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.
The development of synthetic molecules for use in drug substances, medical devices and diagnostic agents is becoming increasingly complex. The number of steps required to synthesize certain molecules has increased considerably, and so has the need for enabling technologies to overcome bioavailability challenges. These complex molecules require a step change in advanced process, analytical and manufacturing technologies and expertise.
Snapdragon Chemistry, now a part of Cambrex, can help you develop and cGMP manufacture complex synthetics. Our chemists use data-rich experimentation and advanced process analytical technology (PAT) tools, enabled by proprietary LabOS™ software, to efficiently determine the design space and optimal conditions for manufacturing complex synthetics. We leverage technologies such as solid-phase synthesis, tangential flow filtration, nanofiltration, ion exchange chromatography and wiped film evaporation to enable robust and reproducible cGMP manufacture of complex synthetics, such as:
If you’d like to learn more about our complex synthetics capabilities, please contact us – we enjoy solving challenges, and we’d love to hear more about yours.
Our scientists specialize in making connections. Start a conversation today and see what it’s like to work with a collaborative CDMO.
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.