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.
Successful IND submissions require an intense coordinated effort to meet strict requirements while balancing speed to file. The processes involved in API development must continuously adapt to changes in regulations along with the unique traits of each API to achieve successful manufacturing strategies and IND approval. Even during beginning stages of API synthesis, the most successful design incorporates adjustments based on thorough analysis of each reaction step.
The starting point is often derived through medicinal chemistry, and it may not be readily scalable, safe or meet regulatory standards for purity. Designing the best synthesis route for later success with IND submission must account for all impurities while aiming to reduce steps that are impractical for scale-up in terms of timing and cost.
In this case study, we follow our client’s compound through a full cycle of IND development, from modifications to the synthetic route to formulation development and API manufacturing. Learn how our team meet challenges with expert analysis and rapid problem solving to ensure your submission has the highest yield with a phase appropriate purity.
Thank you for your interest in our content.
Partner with a CDMO who can deliver right-sized solutions for your small-volume program at each stage and grow with you from early development through commercialization.
For drug developers commercializing orphan drugs, the search to find small-scale commercial partners presents a unique challenge – one that we are prepared to solve for you.
Cambrex’s understanding of crystal formation and thermodynamics allows us to develop custom, scalable crystallization processes for your peptides.
Thank you for subscribing up to our newsletter.