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 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.
If you’re looking to outsource drug product development to a CDMO, you need a collaborative partner who will engage you deeply to understand the unique needs of your project.
From pre-formulation to commercial manufacturing and packaging, you can trust Cambrex to deliver your complex dosage forms with the perfect combination of technology, expertise, and collaboration.
At Cambrex, we offer a tried and trusted approach to technology transfer, for scale-up or when transitioning to a different facility.
We are equipped to take on projects at any size or scale, offering established pediatric formulation and development expertise and to-scale manufacturing capabilities.
Biopharma companies at all stages of development, rely on our expertise and broad capabilities to produce the clinical trial supply of drug products they need, when they need them.
We can support you, at any size or stage, with a range of primary and secondary packaging solutions.
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 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.
API crystallization processes are often difficult to reproduce and especially challenging to scale. If not done well, crystal size distributions can vary, requiring additional processing to ensure uniformity and can cause down-stream processing issues such as filterability and formulation challenges. To develop a scalable crystallization process, it’s critical to evaluate crystallization dynamics across the various phases of API development. This provides maximum control over impurities, polymorphic forms, particle size, and agglomeration.
Cambrex takes a phase-appropriate approach to crystallization process development. Our initial crystallization development efforts typically focus on early-stage API, often following screening studies, with a focus on delivering a fit-for-purpose crystallization process that will result in a target form with high yields, purity, appropriate particle properties and process efficiency. As the molecule advances and specifications and constraints become tighter, we shift our attention to optimization/robustness studies (Design of Experiment, or DoE) of existing crystallization processes, drying studies, and formulation development. After launch, our experts remain available to support crystallization operations, often in a troubleshooting capacity.
We apply the same principles to peptide crystallization. As a CDMO with expertise in bringing complex molecules to the market, we understand that peptides are particularly challenging when it comes to crystallization process development. Successful scale-up relies on a robust crystallization process to control the thermodynamic and kinetic factors that impact the solid form.
Everything begins with our crystallization scientists and engineers, who bring decades of experience to every project. At their disposal are the latest modelling software and process analytical tools to understand how bench-scale processes will perform on much larger scales in the plant. Using our expertise in statistical design and modelling, our team is able to gain an in-depth understanding of the critical process parameters of the crystallization, understanding the operating space and ensuring process robustness. Our development programs are tailored to final APIs or process intermediates.
Solid state properties of active pharmaceutical ingredients (API) are a critical attribute of any drug product and significantly impact the drug’s efficacy, safety, and stability. The selection, development and scaling-up of a solid-state form with desirable properties is therefore critical for the success of drug development programs.
Cambrex’s understanding of crystal formation and thermodynamics allows us to develop custom, scalable crystallization processes for your peptides.
In this case study, Cambrex applied rigorous characterization standards and expert knowledge of critical water activity to isolate a previously undiscovered and uncharacterized polymorph for our client.
We love challenges, which is why we love crystallization process development. Contact us to discuss your project.