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OUR CONTRACT PHARMACEUTICAL SERVICES

Company Overview

PRECLINICAL FORMULATION SCREENING

We create robust formulation development strategies tailored to the characteristics of each individual API.

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Quay Pharma enjoys the opportunity to engage with our clients as early as possible to create robust development strategies tailored to the characteristics of each individual API.

To that end, Quay Pharma can complement the drug discovery process by optimising dosing formulations ahead of efficacy, pharmacokinetic and toxicological preclinical studies by assessing solubility and short-term stability using minimal API. Utilising a rapid turnaround and cost-effective screening platform, the selection of solvents and/or excipients will be tailored to the individual API depending on critical factors such as indication, route of administration and intended species. By optimising formulation at this stage, bioavailability profiles can be improved and the exposure levels achieved during toxicology studies can be enhanced.

We can incorporate rodent PK assessment for formulation comparison and PK/dose prediction modelling by working closely with our preferred partners.

In addition to optimising formulation ahead of preclinical studies, these screens are equally helpful in fast-tracking re-formulation for bioequivalence studies when an API is to be trialled for a new indication or different patient group (e.g. paediatrics). In addition to solubility and stability screening, gap analysis assessments can be performed, reviewing any work performed to date along with literature data in order to propose a theoretical formulation and analytical development strategy based on the properties of the API and intended use.

Quay Pharma's Preclincal Capabilities

  • Tailored Solvent & Excipient Selection
  • Bespoke Solubility Assessment
  • Short-term Stability Evaluation
  • Rodent PK assessment (with partners)
  • PK modelling/dose prediction (with partners)
  • Minimal API required
  • Rapid Turnaround
  • Cost-Effective

Our Partners

When moving along the preclinical drug development pathway, it is important to consider multiple factors in addition to the formulation, such as the DMPK profile. To that end, we work with experts in the field of DMPK characterisation who can ensure your molecule’s DMPK profile is suitable to underpin not only your preclinical studies but also for moving into first in human (FIH) studies. If any data gap filling is required, these studies can be performed in parallel with our preclinical formulation optimisation to progress development as quickly as possible from a solid scientific foundation.

Put Your Project In The Hands of Quay Pharma
David Humphreys
Head of Account Management & Preclinical Business Development
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Originally joining in 2005 David has over 15 years experience within Quay, predominately within a commercial role and a deep understanding of Quay’s services and Quay’s customers values’. David has also previously worked for Merck KGaA within the supply chain for excipients and after re-joining Quay, Heads up Account Management and Pre-clinical Business Development. David has a background in analytical chemistry and a MSc in Applied Pharmaceutics.

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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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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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