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 you partner with Cambrex, you can feel confident about your project progressing between stages and facilities with ease. We take a proactive approach to drug product tech transfer and apply our expertise, agility, and broad capabilities to advance your product seamlessly through every stage of development and manufacturing.
When partnering with a client on a pharmaceutical tech transfer project, Cambrex takes the position that the initial development and manufacturing approach may not have sufficiently challenged all the key parameters, including the raw materials, the product attributes, and the process. To avoid any knowledge gaps, Cambrex may perform all the design and development work needed to produce the customer’s product and demonstrate qualitative and quantitative equivalence between the new and existing products. For customers who need to change their manufacturing supply chain for an existing product, Cambrex’s experienced staff can manage all aspects of the technology transfer process.
At Cambrex, your product will have a dedicated project manager to ensure a smooth drug product tech transfer. Our project managers are technical experts, providing full and consistent support to each product’s progress. If an internal site transfer is necessary, our specialists will frequently travel to the receiving site to ensure a seamless transition. This makes transfers faster and more efficient. The tech transfer skills and experience within our team are supplemented with ongoing training, support, and continued professional development.
Our customers benefit from the cost and time savings realized with a comprehensive approach that combines the technology, equipment, and scientific and engineering expertise needed to manufacture a high-quality product.
We love challenges, and we would like to learn more about yours. Contact us to discuss your project and how we can assist with your drug product tech transfer.