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Development Services - Drug Substance - Large Molecule Biologics Development
Fast, Flexible Cell Line Development Services
Comprehensive upstream process development capabilities, including cell line development, and a commitment to innovation, quality and service, make us the ideal partner for the process development of your mammalian cell culture projects. Our expertise spans multiple commercial cell lines, including CHO (Chinese Hamster Ovary), as well as cGMP cell banking.
Development Services - Drug Substance - Small Molecule API Development
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.
Route Scouting Services
Establishing the best synthetic route for your molecule is the basis for a reliable supply throughout the product’s life cycle. During route scouting, the following considerations are important when selecting the optimal pathway: Safety, Efficiency, purity and costs, Ease of optimization and scale up, IP review, Security of supply of raw materials, Impact on waste and the environment.
Analytical Development & Validation Services
Repeatable, High Quality and Robust Process Design; We offer an in-depth understanding of reaction profiles and the quality and physical form of starting materials, intermediates and the final product are critical components of API (active pharmaceutical ingredient) development. To support route scouting and process development activities and accelerate your clinical programs, we provide a comprehensive range of analytical services.
Small Molecule API Development Services
At Thermo Fisher Scientific, our people pride themselves on solving your API development challenges. Our objective is to help speed your molecule through early phase trials and prepare you for commercial success, faster. Whether you start working with us in early phase or late, we draw on years of experience and deep expertise to achieve industry-leading performance. Whether you need small quantities of API for initial development work or many kilograms for a late phase trial, you can reduce the risk and raise the bar on quality of small molecule development with a partner whose reputation is built on both quality and excellence in chemistry.