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.
The application of continuous processing can afford certain advantages during development and scale-up, such as enhanced risk mitigation of hazardous compounds and reducing both manufacturing cycle time and solvent waste through telescoping steps and avoiding intermediate isolations. While telescoping is not unique to flow, the operating windows enabled by the process intensification only possible in flow are significant, and they often possess the additional benefit of accessing chemistries not feasible in a traditional batch process.
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. The route to the key intermediate of interest features two SNAr reactions, the latter utilizing aqueous hydrazine to enable an intramolecular cascade reaction, followed by a Boc deprotection. We assessed and demonstrated the suitability of the process for telescoping steps in flow by finding a solvent/base system that maintained the solubility of all species and led to efficacious reactions. We performed additional studies to reduce the concentration of aqueous hydrazine solution used as a feed in the continuous process to 5 wt % hydrazine, adding to the various safety advantages not amenable to a traditional batch process. Additionally, we utilized an automated D-optimal design of experiment study for the aqueous hydrazine step to increase our process understanding and screen effects during this early stage of development.
To learn more about the results of this collaboration, please read the full article in Organic Process Research & Development.
View the full article (via ACS Publications)
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 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.
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.