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Published on: January 12, 2010
Establishment of replacement batches for prekallikrein activator in albumin biological reference preparation
Insights
New biological reference preparations for prekallikrein activator were established by the European Directorate for the Quality of Medicines and HealthCare (EDQM). These replacements ensure continued availability of critical standards for quality control in pharmaceutical development.
Area of Science:
- Pharmacology and Pharmaceutical Sciences
- Biotechnology
- Quality Control and Standardization
Background:
- The European Directorate for the Quality of Medicines and HealthCare (EDQM) initiated a study to address dwindling stocks of the Prekallikrein activator in albumin Biological Reference Preparation (BRP) batch 1.
- This initiative was part of the Biological Standardisation Programme (BSP) to ensure the continuity of essential biological standards.
Purpose of the Study:
- To establish and validate replacement batches (batch 2 and batch 3) for the Prekallikrein activator in albumin BRP.
- To ensure the potency and suitability of the new batches as international standards for prekallikrein activator determination.
Main Methods:
- A collaborative study involving sixteen laboratories was conducted.
- Candidate batches were manufactured using identical starting materials and lyophilisation conditions as the existing BRP.
- Assays were performed using routine methods compliant with the European Pharmacopoeia (Ph. Eur.) general method 2.6.15.
Main Results:
- Candidate batches were assayed against the 2nd World Health Organization International Standard for Prekallikrein activator, human and the existing BRP batch 1.
- Central statistical analysis confirmed the assigned potency of the existing BRP batch 1 (29 IU/vial).
- The two candidate replacement batches were assigned a potency of 30 IU/vial.
Conclusions:
- The two candidate batches successfully met the requirements to serve as replacements for the Prekallikrein activator in albumin BRP batch 1.
- The European Pharmacopoeia Commission adopted these candidates as Ph. Eur. Prekallikrein activator in albumin Biological Reference Preparation batch 2 and batch 3 in March 2008.
Abstract:
A collaborative study was run by the European Directorate for the Quality of Medicines and HealthCare (EDQM) under the aegis of the Biological Standardisation Programme (BSP) to establish replacement batches of the current Prekallikrein activator in albumin Biological Reference Preparation (BRP) batch 1, the stocks of which were dwindling. Candidate BRP replacement batch 2 and batch 3 were assayed against the 2nd World Health Organization International Standard for Prekallikrein activator, human (2nd IS) and the Prekallikrein activator in albumin BRP batch 1. The candidate batches were manufactured from the same starting material as the current Biological Reference Preparation and the 2nd IS. They consisted of a 20 % solution of albumin lyophilised under the same conditions as the Prekallikrein activator in albumin BRP batch 1. Sixteen laboratories participated in the collaborative study and were requested to assay the candidates by their routine method, complying with the European Pharmacopoeia (Ph. Eur.) general method 2.6.15 for the determination of prekallikrein activator content. A central statistical analysis was performed at the EDQM using in-house calculations of prekallikrein activator contents provided by the participating laboratories. On the basis of the results of this study, which confirmed the assigned potency of 29 IU/vial of Prekallikrein activator in albumin BRP batch 1, the 2 candidate materials were assigned a potency of 30 IU/vial. The 2 candidates were adopted by the Ph. Eur. Commission in March 2008 as Ph. Eur. Prekallikrein activator in albumin Biological Reference Preparation batch 2 and batch 3.
