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Quality control in the development of coagulation factor concentrates.
Developments in Biological Standardization
|January 1, 1987
Summary
Ensuring pharmaceutical quality requires careful assessment of process changes, especially for coagulation factor concentrates. Introducing viral inactivation steps like heat treatment presents significant challenges in predicting product safety and efficacy.
Area of Science:
- Pharmaceutical Manufacturing
- Biologics Quality Control
- Process Development
Background:
- Process change limitation is key to pharmaceutical quality assurance.
- Coagulation factor concentrates rely on presumptive testing for quality control.
- Developing new preparations necessitates evaluating process alteration impacts.
Purpose of the Study:
- To assess the impact of process changes on coagulation factor concentrate quality.
- To evaluate the challenges of introducing viral inactivation steps.
- To illustrate problems with heat treatment of factor VIII and prothrombin complex concentrates.
Main Methods:
- Assessing the effect of process alterations on finished product characteristics.
- Evaluating the predictability of finished product tests.
- Analyzing challenges associated with terminal dry heat-treatment (72h at 80°C).
Main Results:
- Process alterations in coagulation factor concentrate manufacturing require thorough assessment.
- The complexity of process changes influences confidence in product safety and efficacy.
- Terminal dry heat-treatment posed challenges for factor VIII and prothrombin complex concentrates.
Conclusions:
- Rigorous evaluation is essential when modifying pharmaceutical manufacturing processes.
- Viral inactivation steps introduce complexity in ensuring product quality and predictability.
- Case studies highlight the difficulties in validating heat treatment for coagulation factor concentrates.