API Development at Primary Ingredients Pharma
Whilst small molecule pharmaceuticals continue to rise in complexity, working with your outsourced API development partner should remain simple. At Primary Ingredients Pharma, 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.
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 capabilities
API Manufacturing at Primary Ingredients Pharma
The rapid pace of innovation in small molecule development today calls for an equally dynamic approach to API manufacturing. With a 50+ year track record 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 program design and execution, and uphold the exceptional quality they should expect from a partner.
Our flexible and tailored approach to API manufacturing enables us to support even the most specialized and complex project requirements. Our facilities in the UK and US are equipped with state-of-the-art 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 temperatures, pressures, vacuums, and other technical demands.
Core to our API manufacturing capabilities are our dynamic facilities, which are well-equipped to support a broad range of technical requirements for active pharmaceutical ingredient manufacturing processes.
Our comprehensive facilities for API manufacture feature:
- 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 20 kg
- High potency capability of 10 – 100L for batch size up to 10 kg
- Broad range of intermediate and API trains from 200 – 14,800L scale
- Range of pressure filters, centrifuges and filter driers
- USP purified water system
- Cryogenic capability (-90°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
- Extensive range of capabilities including fluorination, hydroxylamine, organometallic, Friedel-Crafts and carbonylation
- Systems to deliver bulk Br2 Cl2 H2, ethylene oxide, propylene oxide
- Controlled substance manufacturing for Schedule I, II, III and IV