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.
Container Closure Integrity Testing (CCIT) stands as a core pillar of quality assurance in the pharmaceutical and medical device industries. CCIT evaluates the ability of packaging systems—such as vials, syringes and infusion bags—to maintain a sterile barrier and prevent contaminants from entering throughout the product’s shelf life. Regulatory agencies require robust CCIT data for product approval and ongoing quality assurance, making it essential for sterile products like injectables and implantable devices. By confirming packaging integrity, CCIT safeguards patient safety, supports product stability and ensures compliance with USP and international standards, ultimately protecting product efficacy and reducing the risk of recalls or adverse events.
Cambrex provides comprehensive CCIT services to help clients meet the highest standards for sterility and regulatory compliance. Our laboratories utilize advanced methods and accredited processes to provide reliable, regulatory-compliant results, including:
Cambrex uses the dye ingress method to assess the physical integrity of container closure systems. Containers are exposed to a dye solution under vacuum or pressure; any breach allows dye to penetrate, providing a clear visual indication of compromised integrity. This straightforward test is ideal for routine quality control and validation, efficiently detecting leaks or defects in packaging systems.
Our microbial ingress testing challenges container closures with a microbial suspension under controlled conditions. This stringent method determines whether microorganisms can penetrate the closure, directly demonstrating the system’s ability to maintain sterility throughout the product lifecycle. It is especially critical for products labeled as sterile, providing robust data to support regulatory submissions and market approval.
We can perform vacuum decay testing to deterministically assess the integrity of container closure systems without compromising product sterility. Using the Sepha Multi‑Q instrument, sealed containers such as vials, syringes, and cartridges undergo a controlled vacuum while the system monitors for pressure changes that indicate the presence of leaks. This non‑destructive technique provides sensitive, quantitative data to detect micro‑leaks, supporting robust sterility assurance for injectable and other high‑risk pharmaceutical products.
Cambrex also offers pressure decay testing, a deterministic, non‑destructive CCIT approach that evaluates container closure integrity by applying positive pressure and monitoring for pressure loss over time. Using the same Sepha Multi‑Q instrument, this method is well suited for rigid and semi‑rigid packaging systems where controlled pressurization enables precise leak detection. Pressure decay testing delivers reproducible, quantitative results that support quality control, method validation, and regulatory submissions.
Cambrex’s CCIT services apply to a wide range of pharmaceutical and medical device packaging. Our proven track record, technical proficiency and collaborative teams ensure clients receive science-based solutions that support product safety, regulatory compliance and successful market entry.
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 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 testing needs.