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 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.
Pharmaceutical development has become increasingly complex, even for traditional small molecules. To support complex molecules, we’ve added core competencies in highly specialized process development and manufacturing technology to help our clients overcome the most challenging chemistry.
At Cambrex, we provide a range of technologies, solutions and expertise to help solve your API development and manufacturing challenges. We are flexible enough to handle the most complex molecules, and we have a proven record of high quality and regulatory compliance — and of advancing programs through each phase of the development lifecycle.
Our range of specialty API capabilities include:
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At our High Potency Development Center (HPDC), Cambrex can develop a range of high-potency APIs. Our toxicology and chemistry experts will work closely with your team to address your unique HPAPI challenges and to safely and effectively develop and manufacture your compound.
Cambrex offers a full range of process development services to help our customers take advantage of the benefits of continuous flow. Our experts can help you develop scalable processes from proof-of-concept to cGMP manufacturing.
Customers targeting rare diseases can now trust Cambrex for all of their small-volume commercial needs. Recent expansions will add three new commercial manufacturing suites, enabling us to support API manufacture on a 2000 L scale.
The experts at Cambrex have been helping customers with their controlled substance API challenges since 2005. We are licensed for importation of Schedule I to IV controlled substances, and we have Drug Master Files (DMF) for more than 20 controlled substance APIs.
Our biocatalysis development services, led by our team of experts in Wiesbaden, Germany, allow us to provide our customers with highly pure regio-, chemo- and enantioselective compounds, when compared to traditional chemical synthesis.
Cambrex takes a phase-appropriate approach to crystallization process development. Our scientists and engineers use state-of-the-art analytical tools to understand the critical process parameters of the crystallization and to develop a robust, scalable process for commercial manufacturing.
Cambrex works closely with your development team to implement the appropriate monitoring strategy for your program needs. We have the experts and the equipment to provide advanced monitoring, including ReactIR™ spectroscopy, Raman spectroscopy, focused beam reflectance measurement (FBRM) and more.
Solid state properties of active pharmaceutical ingredients (API) are a critical attribute of any drug product and significantly impact the drug’s efficacy, safety, and stability. The selection, development and scaling-up of a solid-state form with desirable properties is therefore critical for the success of drug development programs.
For drug developers commercializing orphan drugs, the search to find small-scale commercial partners presents a unique challenge – one that we are prepared to solve for you.
Cambrex’s understanding of crystal formation and thermodynamics allows us to develop custom, scalable crystallization processes for your peptides.
We love challenges, and we would like to learn more about yours. Contact us to discuss your unique needs.
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