OUR CONTRACT PHARMACEUTICAL SERVICES

Company Overview

PHARMACEUTICAL PREFORMULATION & ANALYSIS

Essential early stage evaluation of a new drugs physicochemical properties.

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At Quay Pharma, we are highly experienced in preformulation and analysis of Active Pharmaceutical Ingredients (APIs), including those that present particular challenges.

We regularly help early stage companies evaluate their new drug’s physicochemical properties, carrying out the essential groundwork for optimising the formulation and delivery method.

We can then create an appropriate product for your needs, whether you require a fit-for-purpose formulation for initial preclinical safety and efficacy testing or a formulation strategy designed to help your drug progress into clinical use.

Our Extensive Preformulation Capabilities Include:

  • API stability profiling (including an evaluation of the effects of heat, light, and pH).
  • Solubility profiling in buffers and non-aqueous solvents, and determining the partition coefficient of an API.
  • Compatibility testing of APIs and excipients.
  • In vitro diffusion studies using Franz cells with synthetic and/or biological membranes.
  • Rheology and viscoelastic preformulation studies of liquids, creams and gels.
  • Specific gravity testing.
  • Informal stability/formulation stress testing (both physical and chemical).
  • Formulation and packaging compatibility studies.
  • Tablet compaction analysis.
  • Powder formulation investigations using an Xcelolab™ powder dispenser for method development, powder dispense head selection and powder characterisation studies.
  • Parenteral formulations for early phase toxicity evaluation.
  • Management of characterisation services such as, but not limited to, particle size, DSC, TGA, powder X-ray diffraction, FTIR and particle morphology.
  • Writing CMCs and other regulatory documents for product registration with the MHRA, FDA and EMEA regulatory bodies.
  • Supply of liquids, mini-capsules and mini-tablets for use in animal studies.
Your Dedicated Contacts
Mike Frodsham
Chief Technical Officer
(CTO)
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Mike has over 20 years’ experience in drug product development. For over 15 years he has been responsible for development activities at Quay Pharma. During this period Mike has overseen over 200 non-sterile development projects; predominantly taking NCE’s through to first in human studies and beyond. His background is in formulation science with a PhD in liquisolid dosage forms and is cited as an inventor on multiple oral formulation patents.

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Dr Alison Foster
Head of Technical
(Preclinical)
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Alison is the Head of Technical for Preclinical Services at Quay Pharmaceuticals. She has a wide breadth of experience having worked previously for Unilever in their cross-category research unit focused on Oral Care and Hair projects, to being one of the founders of a small nanotechnology start-up company focussed on improving bioavailable of poorly soluble drugs. Alison gained Post-Doctoral experience in medicinal chemistry from the School of Pharmacy, the University of Manchester following a PhD in synthetic chemistry. Alison is also co-author of twenty-five patents and nine papers.

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Our Pharmaceutical Services

Preclinical Formulation

Robust formulation development strategies tailored to the characteristics of each individual API.

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Pharmaceutical Preformulation

Analysis of Active Pharmaceutical Ingredients (APIs), including those that present particular challenges.

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Pharmaceutical Formulation Development

Dosage form optimisation for a wide range of product types including those that have poor solubility or bioavailability.

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Analytical Services

Analytical specialists working alongside our formulation and manufacturing teams which provide expert advice.

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Phase I Clinical Manufacturing

Early clinical formulations and clinical manufacturing of First in Human trials and clinical evaluations of your API.

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Phase II & III Clinical Manufacturing

Fully equipped and accredited to manufacture a wide range of products for Phase II and small-scale Phase III trials.

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Commercial Manufacture & Packaging

MHRA licensed to include commercial manufacture. Services include contract packaging and assembly...

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Controlled Substances

Over ten years of extensive development and manufacture experience converting controlled substances into a variety of different dosage forms.

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Clinical Trial Supply

Complete range of clinical trial supply packaging for solid and liquid dosages. Despatched with full QP release certification.

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Live Biotherapeutics Drug Delivery

One of the few companies licensed for the clinical manufacture of live biotherapeutics products.

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Orphan Drugs

Perfectly equipped to deliver an Orphan Drug molecule from preclinical and formulation development to small scale commercialisation.

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Specials Manufacturing

One of the limited number of contract manufacturers who hold an MRHA license for the manufacture and supply of ‘specials’.

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Let's Talk Project Success

Talk directly to the Quay staff - Our dedicated team leaders are ready to listen and help with your project.

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