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.
Using reference standards or materials — substances used as the standard in an assay, identification, or purity test — allows you to assess the impact of any changes to the manufacturing process. One of the primary challenges in reference standard management is ensuring the authenticity and traceability of reference standards, requiring extensive documentation and testing. In addition to meeting regulatory requirements, which can be time-consuming and expensive, they must also be handled and stored appropriately to ensure stability and integrity.
Qualified reference standards play a critical role in providing validated benchmarks to satisfy regulatory requirements pertaining to purity of drug products. Additionally, they equip manufacturers with information they can apply to solve issues and assess the impact of changes to the manufacturing process. By investing in qualified reference standards early in development, Cambrex customers gain an edge in later problem-solving to act swiftly with well-informed decisions.
At Cambrex, we are prepared for these challenges. Our reference standard management program uses a laboratory information management system (LIMS) to create an efficient process for characterizing all reference standards relevant to each manufacturing process. A certificate of analysis (COA) is delivered to our clients with all our qualified reference standards, including detailed reports from the experiments to support regulatory filings. With analytical teams just a few doors down from our process chemists, our facilities are designed to minimize delays caused by the physical separation of different teams. You can rely on our experts’ decades of experience and deep knowledge of regulatory guidelines to deliver high-quality qualified reference standards.
In this case study, Cambrex’s integrated team of experts helped a client quickly identify and impurity, synthesize the reference standard, and develop a custom analytical method to characterize the impurity.
Looking for a partner that balances passion with painstaking attention to detail. Speak to one of our experts about how we can help you succeed with your reference standard management.