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.
Reliable manufacturing of drug substances for clinical trials is critical for any pharmaceutical company, but it can be particularly challenging for small and emerging organizations if they lack the in-house expertise, capacity or scale needed as the demand becomes greater in later phases.
At Cambrex, our flexible clinical manufacturing services can supply the clinical trial drug substance materials you need to meet your changing demands. We work closely with your team to understand the clinical development plan and to provide a nimble and flexible clinical manufacturing solution. Our highly trained operations team collaborates closely with our process chemists and process engineers, who accompany the process into the pilot manufacturing facility to ensure smooth transfer to later-phase clinical batches through commercial launch.
We operate multiple manufacturing facilities to meet the varying demands of clinical trials, with the capabilities to produce active pharmaceutical ingredients (APIs) for Phase I through large Phase III trials and beyond:
Support for non-GMP synthesis of APIs and intermediates up to 10 kg.
Durham, NC, USA
Support for Phase I through Phase II with capacity from 1 L to 200 L.
Waltham, MA, USA (Snapdragon Chemistry)
Support for Phase I through Phase II with capacity from 1 L to 100 L.
Longmont, CO, USA
Support for Phase I through Phase II with capacity from 5 L up to 200 L.
High Point, NC, USA
Support for Phase I through commercial launch with capacity from 5 L to 2,000 L.
Charles City, IA, USA
Support for late Phase II through commercial launch with capacity from 400 L to 16,000 L.
Support for late Phase II through commercial launch with capacity from 50 L to 12,000 L.
Paullo (Milan), Italy
Support for late Phase II through commercial launch with capacity from from 37 L to 14,000 L.
Our experts and facilities are equipped to handle your unique clinical trial demands. By choosing Cambrex as your clinical manufacturing partner for an upcoming trial, you can be confident that you will receive high-quality API and exceptional support at every step.
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.
Partner with a CDMO who can deliver right-sized solutions for your small-volume program at each stage and grow with you from early development through commercialization.
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.
Looking for a partner that balances passion with painstaking attention to detail? Speak to one of our experts about how we can help you run a successful clinical trial.
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