As small molecule complexity continues to rise, our global facilities offer our customers the scientific and engineering expertise they need to develop and deliver scalable and innovative solutions for active pharmaceutical ingredient (API) manufacture, from preclinical to commercialisation.
Fast Facts
>800m3 total reactor volume and vessels >13,400L in a wide range of materials of construction to support your project needs.
Last year we produced >700,000kg over >2,000 batches across our network.
GMP campaigns ranging from <1kg to >300MT per year.
Typical containment levels for manufacturing 1mg/m3, with specialised containment <1ng/m3.
Cryogenic capacity to 6,000L at temperatures <-95°C.
Hydrogenation capacity from 10L-6,300L at a pressure range from 4 psig/0.28 bar-1,000 psig/69 bar.
API Manufacturing Capabilities at Sterling
The rapid pace of innovation in small molecule development today calls for an equally dynamic approach to API manufacturing.
With 50+ years as a leading small molecule API manufacturer, we combine our team’s scientific and engineering expertise with close collaboration to:
- Help our customers solve complex challenges in the manufacturing process
- Maintain a secure supply chain and transparency through every stage of programme design and execution
- Uphold the exceptional quality they should expect from a partner as a project moves through to commercialisation
Our flexible and tailored approach to pharmaceutical production enables us to support even the most specialised and complex project requirements, as well as technology transfer into and across our global network of facilities. ... Read more
Our comprehensive facilities for API manufacture feature:
Our sites in the UK, US and EU are equipped with the API manufacturing equipment to support a wide range of project requirements. We have the capabilities and expertise to offer our customers manufacturing support for a wide range of temperatures, pressures, vacuums, and other technical demands.
- Hydrogenation capacity from 10L to 6,300L at a pressure range from 4 psig/0.28 bar to 1000 psig/69 bar
- cGMP kilo laboratory facilities at 10, 20, 25, 50, 100 and 200L for clinical and commercial GMP campaigns ranging from <1kg to more than 300 MT
- High potency capability of 10 – 100L for batch size up to 10 kg with specialised containment down to <1ng/m3
- Vessels from 200L up to 13,400L in a wide range of materials of construction to support your chemistry and product needs
- Range of pressure filters, centrifuges and filter driers
- USP purified water system
- Cryogenic capacity from 1,500 to 6,000 litres (-95°C)
- High temperature capability (+200°C)
- High vacuum WFE/SPE unit and fractionating unit with 30 theoretical plates
- Hydrogenation vessel from 10 – 4500L scale
- Range of milling facilities in cleanroom environment
- Peptide manufacturing with columns offering 50L and 170L capacity
- Extensive range of capabilities including fluorination, hydroxylamine, organometallic, Friedel-Crafts and carbonylation
- Systems to deliver bulk Br2 Cl2 H2, ethylene oxide, propylene oxide
- Controlled substances manufacturing for Schedule 1-5 (UK) and Schedule I-V (US) Read less
Fast Facts
50+ year track record:
We have been a leading small molecule API manufacturer for more than 50 years.
Global API manufacturing facilities:
Our network of facilities include API manufacturing sites in the UK, US and EU and are equipped to support a diverse range of requirements.
Specialised capabilities:
We are capable of handling highly specialised API manufacturing programmes, supporting fluorination, hydroxylamine, HPAPIs, organometallic, Friedel Craft, carbonylation, and more.
Outstanding safety and compliance:
We uphold stringent HSE standards in line with our ZeroHarm initiative to ensure that products are produced safely for both people and planet.
Our API manufacturing facilities
Repeatable quality at scale
In a highly regulated industry, it is critical to ensure the safety and quality of your products and processes, as well as that of the patients these drugs will eventually help.
Our quality team ensures that your product’s manufacturing processes adhere to cGMP standards throughout the entire product lifecycle. They are also responsible for making sure that all manufacturing processes are carried out correctly and as planned, while adhering to our customers’ desired timelines. ... Read more
As a leading API manufacturing company, we have a deep knowledge of regulatory requirements around the world, and our facilities have undergone successful cGMP inspections including with the FDA, MHRA and PMDA. We have supported our customers in their regulatory filings for many years, including compiling data on our customers’ behalf for CMC submissions.
Seamless process design and commercial API manufacturing
Scaling up an API from small to commercial-scale batches is highly complex, bringing about an entirely new set of process and safety considerations.
Our operations and engineering teams have extensive experience scaling our customers’ products from grammes to tonnes, while maintaining the highest standards of quality and safety along the way. ... Read more
We are dedicated to providing our customers full-lifecycle support, from discovery through to commercialisation. Our New Product Introduction (NPI) team and processes ensure the successful transfer of your product from the lab to the production plant. We offer comprehensive services in API development and manufacturing with, flexibility, transparency, and quality. Read less
Expert engineering teams
Our engineering team has extensive expertise in working with customers to overcome complex challenges and deliver repeatable and scalable quality in API manufacturing. Each customer project is assigned a dedicated process engineer to ensure streamlined communication every step of the way. ... Read more
Our engineers work closely with our customers and our chemists to develop tailored, flexible engineering solutions and successfully bring projects from the lab to a commercial scale on plant. Our multi-disciplinary team is widely known among our customer base for its deep experience, commitment to transparency, and passion for customer success. Read less
Comprehensive hazard evaluation
We know that as the scale of a project increases, so does the potential for hazard. We have over 50 years of experience in hazardous chemistry, and we adhere to stringent safety standards in all of our API manufacturing processes.
Our hazardous chemistry services are supported by a hazard evaluation laboratory where we integrate our process engineering and chemistry expertise to ensure the safety and success of your project. ... Read more
Committed to protecting our people and our planet, we carry out robust hazard evaluation at the onset of every manufacturing project and ensure the proper safeguards and engineering controls remain in place throughout its entirety.
Our hazardous chemistry expertise enables us to safely scale up reactions involving diazomethane, HPAPIs, chlorination, bromination, hydrogenation, and much more.
Click to read more about our hazardous chemistry capabilities. Read less
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