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 15, 2018 – Cambrex Corporation (NYSE: CBM), the leading manufacturer of small molecule innovator and generic Active Pharmaceutical Ingredients (APIs), today announced that it has completed a pilot plant expansion at its High Point, NC facility with the installation and commissioning of a fourth reactor suite, increasing the site’s reactor capacity by around 30%.
The new 400 sq. ft. suite includes two 2,000 liter glass lined reactors and a 0.6 sq. m. Hastelloy C22 filter dryer, allowing the manufacture of batch sizes typically 10-100kg under cGMP conditions for clinical phase projects.
The High Point site has also completed and implemented an upgrade of its analytical chromatography data systems for QC and analytical R&D to new, Empower 3 software. Empower brings enhanced capability, integrity and compliance to the site’s analytical systems, in line with the increasingly stringent demands of the FDA and EMA among other agencies.
In a further announcement, Cambrex has reported that structural steelwork and foundations are now in place for a new $24 million facility at its Charles City, Iowa plant, for the manufacture of highly potent APIs (HPAPIs).
The 4,500 sq. ft. production area will operate to an occupational exposure limit (OEL) down to 0.1µg/m³ and will have a total reactor capacity of 2,200 gallons, consisting of a range of 200, 500 and 1,000 gallon glass and Hastelloy vessels to manufacture batches from 50 to 300kg.
The project will also see the reconfiguration of the existing small scale manufacturing area, providing a single high containment building to support early stage development and manufacturing, providing flexibility across a broad range of scale. The facility is expected to be operational in the first half of 2019.
“Both of these US investments will enhance Cambrex’s cGMP capabilities and offer our customers expanded technologies and services,” commented Shawn Cavanagh, COO of Cambrex. He added, “We will continue to strategically invest across our global network of sites at all scales, from clinical through to commercial, to address customer demands and market requirements.”
Cambrex recently announced that it had also completed the construction and validation of a new 11,000 sq. ft. analytical laboratory at its High Point facility, as well as completing the installation of multiple continuous flow reactor platforms.
Cambrex Corporation is an innovative life sciences company that provides products, services and technologies to accelerate the development and commercialization of small molecule therapeutics. The Company offers Active Pharmaceutical Ingredients (APIs), advanced intermediates and enhanced drug delivery products for branded and generic pharmaceuticals. Development and manufacturing capabilities include enzymatic biotransformations, high potency APIs, high energy chemical synthesis, controlled substances and continuous processing.
For more information, please visit www.cambrex.com
Thank you for subscribing up to our newsletter.