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 – September 25, 2018 – Cambrex Corporation (NYSE: CBM), the leading manufacturer of small molecule innovator and generic Active Pharmaceutical Ingredients (APIs), and finished dosage forms today announced that it is to establish a center of excellence for API clinical supply and process development at its site in High Point, North Carolina. Cambrex will acquire its currently leased 35,000 sq. ft. facility, as well as an adjacent 45,000 sq. ft. building which will be fitted out with kilo-scale and pilot-scale vessels, continuous reaction production, and chemistry, engineering and analytical development laboratories.
The purchase of the current and adjacent facility is in response to growing customer requirements for clinical supply manufacturing, analytical and chemical development. The center will also focus on the development of new technologies, innovative chemistry and engineering solutions as well as expertise in technology transfer to commercial scale.
“The purchase of the High Point site gives us greater control over the future of our North American business to allow us to invest in making this a central hub and leader in clinical supply, process and technology development in the US,” commented Steven Klosk, Cambrex’s President and CEO. He added, “Since we acquired the former PharmaCore business, now Cambrex High Point, in October 2016, we have invested over $5 million at the site and this is set to continue with both the strategic building acquisition and subsequent fit-out. By the time of its completion we will have nearly tripled the workforce at the site to approximately 150 staff.”
At its High Point facility, Cambrex produces complex APIs and intermediates requiring multi-step synthetic processes in batch sizes from milligrams to 100 kg in support of clinical trials from Phase I through to Phase III. The site is licensed with the US Drug Enforcement Administration (DEA) to manufacture Schedule II to Schedule V controlled substances. The acquisition enhanced Cambrex’s portfolio of small molecule API services and complements its large scale, multi-purpose manufacturing facilities in the US and Europe.
In April 2017, Cambrex announced that it had completed the construction and validation of a new $3.2 million, 11,000 sq.ft. analytical laboratory at the High Point facility to support growing customer demand for analytical development and validation services in support of clinical stage cGMP products.
In addition, in May 2018, Cambrex announced completion of a new clinical manufacturing suite with 2000 liter reactors and a 0.6 sq. meter hastelloy filter dryer to manage increasing demand for clinical APIs.
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), finished dose forms, 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
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