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Published on: August 3, 2013
Freeze drying formulation using microscale and design of experiment approaches: a case study using granulocyte
Yitzchak Grant1, Paul Matejtschuk, Christopher Bird
1Department of Biochemical Engineering, The Advanced Centre for Biochemical Engineering, University College London, Torrington Place, London, WC1E 7JE, UK. yitzchak.grant@kraftfoods.com
Biotechnology Letters
|December 22, 2011
Summary
Lyophilization in microplates rapidly optimizes therapeutic protein formulations, including those needing cell-based assays. This high-throughput method identifies key excipients like human serum albumin for enhanced granulocyte colony-stimulating factor stability.
Area of Science:
- Biotechnology
- Pharmaceutical Sciences
- Protein Formulation
Background:
- Lyophilization is crucial for protein drug stability.
- Assessing protein formulations typically requires significant material and time.
- Developing stable therapeutic protein formulations, especially for cell-based assays, is challenging.
Purpose of the Study:
- To demonstrate the utility of microplate lyophilization for optimizing therapeutic protein formulations.
- To identify optimal excipients for stabilizing granulocyte colony-stimulating factor (G-CSF) during freeze-drying.
- To validate the relevance of microplate data to pilot-scale lyophilization and assess long-term stability.
Main Methods:
- Utilized factorial design of experiments combined with microplate lyophilization.
- Conducted an initial screening of excipients followed by a central composite face optimization experiment.
- Validated the optimal formulation in stoppered vials and assessed solid-state shelf-life using accelerated stability studies.
Main Results:
- Successfully identified key excipients, including human serum albumin and Tween 20, significantly impacting G-CSF stability.
- Demonstrated that microplate lyophilization data correlates with pilot-scale freeze-drying results.
- Confirmed the stability of the optimized formulation through accelerated stability testing.
Conclusions:
- Microplate lyophilization offers a high-throughput, cost-effective approach for early-stage protein formulation development.
- This method is applicable to therapeutic proteins requiring complex biological assays.
- The approach accelerates the identification of stable formulations, reducing development time and material costs.
