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 – October 12, 2020 – Cambrex announced today the completion of an expansion of its solid form screening and crystallization process development facility in Edinburgh, Scotland. This major expansion project has seen the facility’s total footprint doubled to 15,000 square feet, with existing laboratory space having been refurbished, and an additional 3,500 square feet of laboratory space added.
“We have seen an increase in demand for services, and specifically for larger-scale crystallization projects, so this expansion increases our efficiency and ability to respond to these requests,” commented Tom Loewald, Chief Executive Officer of Cambrex. He added, “The work we carry out at the Edinburgh site is one part of Cambrex’s integrated drug substance offering, and the investment increases our flexibility to work on projects at all stages of drug development.”
Cambrex’s Edinburgh site is a world-class facility, providing solid form development services for drug substance and drug product. These include solid state investigations such as salt, co-crystal, and polymorph screening, in addition to crystallization process development and GMP analytical services. The expert scientists at the site work on projects both as a standalone service to a range of pharmaceutical innovators, as well as liaising with other Cambrex sites to offer an integrated process development service.
The expansion has added an additional 13 fume cupboards to the laboratory, including three that are “walk-in”, which will allow the Edinburgh team to increase capacity and provide its clients with larger process crystallization development, up to 20-liter scale. The site currently has 50 employees, and the expansion will add additional laboratory space to enable the recruitment of up to 40 more scientists, with the potential for further growth in the future.
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 2,100 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. Cambrex can also 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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