Lyophilization
Lyophilization is a critical process for stabilizing pharmaceuticals, particularly for products that are sensitive to changes in temperature and chemical environment. It is especially effective in mitigating the risks of hydrolytic, oxidative, and aggregation reactions, which can compromise the potency and safety of liquid dosage formulations. For many proteins and antibodies freezing and/or thawing may cause some proteins to aggregate. Our lyophilization services overcome poor stability by rendering labile drugs and proteins more tolerant to long-term storage.
CuriRx develops lyophilized formulations via robust and cost-efficient processes. Our formulation team is experienced in screening effective combinations of solvents (both aqueous and non-aqueous), buffers, bulking agents, and lyo/cryo-protectants. We analyze and determine critical formulation parameters, including:
- Collapse temperature (Tc)
- Eutectic melting temperature (Teu)
- Glass transition temperature
- Crystallization phenomena
- Effects of annealing on ice crystal growth
- Solute structure
With this approach, our scientists ensure the development of efficient, safe, robust, and reproducible production cycles. This will in turn lead to an optimal final product that has low residual moisture/solvent, forms a solid and attractive cake, reconstitutes readily and completely, and resists physical and chemical degradation.
CuriRx’s lyophilization expertise allows for efficient technology transfer scalable process and plays a critical role in stabilizing pharmaceutical drug products, more reliable and efficient global distribution, storage, and clinical development. CuriRx focuses on critical formulation parameters and robust processes ensures the production of high-quality lyophilized products.
