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.
When analyzing environmental monitoring data, the microbial identifications are just as, if not more significant, than the counts recovered. The constant recovery of microorganisms that are within the specification limits determined by the facility can still pose a threat to operations depending on the identification. The determination of the common organisms recovered in the classified areas should be trended and evaluated for why they are common and if they should be expected. The common organisms, once determined, should be incorporated in the growth promotion of media to have truly robust media fill and environmental monitoring programs. The organisms need to also be challenged during the validation of the disinfectant regiment that is routinely executed by the facility to determine if the reagents selected will be effective.
This will become more relevant in the coming months as two common disinfectant reagents, LpH II and Vepshene II, are being discontinued and new disinfectant reagents will need to be validated for use. The continuous environmental monitoring, microbial identification, and disinfectant qualifications ensures the selected disinfectant reagents continue to be effective against any organisms that are observed increasing in recovery frequency. Watch our webinar to learn more.
Ensure microbial control in the production environment through robust environmental monitoring, microbial identification and trending, and the use of proven cleaning protocols.
Cambrex is the industry leader in testing, validating, and monitoring controlled environments. Our experts will work with you to
define your program from frequency and duration of testing to specific methods and sampling plans.
Thank you for subscribing up to our newsletter.