Quay pharma company presentation

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Overview of company and services at Quay Pharma. Last updated August 2013

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Quay pharma company presentation

  1. 1. Page Break 2 + Strap line
  2. 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. 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. 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. 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 client’s projects
  6. 6. Quay Services
  7. 7. Expertise with broad range of dosage forms tablets capsules multiparticulates topicals oral liquids parenterals
  8. 8. Multi-faceted approach to solving solubility and bioavailability challenges lipidic systems solid dispersions pH control particle size reduction solubilising agents
  9. 9. Drug Delivery Expertise Controlled release tablets Multi-particulate technologies Modified release microparticles Semi-solids in capsules Coating technologies Permeation enhancing technologies
  10. 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. 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. 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. 13. Regulatory Status Manufacturer’s 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. 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. 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(<0.3mm)  Central core with three different polymer coatings  Low cost, scalable solution  Ideal for rapid clinical evaluation
  16. 16. CASE STUDY 3: Bioavailability Enhancement Using Lipidic Systems CLIENT: UK Based Pharma Company THE BRIEF: • Anti-infective • Poor aqueous solubility & bioavailability • Limited funds for development OUR SOLUTION:  Range of options explored  Lipidic system  Micronised API (dry powder)  Solid suspension  Solid suspension  improved BA  no intra-patient variability Drug progressed to Phase I, IIa and IIb 0 2000 4000 6000 8000 0 5 10 15 20 25 Plasmaconc.(ng/ml) Time (hours) PK study in dogs Solid suspension Dry powder
  17. 17. CASE STUDY 4: Novel Drug Delivery System for HIV Prevention CLIENT: Non-Profit US Corporation THE BRIEF: • Intra vaginal administration • Fast acting microbiocide • Low cost treatment required • Non-irritating to vaginal mucosa OUR SOLUTION:  Vaginal pessary developed  Rapid gel formation (under 2 minutes)  Mucoadhesive properties  Exceeded client requirements  IP developed and patents filed by client
  18. 18. CASE STUDY 5: Compaction Simulation to Overcome Manufacturing Problems CLIENT: Actavis THE BRIEF: • Anaemia Treatment • Tablet product • Unable to meet specification after moving production process OUR SOLUTION: Compaction simulation used to compare processes Various parameters evaluated: punch dimensions, compression force, dwell time and press speed Advised client on new tooling required Product successfully transferred
  19. 19. The Quay Advantage Client focused Scientific expertise Non-IP technologies Flexibility Problem solving ability Tailored approach
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