Small molecule overview
Small molecule development and manufacturing services spanning the full molecule lifecycle
Sterling provides full-service API development, scale up and cGMP contract manufacturing services from grams to tonnes. In addition, we provide antibody drug conjugate (ADC) development and clinical manufacturing services from our dedicated bioconjugation facility in Deeside, Wales.
For more than 50 years, we have delivered comprehensive small molecule API development and manufacturing solutions to leading pharmaceutical and biotechnology organisations, empowering our customers to overcome their most complex scientific challenges and enhance value. Our technical expertise positions us as an ideal partner to maximise your project’s success throughout its lifecycle.
A look at our small molecule capabilities
As a partnership development and manufacturing organisation (PDMO®), we aim to be so much more than a traditional contract development and manufacturing organisation (CDMO). We are committed to working with you closely to develop efficient processes, maximise effectiveness and ensure scalable and repeatable results, together.
We have extensive capabilities ranging from route scouting and design, through to process optimisation and full validation support, including quality by design.
Working in collaboration with our university and industry partners, we provide our customers direct access to specialised expertise and the technologies that hold the greatest potential for their projects, through our dedicated Technology and Innovation Programme. Our technological expertise extends to biocatalysis, flow chemistry, hazardous chemistry, high potency APIs and much more.
We deliver the technical expertise needed to develop and deliver scalable and innovative solutions, from preclinical to commercialisation.
Including solid state chemistry and milling and micronisation to optimise your API, and CMC support to guide you through the regulatory landscape, these services are available as part of an integrated or standalone offering.
Our facilities
Our network of facilities provides customers with a wide range of capacity and capability options. The teams at all locations work closely together to provide the most appropriate solutions for customer projects, developing project plans that make best use of our resources and considering all customer requirements.
This facility offers API development and manufacturing services with specialist expertise in peptide manufacturing and large scale chromatography.
Our teams at this site specialise in hazardous chemistry and provide a wide range of API cGMP and non cGMP manufacturing services from a smaller scale in our pilot plant and kilo labs to full scale commercial manufacturing. The site houses our dedicated Material Science Centre and bioplant.
This facility delivers extensive research and development expertise including support to early phase small molecule projects.
Situated close to the Research Triangle Park, this facility specialises in delivering chemistry solutions for preclinical and early phase clinical trial material, catering for volumes from millilitres to 200 litre batches.
This facility has a wide range of technologies including plant scale hydrogenation and cryogenics. It possesses all the requirements to provide API clinical and commercial phase manufacturing services, including high potency API manufacturing.
What will a partnership with Sterling bring to your project?
With over 50 years’ experience, Sterling understands the importance of partnership and the critical role full transparency plays in supporting your project through development and manufacturing.
- Robust medicinal chemistry services including supporting drug discovery through lead optimisation, route development, and parallel and custom synthesis
- Full range of process chemistry services including proof of concept (POC), process development, design of experiments (DOE) and quality by design (QbD)
- Comprehensive supporting analytical services including LCMS, GCMS, XRPD, ICPMS and NMR
- Global integrated facility network to enable seamless technology transfer (TT) and close collaboration between scientific teams
- Our facilities have undergone successful cGMP inspections with the FDA, MHRA, PMDA and more
- 10L and 20L small scale cGMP hydrogenation equipment
- cGMP kilo laboratory facilities at 10, 20, 25, 50, 100 and 200L for clinical and commercial API batches up to 20kg
- High potency capability of 10 – 100L for batch size up to 10kg
- Extensive range of capabilities including fluorination, hydroxylamine, organometallic, Friedel-Crafts and carbonylation
- Controlled substance manufacturing for Schedule I, II, III, IV and V
