Prototype Formulation Studies

Accelerate your preclinical programme with Upperton’s integrated formulation, analytical and manufacturing expertise.

Why are Prototype Formulations Essential?

Prototype formulation studies involve the iterative development, testing, and refinement of product formulas wherein we can create a manufacturable, and stable sample prior to full scale manufacturing. This stage is essential in the pre-clinical development stage, in order to move from an initial concept into a tangible product, whilst also refining ingredients, texture, efficacy and development costs.

During our prototype formulation studies, our labs will typically create 3-5 different variations of a formulation for refinement purposes. This process ensures that we can refine key attributes, such as efficacy, patient friendliness, and appearance, after completing pre-formulation studies.

Speak to us about your prototype formulation studies

Learn how our subject matter experts can support your prototype formulation studies.

Move Your Molecule Forward

Key outcomes from your prototype formulation studies with Upperton

01

3-5 Different Formulation Variations

To reduce risk, we provide 3-5 different formulation variations, and discuss this with you extensively before choosing one and proceeding with your chosen route.

02

Available With Minimal API

Agile manufacturing to support early-stage clinical trials. Our team can support early feasibility with as little as 5mg of API, ensuring you recieve a full range of formulation variations with minimal API.

03

Adaptive, Tailored Approach

Upperton's model, facility, and expertise are designed to handle challenging molecules and demanding programmes. Our infrastructure and thinking are set up to manage complexity with flexibility.

Frequently asked questions

o   A prototype formulation is an initial, lab scale version of a product designed to test, evaluate, and refine a structure before full scale production.

Prototype formulations are typically developed during the early-stage development phase, immediately following the pre-formulation studies and initial concept definition and before preclinical in vivo studies.

After the prototype formulation has been developed, validation against the initial project requirements takes place. This involves comparing the prototype's performance against the initial product design specifications and objectives, gaining feedback from potential users, testing how the product is likely to interact with packaging materials, and evaluating the product against regulatory requirements.

Upperton is an end-to-end CDMO, able to work with clients from pre-clinical early feasibility studies, all the way through to late phase clinical manufacturing and commercial readiness. This provides us a unique insight as a company, in that we know the hurdles a pre-clinical molecule can run into at later phases, and have the experience to fix them before they derail timelines.

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

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