- Process Development, QbD and Scale Up
MedPharm understands that entering the clinical development stage requires a significant financial commitment by the Sponsor. Providing a suitable quantity of investigational products which are well characterised and which will retain their quality throughout the clinical trial is of paramount importance.
When larger quantities of a product are required for Phase II and III clinical trials the investment and hence the client risk increases substantially.
MedPharm has process development experts with the knowledge and skills to de-risk the scale up of the formulation. This is critical to achieving consistent product performance and quality and a stage of fundamental importance on the road towards commercialisation.
MedPharm has supported over 50 topical and transdermal products currently on the US and UK markets.
MedPharm is uniquely placed to predict from its experience the likely critical process parameters and can design experiments to confirm both critical material attributes and the optimal manufacturing process.
MedPharm will consult closely with client and any contract manufacturing organisation selected for the commercial supply to avoid issues at the later stages of the commercialisation process.
- Clinical Manufacture
MedPharm can manufacture batches for toxicology testing and clinical trials and hence can navigate our client’s product development from initial development right through to regulatory approval after Phase III clinical trials.
MedPharm has GMP accredited facilities for manufacturing all topical formulation types including liquids and semi-solids in batch sizes up to 200L/100kg.
MedPharm has been supplying toxicological and clinical batches to the US, Europe and other global markets for over ten years.
MedPharm has clinical manufacturing facilities at the same site as its formulation development group which greatly simplifies and facilitates project management at this critical stage of development.
MedPharm has significant experience in filling, packaging, labelling and despatch of all formulation types such that 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.
MedPharm QP’s and Quality professionals ensure that all processes and relevant documentation are checked and meet GMP standards.
- Product Characterisation and Specification
MedPharm understands the importance of product characterisation since many parameters can have a direct impact on product performance or stability.
MedPharm’s (QC department) has great experience in finished product testing across a wide range of formulation types whether for batch release or supporting ICH stability studies.
MedPharm scientists appreciate the need for validation of analytical methods and the compilation of a suitable product specification commensurate with the stage of development of the product. All testing is carried out against a phase appropriate specification and our Quality professionals ensure all testing and documentation meets regulatory requirements for GMP and Data Integrity.
- Technical Transfer
MedPharm has many years’ experience working with a large number of full scale contract manufacture organisations selected by clients for commercial supply.
MedPharm provides commercial manufacturing facilities which have been selected by the customer with all the key information needed for a smooth transfer of both manufacturing process and the analytical methods. All testing is carried out against a phase appropriate specification and our Quality professionals ensure all testing and documentation meets regulatory requirements for GMP and Data Integrity.
MedPharm frequently supports transfer by sending members of its technical team to the client’s chosen commercial manufacturing facility to assist in early batch manufacture and facilitate successful transfer.
MedPharm have navigated clients through the complexities of regulatory submissions by providing strategic consultancy and if required attending scientific advice meetings.
- ICH Stability
MedPharm track the stability of formulations from early development proof of concept studies through to clinical manufacturing batches.
Stability indicating methods are established early in the development process and can be appropriately validated for clinical batch testing.
MedPharm can test the stability of clinical batches under all relevant ICH storage conditions.
MedPharm will provide all data in IMPD/IND/CTD format, thereby simplifying the compilation of client’s regulatory submissions.