Newsletter | April 9, 2020

04.09.20 -- Improve Process Development Efficiency And Outcomes

 

Process development (PD) entails a myriad of experimental runs and data analysis. With the ever-increasing push for shorter timelines and more cost-efficient processes, solutions for robust processes and increased PD efficiency are treasured.

Raw material variability: the need for deeper chromatography process understanding
 

As molecular diversity increases, it is critical to understand the sources of process variability in order to mitigate risks. Read about one source of variation, chromatography resin raw materials.

Best practices for a successful bioprocess technology transfer
 

If you’re bringing a new facility online, or working with a CDMO, a well-executed tech transfer plan is critical to ensure optimal process reproducibility. Here are five tips to maximize tech transfer efficiency and success.

Understanding and controlling raw material variation in cell culture media
 

Manage variability through advanced analytical methods and risk-based assessment. Read about ways to look at raw materials assessment and risk mitigation.

Mechanistic modeling of chromatography to speed up process development and provide improved processes
 

What is mechanistic modeling in chromatography? Check the opportunities and challenges of an approach that can help make process development become faster, more scientific, and more reliable.

Optimizing cell culture media to increase cell culture titer with maintained protein quality
 

When evaluating media with the goal of increasing titers, it is important to ensure that protein quality is not negatively impacted. So how can this process improvement be performed reliably? It makes sense to use a design of experiments (DoE) and empirical approach. Here is an example of how to do that.