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.
Working with Cambrex and Snapdragon Chemistry, our clients benefit from a proactive and phase-appropriate approach to API process development and validation, as well as access to advanced technology and industry-leading expertise in autonomous process development.
Early drug development studies are traditionally designed to support fit-for-purpose manufacture of early clinical materials. Our scientists can suggest process improvements early to:
If looking to establish a continuous process, our laboratory services can support the implementation to prepare scaled quantities of your target product. We can also work with your in-house team to design and build process-scale reactors to ensure seamless technology transfer.
Some of the reactors we use to develop autonomous processes for our clients include:
As molecules progress, we help to create more cost-effective, robust and safe processes to manufacture your active ingredient for pilot and commercial production. Cambrex excels at turning early routes into commercially viable manufacturing routes during the drug development cycle.
We are structured to oversee custom small-molecule process development from early clinical phase to commercial production, and we offer a flexible manufacturing landscape, with small-, mid- and large-scale facilities designed to support customized solutions and seamless transfer of technologies.
Our development teams specialize in finding creative solutions to early-phase challenges while remaining focused on the rigors of validation. As a result, we can help you to avoid late-stage process changes, which could impact your speed to market. The result is more efficient preparation of your APIs and intermediates and greater confidence in your project’s success.
Our scientists specialize in making connections. Start a conversation today and see what it’s like to work with a collaborative CDMO.