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Analytical Method Development

Upperton offers extensive analytical method and validation services as part of our development services as well as stand-alone analytical testing services for projects throughout each stage of the drug life cycle from pre-clinical through to late phase. Our analytical scientists develop and validate methods that support product quality, stability, regulatory compliance and clinical progression.

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Analytical Method development

Analytical Research and Development

Our team have access to a wide range of techniques to support your project.

Successful development programmes begin with a thorough understanding of the physio-chemical characteristics of the API. Additionally, it is important to understand any potential stability or excipient incompatibility challenges.

Using a range of techniques including DSC, TGA, XRPD, Microscopy, FTIR, Particle sizing etc, we gain a fundamental understanding and insight into the behaviours of your API to support the development activities required for first in human studies and product development.

Analytical & Characterisation Capabilities

Traditional Methods

  • HPLC
  • Dissolution
  • Spectrophotometric Analysis
  • FTIR
  • Karl Fischer

Physical Characterisation

  • Laser Particle Sizing
  • Electron Microscopy
  • Differential Scanning Calorimetry
  • X-Ray Diffraction
  • Dynamic Vapour Sorption
  • Powder Rheology

Dosage Form Testing

  • NGI Powder Deposition (Pulmonary)
  • AIVI Deposition (Nasal)
  • Nasal Spray Characterisation
  • Dissolution Testing (Biorelevant & Traditional)

Biologics

  • Gel Electrophoresis
  • Western Blotting
  • ELISA
  • Spectrophotometric Analysis
  • Sub-Visible Particulates

Analytical Method Development

Analytical and Quality Control Services

Once a product enters clinical development, our dedicated analytics team work with you, and with the cross functional teams in our business. We then transfer, develop and create phase appropriate validation of your analytical methods and performance of QC and release testing. This includes:

01

Assay, content uniformity and related substances by HPLC

02

Performance testing including dissolution and disintegration

03

Moisture and residual solvents

04

IC stability testing

05

Cleaning verification

YOUR STRATEGIC CDMO PARTNER

Partner with Upperton

We provide fully integrated CDMO services across every stage of the drug product lifecycle.

One Site

Award-winning facility built for scale and continuity providing integrated, end-to-end capabilities delivered under one roof.

One Team

The same team from your early-stage development through to preparation for commercial readiness.

Dosage Form Expertise

Proven track record in solving formulation and delivery challenges across multiple dosage forms.

Executive Leadership on Every Project

Direct access to experienced senior leadership for strategic oversight and decision-making.

Related Services

Related Content

Analytical FAQs

Reliable analytical methods are essential for generating accurate data, understanding product characteristics, ensuring quality and supporting regulatory compliance. Early investment in robust method development can reduce development risks, prevent delays and facilitate smoother progression through clinical and commercial stages.

We recognise that every molecule and development programme is unique. Our team develops customised analytical approaches based on your product attributes, regulatory requirements, development phase and long-term commercial objectives.

Speak to us about our analytical method development services

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