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.
Cambrex offers cutting-edge capabilities in peptide development and manufacturing, combining innovative technologies, diverse applications and specialized expertise to meet the growing demand for peptide-based therapeutics.
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. Cambrex specializes in seamless technology transfers and quick onboarding to keep your program on track.
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.
At Snapdragon Chemistry, now part of Cambrex, our chemists specialize in creating custom solutions and technologies to take on your toughest process development and production challenges. This includes expertise in designing and building reactors that enable seamless technology transfer as a process scales up for commercial manufacturing.
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’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.
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 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 offers extensive development services tailored to meet your drug product needs in early development. From pre-formulation to Phase II, we ensure your products are developed with speed, flexibility, and quality in mind.
Whether you need rapid development, flexible manufacturing solutions, or high-quality production, Cambrex is your trusted partner for advancing your drug product from concept to the clinic.
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.
Potential for microbiological contamination is a top priority for any pharmaceutical or medical device company, which must demonstrate its manufacturing environments are sufficiently controlled to formulate, manufacture, test, package, store and safely ship products that are intended for human use. If you’re looking for a partner to support your microbiology testing program, a key consideration is finding a lab that not only provides comprehensive quality data but also timely and effective solutions to any challenges that you face.
At Cambrex, we champion a science-first approach to microbiology testing, combining decades of technical expertise, advanced instrumentation and a collaborative culture. Our FDA-registered, cGMP laboratories deliver high-quality, reliable microbiology testing solutions that help clients meet the rigorous quality standards required for regulatory approvals in the pharmaceutical and medical device industries. Our experienced scientists provide comprehensive data and timely, effective solutions to support your product development and manufacturing needs, ensuring patient safety and regulatory compliance.
Learn more about our full breadth of pharmaceutical and medical device microbiology capabilities and services below.
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Our AET and antibiotic services help pharmaceutical and medical device manufacturers demonstrate preservative efficacy, support product development and ensure regulatory compliance.
By using validated culture-based methodologies and rapid bioburden testing options, Cambrex ensures accurate, reproducible results to protect your products and patients by ensuring that every component, raw material or finished item is free from microbial contamination.
Our Container Closure Integrity Testing (CCIT) services, apply to a wide range of pharmaceutical and medical device packaging, including vials, syringes and infusion bags.
We deliver industry-leading services, leveraging deep expertise and advanced microbiology labs to validate cleaning protocols against site-specific microbial isolates.
Cambrex offers robust endotoxin testing (bacterial and kinetic) and validation services to meet the diverse needs of pharmaceutical and medical device manufacturers globally.
As an industry leader in filter testing, we offer a suite of services including bacteria filter retention testing, filter integrity testing/bubble point testing and forward flow testing.
Cambrex’s laboratories leverage advanced incubation protocols and technical expertise to validate processes, ensure product safety and support regulatory compliance at every stage of development.
Our MET methods include pour plate, spread plate and membrane filtration techniques for counting colony-forming units (CFUs) of bacteria, yeasts and molds – each designed for different scenarios based on your needs.
We offer clients’ robust microbial identification services, both phenotypic and genotypic, to help them effectively control contamination, validate cleaning and disinfectant protocols and support robust environmental monitoring programs.
Biological safety testing forms a critical part of development, helping clients proactively identify contamination, verify biocompatibility and ensure products meet strict safety standards.
We offer a full suite of sterility testing and validation services, each method designed to detect microbial contamination with precision and reliability, making sure your products are safe and compliant.
We provide robust testing services to ensure the water used in your pharmaceutical and medical device production is free from impurities that could compromise your product’s safety or efficacy.
Our scientists specialize in making connections. Start a conversation today and see what it’s like to work with a collaborative CDMO.