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.
Detecting elemental impurities — typically trace, heavy metal impurities — has challenged the pharmaceutical industry for decades. Regulatory changes in 2018 to harmonize requirements outlined in USP <232> and <233> with ICH Q3D guidelines further complicated control strategies. Determining how to evaluate the risks associated with aqueous solutions, chemical excipients, and container-closure systems can tax an analytical testing operation without deep expertise in elemental impurities testing.
When you partner with Cambrex, your analytical testing challenges become our priority. Our scientists have a proven track record of elemental impurities testing. With extensive experience in heavy metals testing and advanced analytical and sample preparation techniques, we are highly qualified to help you develop a risk-assessment strategy for elemental impurities. From documentation, analytical screening and development/validation of a material-specific method, we work with you to achieve compliance. Our ICP-MS instrumentation housed in our material characterization labs is available to analyze challenging sample matrices, such as plastics, lubricants and complex APIs.
In general, we have two approaches to generating elemental impurity data to support risk assessment activities:
Validation activities, including a method developed by Cambrex to analyze all listed ICH Q3D elements using the parenteral limits, would be performed on each novel material to support the elemental impurity risk assessment as part of the filing.
Methods may be developed utilizing specific elements and limits when requested. Validation studies will be evaluated per USP <233> using either a Quantitative Method or Limits Method.
We love challenges, and we would like to learn more about yours. Contact us to discuss your elemental impurity needs.
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