Late-Stage Clinical and Commercial Manufacturing
Your Global CDMO Partner for Late-Stage Manufacturing
Having a trusted and flexible partner is essential to help overcome the challenges of manufacturing at scale and meeting the needs of different markets and regions. Pharmaron operates as a Contract Development and Manufacturing Organization (CDMO) providing API manufacturing from late-stage clinical development to commercial supply tailored to phase, project and client needs.
We recognise that service and product quality, speed of delivery and reliability are essential elements for successful commercial manufacturing. With over 20 years of experience and 4 dedicated facilities across the UK, US, and China, we provide flexible and scalable GMP manufacturing solutions for small molecules, peptides, ADCs, and biologics, with the ability to handle batch sizes ranging from (as small as) grams up to multi metric-tons.
Commercial Capabilities
- Four late stage and commercial manufacturing facilities across UK, US and China
- Large scale advanced intermediates and regulatory starting materials (nonGMP and GMP)
- Large scale API GMP manufacturing up to 12,500 L (OEB4)
- Highly potent APIs (HPAPIs) up to 1,000 L (OEB5)
- Continuous Flow manufacturing up to 500 kg / day
- Hydrogenation – up to 7,000 L
- Controlled drugs manufacturing available in US and UK
Tech Transfer
By utilizing Pharmaron’s global capabilities, our clients can benefit from seamless and efficient tech transfer among our various sites to support transition all the way from early stage to scale up for late stage manufacturing. Our team of experts can also help you to quickly and efficiently transfer your existing products and processes from another CDMO, managing all aspects of the tech transfer.
Scale Up
Pharmaron’s facilities have an established history of GMP manufacturing for an array of APIs ranging from pilot scale all the way to commercial metric-tons. Our flexible approach to late stage manufacturing can deliver API batch sizes ranging from 10 L up to 12,500 L (OEB4), and high potency APIs up to 1,000 L (OEB5), enabling us to tailor product supply to your development program.
Process Validation
Pharmaron supports clients with documented evidence that the manufacturing process consistently delivers high quality products. This is attained through rigorous application of QbD principles to achieve robust Process Design, Process Qualification and Continued Process Verification over the lifecycle of a product and its processes.
Analytical Development and Validation
Pharmaron’s analytical development teams ensure that methods are fully developed and validated to ICH criteria. We offer phase appropriate analytical method development, qualification, validation, and tech transfer including:
- Impurity/degradant isolation, identification, characterization, and profiling studies
- Genotoxic impurity method development, validation, testing, and certification
- Trace metal method development, validation & testing
- Reference standard characterization, qualification, and management
- Control strategy alignment for in-process, drug substance specification setting
Life Cycle Management (LCM)
Pharmaron works closely with clients to optimize manufacturing processes, formulations, and delivery systems to extend a drug product’s commercial life and profitability. This includes post launch analysis and continuous improvement aimed at improving quality and efficiency, while reducing costs.
Global Regulatory and Environmental Record
Pharmaron manufactures at our GMP approved facilities in US, UK and China which (combined) are FDA, EMA, MHRA, NMPA, PMDA and Health Canada approved.
We integrate Environmental, Social, and Governance (ESG) principles into our business strategy, with key environmental commitments to achieve net-zero greenhouse gas emissions by 2050, promote green operations, and protect biodiversity.
Related Resources:
Explore Pharmaron’s Integrated CMC Platform
