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.
Injectable medicines have several advantages, including rapid absorption and onset of action, compared to oral drugs, but they also present unique safety challenges for patients. Injectables are capable of bypassing natural skin and digestive tract barriers designed for toxins, and because of this ease of administration, all injectable medicines must face additional regulatory requirements. Specifically, injectables requiring multiple doses are subject to the most stringent regulatory control, and for these cases, regulations mandate that in-use testing be performed on multiple-dose containers.
In-use studies are intended to demonstrate that multi-dose injectable drug products retain acceptable quality specifications upon opening or puncturing of the container and throughout the drug’s administration into a human patient. If applicable, an assay of the API and preservative should be performed throughout the duration of the in-use study to monitor the levels at each testing interval. Additionally, Antimicrobial Effectiveness Testing (AET) per USP <51>, or Sterility Testing per USP <71> as an alternative, should be performed at the end of the study.
At Cambrex, we will work with you to design and perform all in-use testing and microbiological safety testing for your final marketed drug product and associated container/closure system. Our experts can design and perform all of the testing needed for in-use studies by leveraging our analytical expertise and demonstrated excellence in microbiological safety testing. We are here to help you clear the regulatory hurdles and advance your injectable product to the market.
We love challenges, and we would like to learn more about yours. Contact us to discuss how we can help with your in-use testing needs.