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 – Cambrex Corporation (NYSE: CBM, “Cambrex”) will be exhibiting its products, and its capabilities in drug delivery and custom development and manufacturing services at InformexUSA 2010, February 16-19 in San Francisco, CA. In addition, Cambrex personnel will give two presentations at the Informex Technology Showcase on February 16.
The Informex event is highly regarded as the fine, specialty and custom chemistry showcase of innovative technology and quality products and services. Cambrex will be exhibiting its capabilities in Controlled Substances, High Potency/Cytotoxics, Highly Energetic Chemistries, Biocatalysis/Biotransformation and Chiral Synthesis in addition to its Polymeric Drug Delivery and Custom Development and Manufacturing Services.
The Informex Technology Showcase on February 16 provides exhibiting companies the opportunity to present their latest developments in technologies and services. In Cambrex’s first presentation, Dr. Mark Maier will present an innovative approach to determining occupational control limits for safely handling highly potent compounds. Cambrex’s approach utilizes in vitro testing that allows for a more accurate determination of exposure limits, thus providing better risk management while saving both time and money in the development of active pharmaceutical ingredients and intermediates.
In the second Technology Showcase, Dr. Jayne E. Muir will speak about Cambrex’s Continuous Flow Microwave Assisted Organic Synthesis (CF-MAOS) technology. The CF-MAOS dual technological breakthrough, which won the Silver Innovation award at CPhI 2009, allows both the scale-up of microwave-assisted chemistry and the handling of heterogeneous mixtures in a continuous-flow arrangement. Cambrex’s current technology, the CaMWave™ KiloLAB flow reactor, is capable of manufacturing over 20 kilograms of product per day. Further, the Company is developing larger reactors that have the potential to manufacture more than one hundred metric tons of product per year. This technology facilitates faster, cleaner, more reliable scale-up leading to improved productivity and lower manufacturing costs.
Cambrex will exhibit at booth 1628 in the Moscone Center during InformexUSA.