Labyrinth BioPharma is an industry-recognized subject matter expert in lyophilization and formulation development. Our services are designed to bring that expertise to your project and team. Our offerings are flexible, which allows us to create a custom plan tailored to meet your specific needs. Formulations and lyophilization cycles are developed at the bench to your product specifications, then scaled-up to manufacturing levels.
Lyophilization Cycle Development
Lyophilization brings ease of transport, storage, and enhanced stability to poorly stable formulations. Characterizing the thermal properties of the formulated product through differential scanning calorimetry (DSC) and freeze-dry microscopy (FDM) allows an optimized cycle to be developed for the formulation. Thus, resulting in the product being dried in the shortest amount of time while still meeting all of the pre-determined release specifications.
Our expertise includes developing lyophilization cycles from the ground up, or optimizing problematic cycles that produce poor product performance, stability, and/or excessive cycle times.
Formulation Development
Developing a stable parenteral formulation begins with understanding the properties of the molecule of interest, including solubility, pH, stability profiles, degradation pathways, etc. By conducting a thorough pre-formulation development study we can greatly increase the odds for the successful development of a stable formulation, regardless of its final presentation. Labyrinth BioPharma has built a reputation of success in developing stable formulations, including liquid, emulsion, suspension, lyophilized, and large and small molecules.
Analytical Services
Labyrinth BioPharma offers analytical services for onsite testing, and to supplement the efforts of your scientists. We have the capability to test residual moisture by Karl Fischer, HPLC potency/purity, UV/Vis, FTIR, osmolality, pH, protein secondary structure elucidation, protein melting curves, Tg’ and Tg values, etc.