API Development

Pharmaceutical API development to accelerate your path to market

At Sterling we have extensive API Development capabilities ranging from route scouting and design, through to process optimisation and full validation support, including quality by design (QbD). As a PDMO, science is at the core of everything that we do and underpins our approach to API Development, coupled with our passionate commitment to service.

API Development at Sterling

Whilst small molecule pharmaceuticals continue to rise in complexity, working with your outsourced API development partner should remain simple. At Sterling, we pair true scientific collaboration with a 50+ year track record in complex and hazardous chemistry to support your molecule from discovery to commercial launch.

Our state-of-the-art facilities and expert teams are equipped to support even the most complex and challenging small molecules. Committed to providing our customers a simpler way of working together, we work closely with you to develop and optimise processes that best meet the unique needs and objectives of your project and your active pharmaceutical ingredient. ... Read more

With extensive expertise in quality, production, and engineering, as well as HSE, we can streamline your molecule’s path to market while delivering results in an efficient, scalable, innovative, cost-effective, and sustainable manner.

Our comprehensive API pharma development offerings include:

  • Robust medicinal chemistry services including supporting Drug Discovery through Lead Optimisation, Route Development, and Parallel and Custom Syntheses
  • A full range of process chemistry services including Proof of Concept (POC), Process Development, Quality by Design (QbD), and Design of Experiments (DOE)
  • 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
  • Unwavering focus on excellence and impeccable compliance record to support complex and hazardous chemistries with outstanding safety and sustainability
  • State-of-the-art development centres with over 70 chemists, small scale cGMP hydrogenation equipment, cGMP and non GMP kilo laboratories for clinical and commercial batches, and high potency capabilitiesRead less

Fast Facts

50+ year track record:

We apply over 50 years of proven expertise in API development to enhance your programme’s success.

Our facilities:

Located at centres of small molecule innovation in the UK and US, our facilities support a range of API development services.

Passionate teams:

Our experienced team of 150+ scientists are focused on collaborating with our customers to deliver timely and high-quality API development.

Breakthrough technologies:

Our partnerships with leading experts in emerging technologies enable us to apply innovative solutions to your API development programme.

High-quality process development

Reliable and robust processes are the foundation for delivering high-quality products. We work with our customers to identify and develop tailored processes that meet your project requirements while exceeding expectations for quality, safety, efficiency, and sustainability.  ... Read more

Our years of experience in API development enable us to deliver robust and scalable results, and our expertise in emerging technologies allows us to solve even the most complex chemistry challenges. All of this is supported by our passionate team of scientific experts and our commitment to placing our customers’ molecules at the centre of everything we do.

Our process development capabilities include:

  • Proof of Concept (PoC): We work with customers to determine the most suitable synthetic route and establish a clearly defined path to success.
  • Process Optimisation: We ensure processes are robust and suitable for scale-up, using theoretical tools such as Britest to drive process understanding and risk profiling.
  • Quality by Design (QbD) and Design of Experiments (DoE): We generate experimental evidence of critical process parameters to ensure repeatable quality while mitigating risk.
  • Technology Transfer (TT): We simplify and reduce the risk of TT by working in a transparent and collaborative way with our customers.
  • Synthesis of analogues, reference standards, metabolites, impurities, and stable radio labelled compounds. Read less

Robust analytical services

Ensuring the quality and reliability of every method requires extensive analytical expertise. With a highly experienced team of analytical scientists and a full selection of specialised equipment, we have the capability to develop, test and validate analytical methods to support robust product release and successful regulatory submissions. ... Read more

Our team’s commitment to compliance and vast knowledge of regulatory requirements enable us to provide analytical methods and results that stand up to even the toughest scrutiny. We deliver a comprehensive range of analytical services that are tailored to each stage of development throughout your entire programme.

Our suite of analytical services includes:

  • Analytical method development and qualification
  • Existing method validation, testing, and transfer
  • Documentation, analysis, and reference standard management
  • Regulatory submission support
  • Elemental, PGI, nitrosamines risk assessment and analysis
  • LCMS, GCMS, XRPD, ICPMS, and NMRRead less

Technological innovation

Through our Technology and Innovation Programme, we work closely with academic and technology institutions to explore innovative solutions for our customers’ API development challenges. We identify technologies that deliver the greatest value to our customers, and continually develop our capabilities in these areas to help them remain at the forefront of industry innovation. This programme has ensured we have made key investments in biocatalysis, continuous manufacture, and more.

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About Us

PDMO

Service. Passion. Science.