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.
Rigorous, effective analytical testing is key in the drug development and manufacturing lifecycle. Because this testing is used to verify control of drug chemistry, it can help identify barriers that prevent movement to the next phase in the development process. That’s why it’s critical to have efficient, accurate and high-quality analytical support for your testing requirements.
At Cambrex, 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. In our more than 211,000 sq ft of combined laboratory space, we have a vast range of capabilities in analytical instrumentation and advanced detection, including high-throughput chromatographic column screening, enabling us to generate high-impact development datasets with efficiency for our clients.
Our experienced analytical staff reviews all processes to ensure the procedures, results and documentation are of the best quality to support regulatory filings. Whether you need full pipeline support or individualized services, our laboratories and experienced team are fully equipped to meet your analytical testing requirements and ensure that your products meet the highest safety and efficacy standards.
Learn more about our full breadth of analytical testing capabilities and services below.
Also in this section
Our scientists specialize in making connections. Start a conversation today and see what it’s like to work with a collaborative CDMO.
Ensure the purity of your raw materials, API and final product by selecting the most accurate and precise assay procedures to confirm drug composition.
Our extensive equipment and storage infrastructure support full cGMP release and routine QC testing, including method onboarding, stability storage and testing of raw materials, APIs and drug products.
Characterize your materials beyond chromatographic or infrared techniques. We offer thermal analysis, particle size determination and X-Ray powder diffraction (XRPD).
Make use of our significant expertise with ICH Q3D and USP <232> / <233> for control of elemental impurities to achieve quality and compliance.
We’re well-equipped to analyze your materials and ensure all specifications can be met, including those needed for regulatory compliance.
Our approach pairs our analytical and synthetic chemists together with access to advanced instrumentation, including HPLC, NMR and high-resolution MS to characterize, isolate and identify impurities rapidly.
We offer services to conduct FDA-required risk assessments and subsequent actions to evaluate the presence of nitrosamines, which can arise from select manufacturing steps, and to eliminate them in the chemical process.
E&L testing has emerged as a priority to assess the risk of impurities arising from packaging. Our experts can help you analyze any material in direct contact with your API, including glass, plastic and foil pouches.
Qualified reference standards are critical in providing validated benchmarks to satisfy regulatory requirements. Let us connect the value of investing in reference standards to your final product quality.
Our services include in-use studies to characterize the safety and efficacy of any API that will be delivered using a multi-dose container.
Coordinated through our Agawam, MA site, our environmental monitoring and cleanroom services ensure the quality of your manufacturing environment.
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.
Ensure microbial control in the production environment through robust environmental monitoring, microbial identification and trending, and the use of proven cleaning protocols.
Cambrex offers fast and detailed method development services that will see clients’ molecules through early phase development and beyond.
Thank you for subscribing up to our newsletter.