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.
Despite the promise of increased safety, yield and efficacy, analytical method development and validation can pose significant challenges during development and production of simple and complex APIs. Developing suitable and robust analytical methods requires a thorough understanding of the underlying process chemistry to account for potential process impurities that may exist, but also for potential degradants.
At Cambrex, our experts are well-suited to tackle your method development challenges. Our experienced teams are highly knowledgeable of the regulatory requirements and possess deep scientific and technical expertise to deliver solutions for your development needs. As your partner, we offer a vast range of analytical capabilities with state-of-the-art facilities housing advanced instrumentation to ensure reliable and consistent analytical results. More importantly, our team has a proven reputation for taking on tough challenges and delivering phase-appropriate methods that support programs from early pre-clinical through to commercial. When you partner with Cambrex, our teams will collaborate with you on your project and provide open communication and transparency throughout to achieve the milestones of your program.
Our extensive experience with analytical method development and validation includes the following example method types:
Cambrex had a short, 7-week time frame to complete assay optimization and conduct pre-validation studies within the confines of USP<621>. See how we did.
Cambrex offers fast and detailed method development services that will see clients’ molecules through early phase development and beyond.
Our comprehensive method optimization service takes early-stage development methods with poor stability, excessive run times, or legacy column chemistries and enhances them.
We love challenges, and we would like to learn more about yours. Contact us to discuss your method development and validation needs.
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