We provide first-class development services using both our state-of-the-art equipment and our experts’ insight to meet customers’ API project requirements – from early phase development to commercialisation, we accelerate products to market.
Our small molecule API development facilities can support the development of even the most challenging molecules. We combine health, safety and environment (HSE), quality, production and engineering expertise to ensure we deliver efficient, innovative and sustainable results that are cost-effective from the outset.
Our experienced team of over 70 scientists can develop new processes or optimise existing ones to ensure the most efficient synthetic process is implemented in a robust and scalable way.
From our dedicated development centre, our offering includes:
- 32 fume hoods
- 10L and 30L small scale cGMP hydrogenation equipment
- cGMP kilo laboratory facilities at 10, 20, 25 and 50L for clinical and commercial API batches up to ~5kg
- High potency capability of 10L and 20L
- DoE and QbD support services
- Multi-block reactors and process intensification
- Flow chemistry capability
- Medicinal chemistry services including drug discovery, lead optimisation, route development and parallel and custom synthesis
- Optimisation and scale-up of existing processes
- Identification and development of new processes
- Full range of supporting and analytical services including LCMS, GCMS, XRPD, ICPMS and NMR
- Analytical method development, validation and transfer
- Support for regulatory submissions
Proof of Concept (POC)
We offer a POC service to our customers to determine the feasibility of a synthetic route and provide our customers with a clearly defined pathway to success.
Quality by Design (QbD) and Design of Experiments (DoE)
We apply our QbD and DOE approaches to generate experimental evidence of critical process parameters and ensure the production of a consistently high-quality product while mitigating risk.
Our significant technology transfer (TT) experience allows us to efficiently scale-up our customers’ projects from grams to tonnes. Our global, integrated facility network allows us to offer a swift and streamlined TT process from early phase through to commercial batch production.
We offer a range of drug discovery services including new route development and lead optimisation from our US facility.
We offer a comprehensive range of supporting analytical services to underpin the success of your development programmes. Our scientists deliver robust, transferable methods that are tailored to your phase of development.
Our services include:
- Method development and method qualification
- Validation and transfer
- Elemental risk assessment