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 – January 11, 2022 – Cambrex recently celebrated the 40th anniversary of its founding in 1981. Following forty years of growth and transformation into a leading global contract development and manufacturing organization (CDMO), Cambrex continues its commitment to leadership in pharmaceutical drug substance manufacturing with over $100 million of investments in progress across its global manufacturing network.
“As Cambrex celebrates our 40th anniversary, we are proud to be making significant investments in capacity and new capabilities across our network,” said Thomas Loewald, Cambrex CEO. He added, “Paired with our growing team of over 2,200 employees; these investments will enable us to serve our customers better as we partner with them in the development and manufacturing of novel, life-changing therapies.”
The largest of the expansions in Charles City, IA, is a $50 million project to support the large-scale development and manufacturing of small molecule drug substances. As the latest in a series of significant investments at the site, the expansion will increase the facility’s capacity by approximately 30 percent with reactors sized up to 16,000 liters, ideal for efficient production of large-volume commercial drug substances. The new capacity will come online during the first half of 2022.
In October 2021, a further $30 million investment was announced at Cambrex’s High Point, NC facility focused on clinical-stage drug substance and small-volume commercial manufacturing services. Now in progress, the expansion will approximately double the facility’s capacity by adding new chemistry laboratories, new clinical manufacturing suites, and a small-scale commercial manufacturing operation with reactors up to 2,000 liters. In addition to expanding Cambrex’s leadership in continuous flow chemistry, this investment will give Cambrex the ability to develop and manufacture highly potent APIs for its customers within a single facility. The High Point facility expansion will be completed during the first half of 2023.
In Europe, Cambrex is midway through a series of upgrades at its Karlskoga, Sweden facility totaling over $20 million, which will increase multi-purpose capacity by 25 percent and provide more flexibility in API manufacturing. Less than a year removed from installing a new 6,000-liter drug substance production line, the site is now executing a similar project to add additional cGMP manufacturing capacity by the end of 2022.
These investments, which span all scales of clinical and commercial drug substance manufacturing, will ensure Cambrex continues to be well-positioned to support its customers in the development and manufacturing of innovative new therapies that improve human health.
Cambrex is a leading global contract development and manufacturing organization (CDMO) that provides drug substance, drug product, and analytical services across the entire drug lifecycle. With over 40 years of experience and a growing team of over 2,200 experts servicing global clients from North America and European sites, Cambrex is a trusted partner in branded and generic markets for API and dosage form development and manufacturing.
Cambrex offers a range of specialized 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 specialty 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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