Consistency and Reliability Are Key to Trusted Quality

[AnalyteGuru_KB4]

Eating food is necessary to keep ourselves healthy and alive. Making food at home offers the choice to choose the ingredients and components to achieve a result we want; we can follow recipes or we can make our own recipes, but the result ultimately depends on what we put into it. Eating out is often a good alternative as it takes the burden off our shoulders. Sometimes we fancy something special from an independent restaurant and sometimes we just want something we tried and liked from a chain. There is one pasta I really like from an Italian restaurant, and I know that wherever I go in the country and visit this restaurant I get the same taste and I trust that I will eat something I really like. I can rely on this every time.

With regards to the trusted quality of the biopharmaceuticals, analytical methods and workflows have to be developed and components locked down to generate reliable results which will provide a tool for guaranteeing the drug is doing what it needs to - exactly that and nothing less - and it is of acceptable quality. To ensure this, analytical scientist must characterize the biological molecules to look at all possible quality attributes which may have an effect on the behavior of the molecule and to find critical ones which need to be controlled in order to ensure that required quality. They look at the candidates from all the way through discovery and development to quality control and lot release. The Thermo Scientific™ HR Multi-Attribute Method (MAM) is a powerful high resolution accurate mass (... that has been designed to simplify and standardize biopharmaceutical characterization and quality control. This analytical workflow has been developed and verified by a single vendor with specific products provided by Thermo Fisher Scientific.  The benefits of a standardized workflow solution are that the generated results are reliable for analytical processes on multiple instruments across different development sites, from research and development to manufacturing and QC.

Read this application note where examples of robustness and reliability are presented across instruments and technical replicates to learn more.

What further installs trust in the results is that a system suitability test standard is part of the workflow package and you can test your systems are generating the reliable and consistent results you need even if they are in different labs of your company. In a global pharmaceutical environment this kind of analytical procedure standardization offers peace of mind when preparing regulatory filings. Moreover, you can take advantage of full workflow support, globally, from a dedicated team of Thermo Fisher Scientific MAM experts.

Get the same results every time at any sites with the same system setup to rely on the data independent of where the biopharmaceutical is produced globally.