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.
Cambrex offers cutting-edge capabilities in peptide development and manufacturing, combining innovative technologies, diverse applications and specialized expertise to meet the growing demand for peptide-based therapeutics.
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. Cambrex specializes in seamless technology transfers and quick onboarding to keep your program on track.
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.
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.
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’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.
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 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 molecular complexity of peptides may have kept them out of development pipelines in the past, but innovations in synthesis and purification have fueled their recent momentum as alternatives to traditional small molecules to address unmet medical needs. Integrating crystallization into the development and manufacture of peptides can address key challenges, allowing for significant impurity rejection, improved processability, increased stability, full structural determination, and lower overall cost when compared to column chromatography methods for purification.
Watch Cambrex expert Hannah McLachlan as she explores these benefits in the crystallization of peptide fragments, as well as whole peptide compounds. She discusses how the team at Cambrex’s Edinburgh facility has recently developed a high throughput screening approach to initial crystallization screening for peptide fragments.
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In our collaboration with Sanofi, we developed a telescoped continuous flow manufacturing process for a key bromopyridine intermediate toward the investigational RIPK1 inhibitor oditrasertib (DNL788, SAR443820). By integrating continuous flow chemistry, process analytical technology and scalable crystallization development, we improved process efficiency, enhanced operational control and delivered the target intermediate in high purity through a streamlined three-step process.
In this interview, Matt Bio shares a forward‑looking perspective on the forces reshaping peptide manufacturing, exploring the industry’s transition from solid‑phase to liquid‑phase peptide synthesis, the growing role of peptide crystallization, and emerging enzymatic and synthetic approaches that expand what is possible in scalable manufacture.
Watch our recent webinar to see real examples of how automation and advanced optimization methodologies can be integrated into chemical process development workflows to accelerate scale-up, support reproducibility and improve efficiency.