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 formation of Csp3–Csp2 bonds is a powerful means of synthesizing high-value chemicals. Nickel catalysis has offered numerous avenues to Csp3–Csp2 bond assembly via cross coupling of Csp3 electrophiles, but most methods make use of organometallic compounds as transmetalating agents, which are reminiscent of classic Kumada, Negishi, and Suzuki couplings. (2) The needs of using these highly sensitive, less functional group compatible organometallic reagents necessitated the development of additional modes of nickel-catalyzed Csp3–Csp2 bond formation using native functional groups as latent nucleophiles.
In our article published in Organic Letters, we discuss how we, in collaboration with a team of scientists at the Massachusetts Institute of Technology, developed a process of electrochemically driven, nickel-catalyzed reductive coupling of N-hydroxyphthalimide esters with aryl halides. We explain how the reaction proceeds under mild conditions in a divided electrochemical cell and employs a tertiary amine as the reductant. The resulting decarboxylative Csp3–Csp2 bond-forming transformation exhibits excellent substrate generality and functional group compatibility. Through an operationally simple continuous-flow version of this transformation using a commercial electrochemical flow reactor, we present a robust and scalable synthesis of the value-added coupling process.
Read the entire article, “Ni-Catalyzed Electrochemical Decarboxylative C–C Couplings in Batch and Continuous Flow,” to learn more about how we utilized a continuous process to prepare reagent 1 on >100 g scale.
View the full article (via ACS Publications)
Cambrex offers innovative capabilities and technology to develop and manufacture synthetic molecules – peptides, oligonucleotides, synthetic DNA, block copolymers, polymeric linkers, functionalized dendrimers and modified carbohydrate polymers – for use in drug substances, medical devices and diagnostic agents.
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.