Process Development Services
Broad experience and access to the latest technological capabilities are essential for today’s increasingly complex API development and manufacturing. By partnering with Thermo Fisher Scientific, you’ll work directly with scientists with deep chemistry knowledge and many years of experience in successfully supporting early and later phase clinical development programs. Our experts offer you cutting edge technology from start to finish in multi-step chemical synthesis and from traditional to complex manufacturing.
Our core competencies include:
- Process optimization and development
- Rapid scale up from laboratory to support early phase activities
- API production under cGMP conditions for Phase I, II & III clinical trials
- Broad range of chemistries to handle both low and highly potent compounds
- Tech transfer and scale up of existing processes
- Process validation
- Full regulatory support with CMC documentation
- Expertise with structurally complex and difficult-to-manufacture APIs
- Facilities to handle highly potent compounds and controlled substances
- Comprehensive analytical services
Scale up will include risk assessment and proven acceptable range (PAR) studies, as well as validation of analytical methods and the manufacturing process. If needed, our QA/regulatory compliance team can provide data and support for the CMC portion of your submission. API for use in clinical trials is produced at state-of-the-art manufacturing facilities in Europe and North America. All our facilities comply with cGMP regulations and are regularly inspected by national regulatory agencies.
A team of experts will surround your discovery with a full range of technologies and analytical services to run the project with the highest degree of flexibility, and deliver on time with exceptional yields and superior quality. In late-stage trials and beyond, your drug substance will be manufactured at a cGMP commercial production facility, where a team of experts works continuously to optimize processes, increase outputs and reduce timelines.
Our clinical and commercial batch manufacturing capabilities include:
- Dedicated early and late phase facilities in both Europe and North America
- Scale from grams to kilos to tonnes
- A comprehensive array of development technologies, services and solutions
- Extensive sourcing network for starting materials and advanced intermediates
- Potential to combine with drug product services for a streamlined, end-to-end supply chain
- Quality system compliant to most major Regulatory Bodies
- Full regulatory support with CMC documentation
- Flexible commercial manufacturing solutions
Expertise in Innovative Chemical Processes
We have the ability to undertake a broad range of chemistries at all scales required to produce APIs for Pre-Clinical, Phase I, II and III studies. Our manufacturing capability is supported by comprehensive analytical services and regulatory compliance experience. We have also invested in a number of innovative technologies to enable you to rapidly achieve your goals at each phase of development while laying a sound foundation for your future success, including capabilities in:
- “Continuous flow” processes in microreactors: Only Thermo Fisher Scientific can deliver today the efficiency, flexibility and scalability of the lab of tomorrow with reliability at commercial scale.
- Advanced catalysis: Bring feasibility to more of your most challenging discoveries and most complex processes with access to interdisciplinary route scouting, proprietary biocatalytic processes and scale up timelines reduced from years to months.
- Polymer APIs: We can combine proprietary process technologies, deep polymer science knowledge and large-scale cGMP production expertise to deliver these unique products
- Cryogenic manufacturing: Access low-temperature capabilities down to -85 °C in 200 L – 2,000 L reactors.
- High-pressure manufacturing: Take advantage of 1,000 psi high-pressure processing, including hydrogenation, at 200 L and 2,000 L scales.
- Highly potent compounds: Put your trust in our global network of facilities featuring the latest high-containment infrastructure.
- Controlled substances: Gain access to facilities that are fully licensed by the United States Drug Enforcement Administration (DEA).
End-to-end Solutions for the Small Molecule Challenges Ahead
We have the science, methods, breadth of services and technology to solve the most complex small molecule challenges. These include the proven ability to make it Right First Time, at scales from grams to kilos to tonnes, and a superior regulatory track record. We can deliver a faster, seamless path from early API development to scale up and commercialization with global reach and scale. These are just a few of the reasons to choose Thermo Fisher Scientific for your API production. However, the most compelling reason is our people. The scientists, engineers and experts who surround your discovery with the sharpest minds in the business—so that you can maximize the true potential of your molecule and deliver it to the patients who need it most.