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.
If you’re looking to outsource drug product development to a CDMO, you need a collaborative partner who will engage you deeply to understand the unique needs of your project.
From pre-formulation to commercial manufacturing and packaging, you can trust Cambrex to deliver your complex dosage forms with the perfect combination of technology, expertise, and collaboration.
We are equipped to take on projects at any size or scale, offering established pediatric formulation and development expertise and to-scale manufacturing capabilities.
Biopharma companies at all stages of development, rely on our expertise and broad capabilities to produce the clinical trial supply of drug products they need, when they need them.
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 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.
After optimizing your process, our chemists and engineers apply their experience and problem-solving skills to build a self-contained 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.
Customers use our skids for medicinal chemistry scale-up, process development and production in GMP environments (kilo lab and plant).
Our R&D 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 this article, Cambrex’s Chief Scientific Officer and President of Snapdragon Chemistry, Matthew Bio, sat down with CPHI for an interview to talk about the project that won Snapdragon the 2023 CPHI Pharma Award for API Development.
Cambrex offers continuous flow process development services to provide our customers with improved control, increased safety, lower costs, and more.
During this webinar, we showcase how Snapdragon’s CM lab development platform accurately models production-scale systems enabling right-first-time scale-up.