Analytical Method / Formulation Development

Quay Pharmaceuticals

Based in purpose built facilities in the North West of England, Quay Pharmaceuticals Limited provides a comprehensive outsourcing service for the development and testing of pharmaceutical products. Quay Pharma has particular expertise in oral dosage form design and development, in particular novel drugs that exhibit poor solubility and bio-availability.Services include:

Pre-Formulation and Formulation Development Servicesmore

Pre-formulation servicesIncluding particle size and surface area determinations, stability assessments, polymorphic characterisation and drug-excipient interactions. 

Quay Pharmaceuticals also offer formulation development expertise in:

  • Conventional and controlled release tablets and capsules
  • Liquid / semi-solid fill capsules
  • Parenteral formulations
  • Liquid / semi-solid formulations (e.g. creams and gels)

Contract Analytical Services and Analytical Method Development

Manufacture of clinical trial supplies

The clinical manufacturing facilities at Quay Pharmaceuticals operate to GMP standards.  Quay holds IMP licence and a 'Specials Manufacturing Licence'. Manufacturing scale averages 1 – 20kg which is normally sufficient to support Phase I – II clinical studies.

Production technologies include:

  • High-shear mixers / granulators
  • Planetary mixers
  • Fluid bed processors
  • Single punch, bilayer and high-speed rotary tablet presses
  • Tablet-coating facilities for film, and enteric coating
  • Bench top and automatic capsule filling equipment for powders, granules, liquids and semi-solids
  • Tablet / capsule check weigher
  • Topicals manufacturing facilities
  • High-shear mixer / homogeniser for liquids and suspensions
  • Manual liquid filling capabilities
  • Comparator-blinding services, including encapsulation and coating
  • Placebo development for use in blinded studies

Pharmaceutical Research Personnel

Pharmaceutical Dosage Form Design

Professor Mike Rubinstein (CEO) has over 30 year’s academic and industrial experience (with AstraZeneca) in Pharmaceutical Dosage Form Design, Development and Manufacture.  Professor Rubinstein is both a Chemical Engineer and a Pharmacist with QP status and was previously Director of the School of Pharmacy and Chemistry at Liverpool JMU in the UK.  He a well established internationally recognised academic (with over 200 original papers published) in pharmaceutical technology.

Modified Release Drug Delivery Systems

Professor John Collett (Chief Scientific Officer) also has over 30 years academic and industrial experience in Pharmaceutical Dosage Forms with particular emphasis on the design of modified release drug delivery systems and methods to enhance oral bioavailability of poorly water soluble drugs.  Professor Collett has been a consultant for a large number of international companies and has published over 250 original research papers centred around modified and controlled release dosage forms.  He is a leading world authority on polymeric drug and was formerly Professor of Pharmaceutics at the University of Manchester.

Clinical Trials Manufacturing and Quality Management Systems

Jill Jones (Operations Manager).  Jill has nearly six years experience in implementing and maintaining quality management systems including reviewing batch manufacturing records, standard operating procedures and validation documentation within the pharmaceutical industry.  Before joining Quay she previously had ten years industrial experience in formulation development and production support roles with BASF - Super Absorbent Polymer Diversion and Bristol Myers-Squibb clinical trials manufacturing unit.

Formulation Development

Mike Frodsham (Pharmaceutical Development Manager). Mike is Quay’s Pharmaceutical Development Manager responsible for all Formulation Development activities.  Mike has previously worked for Galpharm International, involved in product development and technical transfer of products from sites in the UK out to manufacturing sites in India; prior to this, as Principle Scientific Officer at SSL International responsible for the formulation development team.

Sample Preparation, Chromatography and Mass Spectrometry

Dr Mark Powell (Analytical Manager)is responsible for developing new test methods and producing data to support the regiuay

stration of new drug products.  Analytical data is necessary to support formulation development activities, and to assure the safety of drug products intended for CT use.  Mark has previously worked for Hyder Consulting, developing methods for very low levels of organic compounds in a variety of sample types, and as a Senior Lecturer at Liverpool John Moores University.  His particular areas of expertise are sample preparation, chromatography and mass spectrometry



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Quay Pharmaceuticals
Quay House, 28 Parkway, Deeside Ind. Park
CH62 2NS, Mold
United Kingdom

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