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 – March 14, 2019 – Cambrex Corporation (NYSE: CBM), the leading small molecule company providing drug substance, drug product and analytical services across the entire drug lifecycle, today announced that it has completed the expansion of a new 150m2 research and development laboratory at its site in Paullo, Milan, Italy. In addition, Cambrex has installed a new 12,000 liter reactor into one of its cGMP manufacturing facilities at the site.
The R&D laboratory includes both chemistry and analytical development capabilities, with the installation of semi-automated glass lined reactors, as well as analytical instruments including multiple high and ultra-performance liquid chromatography, and gas chromatography systems, which have now been qualified and validated. To complement investments at other Cambrex sites, the new laboratory has also installed a flow chemistry system to allow for continuous manufacturing development.
The installation of the 12,000 liter reactor, along with the replacement of centrifuges with new, more efficient equipment in one of the site’s seven production departments, was part of a $3 million investment to upgrade and improve the efficiency of the plant which manufactures intermediates and generic APIs under GMP conditions.
“This investment is part of our ongoing strategy to ensure that the site can adapt to the growing and evolving needs of the generic API industry,” commented Aldo Magnini, Managing Director, Cambrex Milan. “Investing in key technologies such as continuous flow will allow us to look at new opportunities for the site to expand our portfolio of generic products, in a similar manner to the investment in highly potent API containment that we undertook in 2017, which allowed us to increase the number of new highly-potent oncology products in development.”
Cambrex manufactures over 70 generic APIs which are produced to cGMP standards at the Milan site, where the seven production departments are supported by a pilot plant, kilo-scale plant and development and analytical laboratories.
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 35 years’ experience and a growing team of over 2,000 experts servicing global clients from sites in North America and Europe, Cambrex is your trusted partner in branded and generic markets for API and dosage form development and manufacturing.
Cambrex offers a range of specialist drug substance technologies including biocatalysis, continuous flow, controlled substances, solid state science, material characterization and highly potent APIs. In addition, Cambrex can support conventional dosage forms including solids, semi-solids and liquids and also has the capability to manufacture specialist dosage forms such as solid dose, fixed dose, pediatric, bi-layer, stick packs, topicals, controlled substances, sterile and non-sterile dose forms.