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.
At Snapdragon Chemistry, we understand how complex the drug development journey can be – from submitting an investigational new drug (IND) application to scaling up. We’re here to help you navigate that journey. Based on your needs, our talented chemists and engineers can provide holistic chemistry services to rapidly develop and optimize your reactions, while considering the importance of seamless technology transfer either within your own facilities or within the Cambrex network.
Depending upon your stage of development, we provide comprehensive consulting services regarding:
While agnostic to the process development approach utilized, we have unique expertise in completing multiple synthetic steps in one continuous flow process across a broad set of reactions and conditions. By employing integrated multi-step processes, customers tap into some of the greatest benefits of this novel chemical technology.
Our leadership has spearheaded many of the major developments in the flow chemistry field, and we employ chemists who have had hands-on experience in utilizing flow technology to transform synthetic routes (e.g., reducing the number of synthetic steps, improving conversion and decreasing residence time) and substantially increase their efficiency. Our broad experience in translating reactions into flow enables us to take a unique look at your portfolio to identify these opportunities and help you achieve a step-change in productivity.
Continuous flow chemistry is typically used as a last resort to address challenges in conventional batch methodology. As a result, there are often missed opportunities to apply continuous flow chemistry to enhance product development and gain the greatest advantages of flow technology. Our consultants offer a detailed analysis of your portfolios, reviewing reactions and processes across a set of molecules and proactively identifying key opportunities to use innovative chemistry to improve productivity. No matter your challenges, we will work closely with your team to determine a customized plan that best suits your needs.
Our scientists never back down from complex chemistry challenges. Start a conversation today with one of our optimization specialists.
In our recent article in European Pharmaceutical Review, Matthew Bio, Chief Scientific Officer at Cambrex, discusses how continuous manufacturing has become integral to the pharmaceutical industry, its uses in addressing technical challenges and complex chemistries and its expected growth in the coming years.
In our recent Organic Process Research & Development article, we discuss our collaboration with Pfizer, focusing on efforts to translate an early-stage batch route for the AXL-MER inhibitor oncology candidate PF-07265807 into a viable continuous flow process.
In this webinar, Dr. Matthew Bio, Chief Scientific Officer at Cambrex, showcases the application of continuous flow technology for scaling up modern synthetic approaches from pilot-scale to commercial production.