw Material Characterization program as it is currently conceptualized. I do expect it to evolve and be modified as we learn more during development and implementation. Right now we have seven projects identified that form our backbone.
Project 1: Development of a Searchable Database
- Create a common database with the ability to search for correlations between characteristics of raw materials and biological or physical effects. Create additional capability to determine similarity of formulations and developing “media family trees”.
- Search capabilities to link assay data with formulations or components
- Ultimately develop a customer web accessible database with links to raw materials used in media
Project 2: Developing a Prioritized List of Raw Materials
- Develop criteria to create prioritized list of raw
- Rank raw materials and develop a “Top 100” list for initial characterization work
Project 3: Development and Verification of Analytical Assays
- Develop sensitive analytical assays to characterize raw materials, contaminants and changes in recombinant protein product quality
- Detect chemical differences in raw materials that may affect performance
Project 4: Development and Verification of Biological Assays
- Develop sensitive and reproducible biological assays to detect changes in cell culture growth, productivity and product quality
- Detect biological differences in cell culture growth, productivity and product quality
- Correlate observed differences with biological performance
Project 5: Drive Specifications
- Reduce variability in media performance by controlling specifications.
- Recommend new specifications to minimize risk of contaminants identified via analytical and biological testing
Project 6: Physical Effects of Raw Materials in Complex Media
- Create database predicting chemical reactions and solubility limits for mixtures of raw materials
- Use information to improve stability of formulations
- With improved predictability, reduce cycle times for concentrate feasibility assessment
Project 7: Biological Effects of Raw Materials in Complex Media
- Improve methods for media development by better understanding the biological effects of raw materials in complex media
- Create database predicting the effects of raw material changes on media performance and metabolic pathways
- Provide an enhanced understanding of risk associated with medium formulations
Our goal is to be more empirically driven. We want to thoroughly understand our products and processes. We’d plan to use that information to create more robust products, increase the speed of our product development, and to provide greater product related support to our customers. Ultimately, we will increase our ability to manage product (raw material) related risk and provide greater transparency to our customers.
My next post will address aspects of biological testing.
Posted by Bruce Lehr Jan 10, 2010