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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

Quay People

Quay has 50+ employees, with majority dedicated to supporting customer projects

Cross functional formulation development, analytical, QC and manufacturing team• Flexibility • Responsiveness

Dedicated project managers to deliver client projects

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 at The University of Manchester• 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

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

Quay Services

Expertise with broad range of dosage forms

tablets capsules multiparticulates

topicals oral liquids parenterals

Drug Delivery Expertise

Modified release tablets

Multi-particulate technologies

Modified release microparticles

Semi-solids in capsules

Coating technologies

Permeation enhancing technologies

Multi-faceted approach to solving solubility and bioavailability challenges

lipophilic systems

solid dispersion systems

micro-environmental pH control

particle size optimisation

solubilisation

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

Manufacturing Expertise

GMP manufacture of broad range of non-sterile dosage forms

• First in Man studies including XcelolabTM

• API in vial/bottle for reconstitution • Phase I/II clinical manufacturing• Small scale Phase III manufacturing• Specials Manufacturing• Potents / Cytotoxics

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

Regulatory Status

Manufacturer’s Authorisation for Investigational Medicinal Products (IMPs)

• potents• cytotoxics• controlled drugs

Specials (unlicensed medicines) manufacturing licence

Regular audits by clients and the UK regulatory authority (MHRA)

Registered as a manufacturing site with the FDA

CASE STUDIES

CASE STUDY 1:Bioavailability Enhancement Using Lipidic Systems

CLIENT: KuDos/AstraZeneca

THE BRIEF:• Oncology Treatment (PARP inhibitor)• Poor aqueous solubility• Bioavailability enhancement needed to • progress drug

OUR SOLUTION: Solubility screening and optimisation Two lipid based formulations developed Dog PK study performed Dosages subsequently reduced Drug licensed to AZ and in Phase III

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 3 different coating options Low cost option with scalability Ideal for rapid clinical evaluation

CASE STUDY 3:Bioavailability Enhancement Using Lipidic Systems

CLIENT: Idenix – now licensed to GSK

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 bioavailability no intra-patient variability

Drug progressed to Phase I, IIa and IIb

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PK study in dogs

Solid suspensionDry powder

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CASE STUDY 4:Novel Drug Delivery System for HIV Prevention

CLIENT: NYBC/Gates Foundation

THE BRIEF:• Intra vaginal administration• Fast acting microbicide• 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

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 processesVarious parameters evaluated: punch dimensions,

compression force, dwell time and press speedAdvised client on new tooling requiredProduct successfully transferred

CASE STUDY 6:

CLIENT: MediWound

•THE BRIEF:•Non traumatic to patient•Gel to provide delivery of microspheres over 48 hours•Be gas permeable and not hermetically seal the wound•Be terminally sterilised

OUR SOLUTION (– Still in development)Thermally reversible gelMultiple combination polymer system for

Content uniformity Maintain negative charge on beads

We are currently understanding the requirement to cope with varying levels of exudate in wounds

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R2 = 0.8918

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Release of beads to from gel over 7 hours. Using a Franz cell assessment

Release of beads to from gel over 7 hours. Using a Franz cell assessment

The Quay Advantage

Client focused

Scientific expertise

Non-IP technologi

esFlexibil

ity

Problem solving ability

Tailored approach

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