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Collaborative study for the establishment of replacement batches for somatropin CRS batch 1
A Daas1, B Rafferty, M-E Behr-Gross
1European Directorate for the Quality of Medicines, Council of Europe, BP 907, F-67029 Strasbourg Cedex 1, France.
Pharmeuropa Bio
|February 3, 2007
Summary
The European Pharmacopoeia established new somatropin reference standards through a collaborative study. These new somatropin Chemical Reference Substance (CRS) batches ensure accurate quality control for somatropin drug products.
Area of Science:
- Pharmacopoeia Standards
- Biopharmaceutical Analysis
- Chemical Reference Substances
Background:
- The European Pharmacopoeia (Ph. Eur.) requires robust reference standards for quality control of pharmaceutical products.
- Existing somatropin Chemical Reference Substance (CRS) batches needed replacement to maintain analytical accuracy.
Purpose of the Study:
- To establish replacement batches for the Ph. Eur. Somatropin CRS.
- To demonstrate the suitability of candidate reference preparations for key somatropin quality tests.
Main Methods:
- A collaborative study involving 22 laboratories from 16 countries.
- Testing candidate reference preparations using peptide mapping, capillary electrophoresis (CE), and assays.
- Evaluation against current Ph. Eur. monographs for somatropin bulk solution, somatropin, and somatropin for injection.
Main Results:
- One candidate was adopted as somatropin CRS batch 2 in March 2006.
- A second candidate was adopted as somatropin/desamidosomatropin resolution mixture CRS batch 1 in June 2006.
- The somatropin CRS batch 2 was assigned a content of 1.69 mg somatropin monomer per vial.
Conclusions:
- The collaborative study successfully validated new reference standards for somatropin.
- The new CRS batches will support accurate identification, impurity profiling, and assay of somatropin.
- The somatropin/desamidosomatropin resolution mixture CRS is specifically designated for related protein testing.
