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.
At Cambrex, we offer a tried and trusted approach to technology transfer, for scale-up or when transitioning to a different facility.
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.
We can support you, at any size or stage, with a range of primary and secondary packaging solutions.
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.
With the acquisition of Snapdragon Chemistry, Cambrex has strengthened our reputation as a provider of solutions for the most complex chemistry problems. Snapdragon scientists and engineers, working in state-of-the-art laboratories and leveraging advanced software and equipment, painstakingly pursue scalable synthetic processes for clients. We take pride in being able to “crack the code” on chemical development in a way that others can’t, and we don’t rest until your molecules are thoroughly characterized and your processes are repeatable, reliable and ready for production.
While agnostic to our client’s process development approach, we have unique expertise in completing multiple synthetic steps in one continuous flow process across a broad set of reactions and conditions. We leverage our advanced capabilities in autonomous process development and reactor platforms to deliver robust and scalable chemistry solutions for your toughest problems. Innovators that can harness flow technology while applying artificial intelligence and machine learning early in the development process will have a decisive, lasting advantage over competitors as the technology enables important productivity, efficiency and speed enhancements.
Cambrex, enhanced by Snapdragon’s world-class consulting capability, can help you optimize API drug development processes. We can suggest process improvement and scale-up concepts that leverage cutting-edge technology to solve the most complex chemistry challenges.
We offer extensive drug substance manufacturing capabilities, which Snapdragon supports with state-of-the-art process development and the ability to implement GMP manufacturing in its facilities or within Cambrex’s vast network of global sites.
Our focus on scientific innovation promotes an entrepreneurial culture, leading to the development of proprietary technologies that we offer to clients, enabling you to handle complex chemistries in-house.
Snapdragon chemists can establish your process with the goal of transferring to a self-contained reactor, which can be used in your own lab. Our process engineering team develops a 3D CAD model of the reactor skid before ordering and assembling custom components for the system.
Maximizing the value of an R&D portfolio requires determining which candidates are ready to move forward from discovery to preclinical testing and development. Snapdragon chemists provide holistic chemistry services to ensure the readiness of necessary reactions.
Snapdragon Chemistry can help you develop and manufacture complex synthetic molecules — like block copolymers, polymeric linkers and functionalized dendrimers — using advanced technologies and data-rich experimentation.
Our scientists specialize in complex chemistry. Start a conversation today and see what it’s like to work with an industry-defining CDMO.
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.
In part two, we explore relevant examples of continuous flow in the manufacture of APIs and intermediates focusing on practical applications and highlighting processing advantages.
Our streamlined IND data collection and submission strategy, based on our decades of experience, helps accelerate your filing process without sacrificing quality.
We offer comprehensive analytical testing services to provide the data you need for critical early-phase drug development decisions. At our state-of-the-art facilities, Cambrex experts ensure regulatory compliance and the highest standards for safety and efficacy.
Our development experts specialize in using creative problem-solving to handle early-phase challenges while maintaining validation rigor to avoid late-stage process changes. This helps you advance more rapidly to late-stage manufacturing.
With decades of experience and broad capabilities, our flexible manufacturing and packaging solutions can support changing demands to meet your late-phase clinical trial needs.
Our facilities in Whippany, NJ, USA, and Mirabel, Québec, Canada, are equipped to produce the late-stage clinical trial supply of drug products you need, when you need them. We offer a wide variety of sterile and non-sterile packaging solutions for a range of dosage forms.
By offering a comprehensive suite of analytical testing services, we can support your late-phase development and ensure your clinical trial materials meet the highest standards for safety and quality.
At Cambrex, our experts specialize in API manufacturing and scale-up from preclinical to commercial phases. We offer extensive manufacturing capabilities, streamlined technology transfer, and consistent support across all sites.
Our facilities are designed to be flexible so we can meet your commercial manufacturing needs, ranging from small-scale for orphan drugs to large-scale commercial production.
Although every technology transfer process is different, our experts apply their skills and knowledge to make the transition to commercial manufacturing as smooth as possible.
Cambrex is a leading global supplier of generic APIs with sites in Italy, Sweden, and the US. We collaborate with generic drug firms before patent expiration and offer comprehensive services and manufacturing capabilities.
Our global manufacturing facilities reliably supply high-quality advanced pharmaceutical intermediates and raw starting materials. We maintain a large catalog of APIs and have a proven track record for meeting cGMP standards.