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.
When you need a trusted partner to help advance your molecule through development and testing, you can count on Cambrex to help you find the most efficient path to a high-quality solution. Our analytical services encompass best-in-class chromatographic, spectroscopic and mass spectrometric solutions, enabling us to deliver rapid method development for small molecules, large molecules and live biologic materials.
When you need a partner to overcome challenging test methods — or challenging molecules — you can rely on the Cambrex team. Our customers appreciate our partnership, our expertise, our specialized services and our flexibility to solve complex problems as they navigate regulatory requirements. We offer a broad range of analytical testing services that extend across every phase of drug development.
Many biopharmaceutical products have complex and unique testing challenges. You can confidently turn to us for critical insights into product performance with our full range of biopharmaceutical testing services. Whether you are a biotech startup or an established biopharma company, our experts will work closely with you to understand your needs, identify solutions and provide testing services to advance your program.
We offer extensive solid state screening, as a standalone service or as part of a comprehensive drug development program, to help your team understand and characterize the physical properties of your active pharmaceutical ingredient (API). Our specialists provide testing for a range of physical and chemical properties and deliver timely, phase-appropriate solutions.
Our extensive microbiology testing services, delivered at our FDA-registered and GMP-compliant labs, address customer needs for API and drug product safety at every phase of development. Our experienced analysts provide personalized attention, ensuring that your project receives high-quality and timely results to assess microbiological safety.
Cambrex offers state-of-the-art, environmentally-controlled and monitored facilities to meet all ICH Q1A guidelines. We have dedicated stability rooms and chambers validated for long- and short-term shelf-life studies, making it possible to evaluate the quality of your API and drug product over time when exposed to different temperature and humidity conditions.
Our streamlined IND data collection and submission strategy, based on our decades of experience, helps accelerate your filing process without sacrificing quality.
We offer comprehensive analytical testing services to provide the data you need for critical early-phase drug development decisions. At our state-of-the-art facilities, Cambrex experts ensure regulatory compliance and the highest standards for safety and efficacy.
Our development experts specialize in using creative problem-solving to handle early-phase challenges while maintaining validation rigor to avoid late-stage process changes. This helps you advance more rapidly to late-stage manufacturing.
With decades of experience and broad capabilities, our flexible manufacturing and packaging solutions can support changing demands to meet your late-phase clinical trial needs.
Our facilities in Whippany, NJ, USA, and Mirabel, Québec, Canada, are equipped to produce the late-stage clinical trial supply of drug products you need, when you need them. We offer a wide variety of sterile and non-sterile packaging solutions for a range of dosage forms.
By offering a comprehensive suite of analytical testing services, we can support your late-phase development and ensure your clinical trial materials meet the highest standards for safety and quality.
At Cambrex, our experts specialize in API manufacturing and scale-up from preclinical to commercial phases. We offer extensive manufacturing capabilities, streamlined technology transfer, and consistent support across all sites.
Our facilities are designed to be flexible so we can meet your commercial manufacturing needs, ranging from small-scale for orphan drugs to large-scale commercial production.
Custom Manufacturing
Although every technology transfer process is different, our experts apply their skills and knowledge to make the transition to commercial manufacturing as smooth as possible.
Cambrex is a leading global supplier of generic APIs with sites in Italy, Sweden, and the US. We collaborate with generic drug firms before patent expiration and offer comprehensive services and manufacturing capabilities.
Our global manufacturing facilities reliably supply high-quality advanced pharmaceutical intermediates and raw starting materials. We maintain a large catalog of APIs and have a proven track record for meeting cGMP standards.
Despite the evolving landscape, the success rate for drug candidates during early development continues to be low. However, when you understand the pitfalls that can impede early development, the associated risks can be effectively managed, ultimately driving your program and your organization toward long-term commercial success.
Securing end-to-end biopharmaceutical testing services has become increasingly challenging for biopharma companies at all stages of development. Learn why it is often advantageous for them to leverage a single laboratory for analytical services.
Our analytical development and testing experts are here to help you rapidly advance your biologic for the greatest chance of success.
We love challenges, and we would like to learn more about yours. Contact us to discuss your project.
Our newsletter
Thank you for subscribing up to our newsletter.