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 Snapdragon Chemistry, now part of Cambrex, our chemists specialize in creating custom solutions and technologies to take on your toughest process development and production challenges. This includes expertise in designing and building reactors that enable seamless technology transfer as a process scales up for commercial manufacturing.
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.
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 offers extensive development services tailored to meet your drug product needs in early development. From pre-formulation to Phase II, we ensure your products are developed with speed, flexibility, and quality in mind.
Whether you need rapid development, flexible manufacturing solutions, or high-quality production, Cambrex is your trusted partner for advancing your drug product from concept to the clinic.
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.
05.16.2017
Increases Site’s Reactor Capacity by 30%
East Rutherford, NJ – May 16, 2017 – Cambrex Corporation (NYSE: CBM), the leading manufacturer of small molecule innovator and generic Active Pharmaceutical Ingredients (APIs), today announced that it is to expand pilot plant capabilities at its High Point, NC facility with the installation of a fourth reactor suite. The $2.4M investment will increase the site’s reactor capacity by around 30%.
The new 400 sq. ft. suite, which is being constructed to meet growing business demand, will feature two 2000 liter reactors and a 0.6 sq. m. Hastelloy filter dryer, and is expected to be fully operational by early 2018.
“This expansion will facilitate the scheduling of cGMP campaigns for our customers and assist in meeting clinical deadlines,” commented Brian Swierenga, VP, Operations and Site Director for Cambrex High Point. He added, “In addition, with the new filter dryer we will be able to run small scale batches to demonstrate their feasibility for scale-up.”
In a second investment at the High Point site, Cambrex is to upgrade its analytical chromatography data systems for QC and analytical R & D to new, Empower 3 software. Empower will be introduced in Q3 and Q4 of 2017 and will bring 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.
Cambrex acquired the 35,000sq. ft. High Point site, formerly PharmaCore, Inc., in October 2016. At the North Carolina facility, Cambrex produces complex APIs and intermediates requiring multi-step synthetic processes in batch sizes from milligrams to 100kg to support clinical trials from Phase I 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 enhances Cambrex’s portfolio of small molecule API services and complements its large scale, multi-purpose manufacturing facilities in the US and Europe.
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 and controlled substances. For more information, please visit www.cambrex.com