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.
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.
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.
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.
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 offers a comprehensive suite of testing services for complex biopharmaceuticals including standalone analytical R&D, method validation, release testing, ICH stability, and routine QC testing.
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’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.
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.
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 custom reactors that enable seamless technology transfer as a process scales up for commercial manufacturing.
After optimizing your process, our chemists and engineers apply their experience and problem-solving skills to build a self-contained custom reactor “skid” that allows the process to be performed anywhere. Our process engineering team develops a 3D CAD model of the skid before ordering and assembling custom components for the system, allowing for right-first-time designs.
Our customers use our skids for medicinal chemistry scale-up, process development and production in GMP environments (kilo lab and plant).
Our custom R&D reactor skids are designed to give our clients the power to use Snapdragon process development tools in their own labs, and these systems can be based on one of several platform technologies, such as hydrogenation, high temperature/pressure and photochemistry. They are customized to meet your needs and include Snapdragon control software to manage these complex systems easily.
Our GMP production skids use industry-standard automation technologies, including PLC-based control panels and a PC-based SCADA system. The control panels can be constructed to comply with a range of electrical safety requirements as needed, including UL and CE, and they can be rated for use in hazardous locations (explosion-proof/ATEX). The SCADA system provides a user interface and a data historian compliant with GMP electronic records requirements (21 CFR Part 11).
Operators can control equipment via a single interface and automate critical functions, such as start-up, shutdown, emergency stop and clean-in-place. Our automation systems can integrate into any plant-wide control system.
Snapdragon project managers provide regular status updates and maintain clear communication throughout the design and build process with you and the production facility.
Interested in learning more about our self-contained reactor skids? Start a conversation today with one of our reactor specialists.
In our recent article in European Pharmaceutical Review, Matthew Bio, Chief Scientific Officer at Cambrex, discusses how continuous manufacturing has become integral to the pharmaceutical industry, its uses in addressing technical challenges and complex chemistries and its expected growth in the coming years.
In our recent Organic Process Research & Development article, we discuss our collaboration with Pfizer, focusing on efforts to translate an early-stage batch route for the AXL-MER inhibitor oncology candidate PF-07265807 into a viable continuous flow process.
In this webinar, Dr. Matthew Bio, Chief Scientific Officer at Cambrex, showcases the application of continuous flow technology for scaling up modern synthetic approaches from pilot-scale to commercial production.