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 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.
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.
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 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.
The increasing focus on high-potency active pharmaceutical ingredients (HPAPIs) in pharmaceutical development pipelines, driven by the demand for oncology drugs, has led to a growing requirement for the capability to safely handle and contain these hazardous ingredients. Many CDMOs claim to be able to handle HPAPI manufacturing, but relatively few can legitimately manage the hazards associated with the complex production challenges.
At Cambrex, we have been reliably developing and manufacturing high-potency APIs and compounds for years, including immunosuppressants, cytostatics/protein kinase inhibitors, ultra-potent cytotoxic drug substance, drug linkers, PEG and cyclodextrin polymeric conjugations and toxins for antibody drug conjugates (ADCs). At our High Potency Development Center (HPDC) in Charles City — a controlled-access facility with barrier isolation, airlocks and cascading air differentials equipped to handle low ng/m3 occupational exposure limits (OELs) — we can develop a range of HPAPIs, including compounds classified as ultrapotent. Our HPDC houses cross-functional high-potency teams, including experts in chemistry and toxicology, who will work closely with your development team to ensure that we can safely and effectively develop and manufacture your compound.
Our cytotoxic, cytostatic and controlled substances capabilities include:
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If you have any questions, please feel free to get in touch with one of Cambrex’s experts.
In our recent article in Specialty Chemicals Magazine, Cambrex’s Daniele Vigo and Matthew Bio share a case study on the development of the highly potent generic API, olaparib, from our new process development lab in Milan, Italy.
Cambrex can develop and manufacture a broad spectrum of highly potent APIs (HPAPIs) utilizing highly regimented safety protocols with controlled access and barrier isolation.
Cambrex’s decades of high potency API experience and collaborative approach led to a successful partnership.
We love challenges, and we would like to learn more about yours. Contact us to discuss your highly potent API program.