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MDC Connects: A Guide to Complex Medicines, featuring SEDA

Recently, SEDA scientists have been featured in MDC Connects: A Guide to Complex Medicines which reflects a series of webinars that was organised by Medicines Discovery Catapult (MDC) back in 2021. As mentioned in the guide, the aim of the webinars was to educate, inform and advise the scientific community on the opportunities and challenges presented by the discovery and development of Complex Medicines.

The importance of developing both suitable characterisation techniques and biological assays to enable better understanding of the structure-function relationship of the nanomedicines as well as their safety is well highlighted in the guide. For instance, CryoTEM has been used to study membrane-bound structures, and specialist biological experiments based on advanced microscopy were developed to explore further the cellular trafficking of the nanomedicines such as uptake, endosomal escape (known as being the critical/ limiting step in intracellular delivery) and biological response.

Additionally, the importance of good formulation was demonstrated by Dr Claire Patterson, Senior Principal Scientist at SEDA during Webinar 6: Ready for the Clinic / Scaling-up for Success. The design of appropriate carriers with the identification of their critical quality attributes (CQAs) desirable for the chosen clinical indication and route of administration is crucial to ensure best performance and safety profile of the product. Size, size distribution, colloidal stability, surface composition and charge are among the key attributes defining the clinical fate of complex medicines. Another important aspect presented in the guide is the overall developability of the complex medicines. Certainly, scalability and reproducibility are critical to enable successful clinical translation of the carriers. Check out the MDC Connects slides and listen to Claire’s presentation to find out more.

SEDA offers a broad range of services including consultancy, laboratory and modelling for a range of therapeutics including complex medicines. More recently, SEDA has established laboratory services dedicated to complex medicines, with a view to further expansion of their current capability to support their growing client portfolio. To date, the SEDA team have successfully supported a variety of complex medicines projects, including peptidic, polymeric, inorganic and hybrid NPs for delivery of nucleic acids and other modalities including small molecules. We support our clients in their journey from discovery through to first dose in human and beyond. Activities we perform include, but are not limited to:

  • Due diligence assessment
  • Development of QTPP, proposed specifications and CQAs
  • Preparation of CMC development plan (including timelines and cost) to take the asset to FTiH
  • Delivery system design and characterisation
  • Participation in regulatory interactions including authoring of documentation
  • PK study design and data interpretation
  • Clinical pharmacology input to Phase 1 protocol and IND/IMPD
  • Developability/scalability risk assessment
  • Identification of CROs/CDMOs for GXP characterisation and/or manufacture

Find out more about our Complex Medicines capabilities and the expertise we can offer.