Analytical Method Development

Extensive analytical method development services for projects from pre-clinical through to late stage clinical manufacturing.

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analytical method development

Analytical Services

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 analytics team specialise in the development of analytical methods to protect quality throughout the programme.

Our model is built around:

  • One-site delivery for seamless project execution
  • Embedded senior leadership on every project
  • Scalable science that evolves with your programme
  • Flexible, responsive partnerships tailored to biotech needs

When you are ready to begin your CDMO journey, Upperton specialises in:

Inhalation drug products (pulmonary delivery)
Oral solid dosage form tablets and capsules
Oral solid dosage forms (OSD)
Nasal drug delivery systems
Parenteral formulations

Download our Analytical Method Development Case Study

Find out how we supported a dual API degradation project.

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 Method Development

Our Analytical Method Development Techniques Include

Upperton is home to an extensive number of analytical method development techniques. Please speak to our team directly to find the full list of our techniques.

01

Material Identification

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02

Solubility Screening

We use solubility screening to quickly identify how well a chemical compound dissolves in different liquids.

03

Excipient Compatibility

Excipient compatibility studies identifies early chemical or physical interactions between an API and inactive ingredients to protect drug safety, stability, and therapeutic performance.

04

Physico Chemical Characterisation

Physico chemical characterisation screening evaluates how different substances, materials and environmental factors interact with each other.

05

Enabling Platforms of Protocols Such as UpperSolvᵀᴹ, PulmoCraftᵀᴹ and UpperNoseᵀᴹ

Our specialist development platforms for nasal, pulmonary, and oral dosage forms.

Spray‑dried dispersions continue to be one of the most reliable technologies for enhancing the performance of poorly soluble drug candidates. Our team leverages decades of expertise to ensure each formulation is robust, scalable and tailored to the unique characteristics of your molecule."

Dr Richard Johnson

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

Why Upperton

At Upperton, we specialise in the formulation and development of complex molecules, supporting a wide range of advanced drug delivery systems.

Our expertise spans:

By combining scientific excellence with practical development expertise, we help overcome the challenges of complex drug products and accelerate their path to clinic and market.

partnership

Why Partner with Upperton

We provide fully integrated services across every stage of drug product development:

Microscope and analysis equipment at the Upperton facility

One Site

Integrated, end-to-end capabilities delivered under one roof.

Upperton scientist examining a formulation flask

One Team

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

Test tubes used in complex molecule formulation development

Complex Molecule Expertise:

Proven track record in solving formulation and delivery challenges.

Upperton senior leadership overseeing laboratory work

Executive Leadership on Every Project:

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

Let's work together

How can we help you?

Make an Enquiry About Us

Related Services

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 support a broad range of pharmaceutical products, including oral solid dosage forms, sterile formulations, biologics, peptides, small molecules and complex drug products. Our analytical strategies are tailored to the specific characteristics and development requirements of each molecule.

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.

Download Information Sheet

We provide fully integrated services across every stage of drug product development.

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