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OUR CONTRACT PHARMACEUTICAL SERVICES

公司概述

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.

为此目的, 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. 儿科). 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

  • 定制的溶剂 & 赋形剂的选择
  • Bespoke Solubility Assessment
  • Short-term Stability Evaluation
  • Rodent PK assessment (with partners)
  • PK modelling/dose prediction (with partners)
  • 所需API最少
  • 快速周转
  • 具有成本效益的

我们的合作伙伴

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. 为此目的, 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.

Our Pharmaceutical 服务

Drug Development 服务

SGS PACE (Product Accelerated Clinically Enabled) helps you bring the vision of your new drug to life - Faster.

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临床前制定

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

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处方前工作

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

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Pharmaceutical 制定发展

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

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分析服务

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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二期 & III Clinical Manufacturing

Fully equipped and accredited to manufacture a wide range of products for 二期 and small-scale 二期I trials.

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商业生产 & 包装

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

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受控物质

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

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临床试验供应

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

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住Biotherapeutics Drug Delivery

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

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孤儿药物

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

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特殊制造

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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