The MedPharm team can support clients all the way to full-scale manufacture.
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.
MedPharm’s analytical scientists endeavour to minimize the number of HPLC methods needed to measure active content, impurities, and excipients. They have the experience to efficiently validate in vitro release testing methods, which are increasingly being demanded by regulatory authorities to be part of product specifications.
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 also 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 many 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
Full Scale Manufacture
MedPharm manufacture batches for toxicology testing and clinical trials and can create registration batches for generic submissions. At this point the MedPharm team will be very familiar with the formulation and continuing to full-scale manufacture within the same team eliminates any potential for continuity errors that could impact a project’s commercial milestones.
Our teams have significant experience in filling, packaging, labelling and despatch of all formulation types, ensuring they are ready for use in clinical trials worldwide. Investigational product management services offered by MedPharm ensure an end-to-end service which complements the client’s clinical research activity.
Our GMP accredited facilities are capable of manufacturing all topical formulation types including liquids and semi-solids in batch sizes up to 100 kg.
The MedPharm team is experienced in supporting clients who are transferring the manufacture of their product to facilities all over the world. We are sensitive that this is a critical process and have protocols to ensure both the manufacturing process and any associated analytical methods are smoothly transferred.
MedPharm will always recommend that one of its senior scientists is present at the manufacture of the first batches at a new site.
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 can do stability testing in all ICH zones.