Case Study

Solving Process Challenges Requires Flexibility To Explore Alternative Analytical Methods

By Shaonly Saha

DIA Combination Products Conference

Successful and rapid analytical method development plays a key role in ensuring the development of robust processes that provide high-quality products.  When standard or predefined methods fail because of buffer components or proteins do not behave as expected, solutions can be found when the team has the flexibility and freedom to explore the use of alternative methods.

Analytical tools are the key to understanding and optimizing any process, and having the experience and means to explore alternative methods allows the analytical scientist to rapidly meet the demands of any project. Where appropriate, established methods based on existing standard operating procedures (SOPs) and protocols are relied upon. When those established methods fail, custom solutions are developed to meet the needs of the product and project.

The freedom to use alternative methods to solve problems is the key to developing novel protein molecules.  These two case studies demonstrate the value brought to the process when scientists with extensive training are given the freedom to apply their knowledge and identify new approaches to the challenges we face.  Each challenge builds on the existing foundation and improves the traditional methods to increase efficiency, productivity, and quality. 

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