Innovative solutions for advanced pharmaceutical manufacturing
Continuous manufacturing
Thermo Fisher Scientific is at the forefront of adopting advanced manufacturing technologies to enhance efficiency in small molecule development and commercial production, benefiting both us and our customers. As the number of new clinical development projects increases, we leverage these cutting-edge technologies to meet the growing demand for novel drug candidates. Our approach relies on the utilization of modern tools for analytics, statistical design, control, and process intensification, all applied through the continuous manufacturing of drug substances and drug products.
78%
We are a trusted partner, involved with 78% of the top performing drug products1
50 years
Almost 50 years of contract pharmaceutical manufacturing experience
26 of the top 100
We manufactured 26 of the top 100 best-selling OSD drugs in 2022
~70
~70 manufacturing /primary clinical packaging rooms as of 2023
Pharmaceutical manufacturing solutions and capabilities
Our innovative drug substance development and manufacturing solutions include:
- Continuous manufacturing (CM) for both chemical synthesis and purification operations, at scales ranging from single kilograms to multiple tons.
- Design of experiments (DoE) for an in-depth understanding of our manufacturing processes.
- Model predictive control (MPC) to support scale up and minimize off-spec material.
- Multi-attribute method (MAM) to assess protein sequence and product quality, such as the biotherapeutic's efficacy, safety, stability, and process robustness, and tailor development based on characterization data collected and client needs.
These capabilities allow us to rapidly develop reliable manufacturing processes that consistently deliver high-quality products, even when complex molecules or operations, extreme temperatures, or hazardous materials are involved.
Our innovative drug product continuous manufacturing offers development and manufacturing solutions from Phase II through commercial, including:
- Integrated Continuous Direct Compression (CDC) tableting lines with Process Analytical Technology (PAT) for real-time monitoring and control. These units allow for flexible batch sizes that accommodate both clinical and commercial scales using the same process and manufacturing train.
- Enabled for Real-Time Release (RTR) with PAT, including in-line Near Infrared (NIR) Spectroscopy, at-line disintegration, friability, microwave-based moisture measurement, and traditional IPCs (H, W, T).
- Process development and clinical supply from Phase II onward: Includes a commercial control strategy, PAT, and RTR.
Our experienced team can assist customers with adopting continuous solid dose manufacturing, providing full-service support from clinical stage development through to commercial manufacturing.
Helpful resources
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