Lyophilization
Lyophilization is crucial for stabilizing your therapeutic agents into ready-to-use solution dosage forms. These complex molecules undergo hydrolytic, oxidative, and aggregation reactions, compromising both potency and safety. In solution, they are susceptible to even modest changes in temperature and chemical environment. For many proteins and antibody 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.
Our scientists have the specialized expertise necessary to overcome these barriers, yielding a dry, stable product that will:
- Facilitate global transport and storage
- Withstand adverse environmental challenge
- Enable drug sponsors to expeditiously move through clinical trials
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
- the 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.
