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Commercial databases accepted for GMP analyses

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(@event-participant)
Posts: 77
Member Admin
Topic starter
 

What kind of data base do you need, are these commercial available (by example via Waters, manufacturer of the MS) and are these accepted for GMP analyses


 
Posted : 14/04/2026 11:53 am
(@quality-experts)
Posts: 75
Trusted Member
 

The proteome protein databases can be downloaded from NCBI or Uniprot for all common expression systems. For GMP the database should be locked.

Ejvind Mørtz, PhD, Co-Founder & COO of Alphalyse in Denmark, discusses the regulatory expectations for HCP analysis, highlighting the importance of USP <1132.1> to improve MS-based data quality. Don’t miss his presentation and expert insights at the panel discussion.

Watch the On-Demand presentation here: https://bio-qc.com/regulatory-expectations-for-your-hcp-analysis-meet-usp-1132-1-to-enhance-the-quality-of-ms-based-data/


 
Posted : 17/04/2026 11:41 am
(@quality-experts)
Posts: 75
Trusted Member
 

Even though (CHO) protein databases are available, it is of added value to thoroughly analyse the pool of proteins expressed by the host cells used to build a proprietary database 

Don’t miss Eef Dirksen, Director of Analytical Development and Quality Control at Byondis (Netherlands), who discusses regulatory expectations for HCP analysis and highlights the importance of USP <1132.1> in improving MS-based data quality.

Watch the On-Demand presentation here: https://bio-qc.com/regulatory-expectations-for-your-hcp-analysis-meet-usp-1132-1-to-enhance-the-quality-of-ms-based-data/


 
Posted : 17/04/2026 11:41 am
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