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2. About Quay Pharma Provider of contract development and manufacturing services to the pharmaceutical and healthcare industries Based in the United Kingdom Founded in 2002 Global client reach Privately owned, financially secure

3. Quay People Quay has 45 employees, with majority dedicated to supporting customer projects Cross functional formulation development, analytical and manufacturing team Flexibility Responsiveness Dedicated project managers to deliver client projects

4. Professor Mike Rubenstein (Founder and Chairman) Over 40 years experience in solid dosage form design, development and manufacture Chemical engineer and pharmacist with QP status Industrial background in R&D and production at GSK and AZ Prof. of Pharmaceutical Technology and Director of the School of Pharmacy and Chemistry at LJMU Author of five books and over 200 original research papers in Pharmaceutical Technology in solid dosage development and controlled drug delivery Professor John Collett (Chief Scientific Officer) Professor of pharmaceutics at Manchester University World authority on polymeric drug delivery with over 30 years formulation science experience Author of over 250 research papers Specialist areas of expertise include; formulation of solubilised systems development of modified release drug delivery systems improving oral bioavailability of poorly water soluble drugs

5. How we can help Solving complex drug development challenges Overcoming challenging physiochemical properties of APIs Improving performance of existing products Providing safe, robust products for clinical trials Manufacturing services for wide range of dosage forms Effective management of clients projects

6. Quay Services

7. Expertise with broad range of dosage forms tablets capsules multiparticulates topicals oral liquids parenterals

8. Multi-faceted approach to solving solubility and bioavailability challenges lipidic systems solid dispersions pH control particle size reduction solubilising agents

9. Drug Delivery Expertise Controlled release tablets Multi-particulate technologies Modified release microparticles Semi-solids in capsules Coating technologies Permeation enhancing technologies

10. Renowned Analytical Services Quay has excellent track record in developing robust analytical methods for wide range of compounds Method development and transfer Forced degradation studies Formulation development support Stability studies QC testing

11. Manufacturing Expertise GMP manufacture of broad range of non-sterile dosage forms First in Man studies including XcelolabTM Phase I/II clinical manufacturing Small scale Phase III manufacturing Specials Manufacturing Potents / Cytotoxics

12. Reliable Supply of Products for Clinic or Market Bulk packing of tablets or capsules Small scale blister packing Individual patient packs Global distribution of clinical supplies

13. Regulatory Status Manufacturers Authorisation for Investigational Medicinal Products (IMPs) Specials manufacturing licence Regular audits by clients and the UK regulatory authority (MHRA) Registered as a manufacturing site with the FDA

14. CASE STUDY 1: Bioavailability Enhancement Using Lipidic Systems CLIENT: UK Based Pharma Company THE BRIEF: Oncology Treatment Poor aqueous solubility Bioavailability enhancement needed to progress drug OUR SOLUTION: Solubility screening and optimisation Two lipid based formulations developed Dog PK study performed Dosage levels subsequently reduced Drug licensed to major pharma

15. CASE STUDY 2: Flexible Targeted Delivery System CLIENT: German Pharma Company THE BRIEF: New indication for existing product 3 Phase delivery required Immediate release in stomach (IR) Delayed release in small intestine (DR) Modified release in small intestine (MR) Flexible dosing required OUR SOLUTION: Mini-tablet system developed(