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.
East Rutherford, NJ – May 5, 2021 – Cambrex today announced an expansion of cGMP analytical testing capabilities at its site in Longmont, Colorado. Existing space at the site has been repurposed with cutting edge technologies and doubles the footprint of the laboratory operations.
The world-class facility will gain approximately 1,800ft2 of laboratory space with a lean continuous improvement design deployed across the open module layout for efficiency. The expansion includes the addition of chromatographic equipment including uHPLC, HPLC, GC-FID/HS, and dissolution equipment (Apparatus 1 and 2 with online UV/Vis), as well as additional laboratory support equipment including 10 chemical fume hoods and working bench space.
“This expansion of our Longmont facility is an example of the investments Cambrex is making to expand on our wide range of CDMO services. The strategic expansions to the current good manufacturing practice (cGMP) testing area and addition of cutting-edge technologies enhances our stability programs and deepens the level of support we can deliver,” said Tracy Milburn, Director of Analytical Services, at Cambrex Longmont. “The implementation of a leaner structure across the facility optimizes the expansion for efficient use. And in conjunction with our sister sites for commercial scale drug substance in Charles City, Iowa and drug product commercial manufacturing in Mirabel, Québec and Whippany, New Jersey, we are able to support the customer throughout the entire drug development process.
The Longmont facility became part of the Cambrex global network of development and manufacturing facilities following the acquisition of Avista Pharma Solutions in 2019. The site supports customers with the development and manufacture of small molecule drug substance and drug product and provides full analytical development and cGMP testing support from discovery through to clinical scale. The site is fully integrated with direct technical transfer lines for commercial scale advancement to the Charles City, Mirabel, and Whippany sites.
In 2019, Cambrex was acquired by funds advised by Permira, a global investment firm, to continue to build upon Cambrex’s market leading position in API development and manufacturing and support the growth of its end-to-end integrated service offerings across the pharmaceutical value chain.
Cambrex is the leading small molecule company that provides drug substance, drug product, and analytical services across the entire drug lifecycle. The company provides customers with an end-to-end partnership for the research, development, and manufacture of small molecule therapeutics. With over 40 years’ experience and a growing team of over 2,100 experts servicing global clients from sites in North America and Europe, Cambrex is a trusted partner in branded and generic markets for API and dosage form development and manufacturing.
Cambrex offers a range of specialist drug substance technologies and capabilities, including biocatalysis, continuous flow, controlled substances, solid state science, material characterization, and highly potent APIs. In addition, Cambrex can support conventional dosage forms, including oral solids, semi-solids, and liquids, and has the expertise to manufacture specialist dosage forms such as modified-release, fixed-dose combination, pediatric, bi-layer tablets, stick packs, topicals, controlled substances, sterile and non-sterile ointments.
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