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, N.J., June 04, 2019 (GLOBE NEWSWIRE) — Cambrex Corporation (NYSE: CBM), the leading small molecule company providing drug substance, drug product and analytical services across the entire drug lifecycle, today announced that it has completed a new 600 m2 facility at its site in Karlskoga, Sweden, which incorporates new laboratories for process and analytical development.
The new, three-story building will incorporate process technology, QC and analytical development laboratories. The process technology laboratories will expand capacity providing an area where R&D and production teams can work together on scale up demonstration and technology transfer, including new capabilities in the scaling up of potent molecules requiring containment. The facility will employ computer modeling to optimize reactor set ups and plant conditions to improve technology transfer and the performance of existing processes.
The laboratory also includes high pressure reaction vessels and crystallization equipment to optimize drug substance manufacturing, as well as expanding the temperature range at which reactions can be carried out, with vessels to handle conditions from cryogenic to nearly 200 degrees Celsius. The new QC and analytical development laboratories increase the capacity and capabilities for handling in-process and raw material analysis.
To support the site’s recent growth, which has included the expansion of large scale manufacturing capacity, a new $6 million, 3,000 m2 logistics center has also been completed and opened. This includes a fully cGMP-compliant warehouse with integral temperature monitoring and control, and has the capacity for 4,500 pallets.
“This expansion and investments we have made at Karlskoga are part of an ongoing strategic program to ensure it has the flexibility, capacity and capabilities to meet the evolving needs of the market and industry,” commented Bjarne Sandberg, Managing Director, Cambrex Karlskoga. “The new technical laboratory will act as a hub for the company’s engineers, operators and chemists to ensure smooth scale up and handover of processes from development sites across our global network.”
Cambrex’s site in Karlskoga employs over 400 people and features a wide range of flexible manufacturing facilities including 4 cGMP pilot plants and 7 full scale commercial production units.
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 2,000 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. In addition, Cambrex can 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.
For more information, please visit www.cambrex.com