Product Characterisation and Specification
Once a formulation has been selected, MedPharm supports clients by defining the full product characterization with validated methods appropriate for the phase of development. The key focus is to create release and stability specifications that ensure the product’s quality without unnecessary complexities. MedPharm will ensure the specifications are relevant to monitoring the Critical Quality Attributes of the product.
Our process development experts are uniquely placed to predict and mitigate risks during the scale-up of the formulation. This is critical to achieving consistent product performance and quality at a stage of fundamental importance on the road towards commercialization.
Process development aims to establish optimal manufacturing conditions for a pharmaceutical product and ensure that it meets both quality and regulatory standards. MedPharm’s long experience in scale-up has shown that investigating early in understanding the process can prevent potentially expensive issues occurring during the supply of clinical batches and when starting commercial supply.
MedPharm uses the Quality by Design (QbD) principles outlined in ICH Q10 in the design and scale-up of any formulation. Combining an understanding of a product’s Quality Target Product Profile (QTPP) and subsequent Critical Quality Attributes (CQAs) with MedPharm’s years of experience, our scale-up team will recommend an efficient set of small scale experiments to test the sensitivity of the product to any Critical Process Parameters (e.g. mixing rate, cooling rate, etc) they have identified. The data maps out any critical limits of these parameters and ensures that subsequent batches can be made with consistent quality.
Process Development, QbD and Scale Up
Semi-Solid & Liquid Manufacturing
MedPharm manufactures batches for toxicology testing, clinical trials, registration, and commercial batches. Our teams have experience in compounding, filling, packaging, and labeling, ensuring products meet specifications for both clinical and commercial use around the globe. Our GMP accredited facilities are capable of manufacturing for all topical formulation types, including liquid and semi-solid manufacturing, in batch sizes up to 300 kg.
MedPharm supports clients with a seamless transition, from Formulation Development through to Product Manufacturing, ensuring an end-to-end service that compliments the client’s clinical research activity.
The MedPharm team can also support clients who are transferring the manufacture of their product to facilities all over the world.
Stability indicating methods are established early in the development process and can be appropriately validated for full-scale batch testing.
In order to simplify the compilation of a client’s regulatory submissions, all data is provided in IMPD/IND/CTD format. MedPharm provides stability testing in all ICH zones.