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.
Drug substance tech transfer is a complex activity carrying several technical, regulatory and quality risks. Whether you’re transferring your processes and know-how to our team or counting on us for seamless handoffs, a flexible, agile approach to tech transfer is vital.
At Cambrex, we offer a tried and trusted approach to technology transfer for scale-up or when transitioning to a different facility. Although we are able to draw upon our vast experience with drug substance tech transfer, we also recognize that every situation is potentially different and requires a distinct approach — or at least a tailored one. We are flexible, and our experts work diligently to evaluate the inherent complexity of your project to ensure our transfer scope and strategy are determined appropriately. We strive to increase your confidence in an efficient and successful transfer at all phases of your drug’s lifecycle.
The drug substance tech transfer skills and experience within our team are enabled by highly qualified experts and supplemented with ongoing training, support and continued professional development. The team is organized to support our unique manufacturing operation, which includes large-scale commercial cGMP production plants alongside our cGMP pilot plant and cGMP kilo laboratories. The result is a seamless, streamlined technology transfer process, with full and consistent support throughout the manufacturing journey, across all Cambrex sites.
Looking for a partner that balances passion with painstaking attention to detail. Speak to one of our experts how we approach drug substance tech transfers, and how it can help you succeed.
In our recent Organic Process Research & Development article, we discuss our collaboration with Alexion Pharmaceuticals on the technology transfer and process development of danicopan, an orally administered complement Factor D (FD) inhibitor, focusing on the challenges faced and strategies employed to meet client expectations within a compressed timeline.