ProJect Pharmaceutics has specialized in this emerging field with a key expertise in development of stable, effective and syringe-able formulations together with their eligible processes.
Transforming therapeutic proteins into high-concentrated, stable and easy to use medications for subcutaneous injection (s.c. self-administration) can add up to a major challenge along their clinical development. A syringe formulation’s fundamental qualification, such as appropriate physico-chemical stability, container material compatibility and viscosity must be taken into account to support an acceptable in-syringe shelf-life, as well as convenience in regard to syringe-ability. In order to address these various requirements and develop a pioneering new drug in a prefilled syringe drug presentation, a great extent of knowledge, expertise and sophisticated analytics is needed that are sparingly found in this developing market to date.
ProJect Pharmaceutics has specialized in this emerging field of s.c. formulation with a key expertise in development of stable, effective and syringe-able formulations together with their eligible processes. Be it conformation of de-novo drug products towards a pre-filled syringe application or transfer of existing drug products into the like, ProJect Pharmaceutics features all the required key qualifications as well as supportive methods on-site:
- UF/DF process development
- Particles size distribution and aggregate analysis
- Analysis of sub-visible particles
- Viscosity determination and syringeability testing in prefilled syringes or cartridges
By applying an elaborate science-based approach to meet well-established critical quality attributes such as e.g. maximum effectiveness, high concentration for low injection volume, low aggregate content and a low viscosity formulation, ProJect Pharmaceutics offers profound guidance and support on the development of pioneering parenteral biologics, either as highly concentrated drugs (HCLFs) or easy-to-reconstitute high concentration lyophilizates.
Minimizing viscosity and aggregation by actively maximizing repulsive protein-protein interaction in solution is one of the key techniques applied. Additionally, shifting thermodynamic protein stability in solution to its maximum represents another key requisite to promote long-term stability of liquid formulations in pre-filled syringes.
Designed high concentrated formulations’ syringe-ability is measured directly in-system mimicking the typical administration procedure of the patient (measurement of break-loose and gliding forces).
In case stability in aqueous solution is found to be limited by the biologic ́s inherent sensitivity, freeze-drying clears the way forward. Innovative design of high concentration lyophilization formulations and freeze-drying processes developed by ProJect Pharmaceutics reliably overcome the hurdles of reconstituting high-concentrated protein lyophilizates.
Supply of aseptic pre-clinical study material in pre-filled syringes at pilot scale complete ProJect Pharmaceutics’ excellence as your pharmaceutical service provider in this exigent field of highly concentrated protein formulation development.