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.
Biological safety testing—including mycoplasma testing, biological reactivity assessments and cytotoxicity testing—forms a critical part of the pharmaceutical and medical device industries. Manufacturers integrate these specialized tests throughout development and manufacturing to proactively identify contamination, verify biocompatibility and ensure products meet stringent safety standards. This science-first approach supports regulatory compliance, protects patient health and maintains product quality, enabling manufacturers to deliver safe, effective therapies to market while minimizing risks and facilitating successful regulatory approvals.
Mycoplasma are extremely small bacteria lacking a cell wall, making them resistant to some antibiotics. They are notorious for contaminating cell substrates, compromising the integrity, safety and efficacy of biologic products by altering cellular metabolism, affecting experimental results and posing significant health risks to patients. Regulatory agencies require mycoplasma testing for biologics and some combination products to confirm that cell substrates are free from contamination and safe for use in manufacturing and clinical applications.
Cambrex delivers specialized mycoplasma testing service designed to safeguard your products by detecting mycoplasma contamination in cell cultures, biologics and raw materials used to generate those products. Our expertise ensures clients meet stringent regulatory requirements for biologics and combination products. We provide two methods required by USP and EP to detect mycoplasma contamination of test articles, cell cultures used to produce test articles or any other material in which contamination is suspected:
Our technical team collaborates closely with clients to select the optimal method for their application, ensuring robust results and regulatory approval.
Cambrex provides comprehensive biological reactivity and cytotoxicity testing services to evaluate the biocompatibility and safety of pharmaceutical and medical device materials. Aligned with ISO 10993-5 and USP <87> standards, our in vitro assays measure mammalian cell responses to material extracts, identifying potential adverse effects such as cell growth inhibition, lysis or death. These tests are critical for regulatory submissions, confirming that materials are safe for clinical use and helping manufacturers meet FDA, EMA, and other global compliance requirements.
Our technical experts guide clients through every step of the testing process, delivering thorough, reliable data that supports product development, regulatory approval and ongoing assurance of patient safety.
Our testing laboratories are FDA-registered and GMP-compliant, reflecting our commitment to excellence and regulatory compliance. This comprehensive framework ensures we deliver accurate, reliable and regulatory-ready results to support your product safety and successful regulatory submissions.
Cambrex’s team of experienced analysts and microbiologists deliver high-quality mycoplasma testing and biological reactivity testing services with quick and reliable turnaround times. Clients benefit from direct access to a dedicated account manager, who coordinates with our technical experts and operations teams to ensure proactive risk mitigation, project alignment with client goals, clear communication and prompt issue resolution.
We also offer courier services for sample pickup and delivery within a 150-mile radius of the Agawam, MA facility, ensuring sample integrity and convenience for clients.
Our scientists specialize in making connections. Start a conversation today and see how we can help with your biological safety testing needs.