IND submission is a major milestone in the life of your drug. We can provide all supporting analytical data to help ensure a smooth application process.
We have the expertise, flexibility, and resources to provide a full range of pharmaceutical API custom development services at every stage of the lifecycle.
We can provide lab-, kilo- and pilot-scale manufacturing for preclinical studies and all phases of clinical trials, supplying milligram to kilogram quantities.
Cambrex brings more than 40 years of generic API manufacturing experience to its pharmaceutical partners. From our sites in Italy, Sweden, and the USA, we are a leading global supplier of generic APIs.
Cambrex offers cutting-edge capabilities in peptide development and manufacturing, combining innovative technologies, diverse applications and specialized expertise to meet the growing demand for peptide-based therapeutics.
Drug substance tech transfer sounds so simple on the surface, but it’s a complex activity carrying a number of technical, regulatory, and quality risks. Cambrex specializes in seamless technology transfers and quick onboarding to keep your program on track.
At Cambrex, we provide a range of technologies equipped to solve your API manufacturing challenges, and we are flexible enough to handle the most complex molecules.
At Snapdragon Chemistry, now part of Cambrex, our chemists specialize in creating custom solutions and technologies to take on your toughest process development and production challenges. This includes expertise in designing and building reactors that enable seamless technology transfer as a process scales up for commercial manufacturing.
You can rely on our extensive portfolio of analytical development solutions and testing services to rapidly advance your molecule for the greatest chance of success.
Cambrex’s experienced analysts are well-equipped to ensure microbial testing is of the highest quality for our customers and delivered with a quick and reliable turnaround.
We’re solid state chemistry experts who can deliver timely, phase-appropriate solutions to optimize the physical stability of your API, develop a more bioavailable formulation or overcome other challenges.
Cambrex and Q1 Scientific’s stability storage and sample management capabilities provide a variety of pharmaceutical storage conditions, with walk-in and reach-in chambers that meet all ICH Q1A requirements.
Cambrex offers extensive development services tailored to meet your drug product needs in early development. From pre-formulation to Phase II, we ensure your products are developed with speed, flexibility, and quality in mind.
Whether you need rapid development, flexible manufacturing solutions, or high-quality production, Cambrex is your trusted partner for advancing your drug product from concept to the clinic.
Cambrex is here to support you in early-phase development. Our development experts apply their ingenuity and skill to address your unique challenges.
Our teams of creative problem-solvers work closely with you to accelerate drug development timelines, optimize processes, and meet regulatory requirements.
We understand that the commercial phase of drug development can be challenging, especially when it comes to manufacturing at scale and meeting changing market demands.
Cambrex is a leading global supplier of more than 70 generic APIs, as well as intermediates and derivatives.
In a recent study coauthored by Sanofi and members of our Snapdragon Chemistry team, we describe the synthesis of the investigational RIPK1 inhibitor oditrasertib (DNL788, SAR443820) and demonstrate how continuous flow chemistry and process optimization can significantly improve pharmaceutical manufacturing efficiency. Our researchers developed a telescoped three-step synthetic route that integrates continuous processing with a single crystallization step to produce a high-purity bromopyridine intermediate in 68% overall yield and greater than 99.5% purity.
The work highlights several important process chemistry innovations, including the use of continuous flow manufacturing to streamline reaction sequencing, reduce operational complexity and improve process throughput compared to traditional batch manufacturing methods. By telescoping multiple synthetic steps into a single continuous operation, the process minimizes intermediate handling while supporting improved scalability and manufacturing consistency.
For pharmaceutical companies developing complex small molecule therapies, this approach demonstrates the practical value of modern continuous manufacturing strategies for RIPK1 inhibitor development and API process optimization. The study reinforces how advanced process chemistry, integrated crystallization techniques and continuous flow technologies can accelerate development timelines while enhancing product quality, operational efficiency and commercial manufacturing readiness.
To learn more about this program, please read the full article in Organic Process Research & Development.
View the full article (via ACS Publications)
Watch our recent webinar to see real examples of how automation and advanced optimization methodologies can be integrated into chemical process development workflows to accelerate scale-up, support reproducibility and improve efficiency.
Watch our recent webinar to learn about a new biocatalytic process developed at Cambrex Charles City in which we highlight the collaborative efforts of process chemists and engineers to develop an effective byproduct removal strategy.
Drawing on real-world case studies and deep industry expertise, our experts share actionable insights and proven strategies for navigating the critical trade-offs between balancing cost, time, and quality in drug development.