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.
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.
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Peptide-based therapeutics are rapidly gaining clinical and commercial success, leading to the need for technologies to develop and scale these candidates. In this webinar, our team of experts discuss technologies and case studies surrounding liquid-phase peptide synthesis (LPPS), peptide crystallization, method development for peptide impurity analysis and more.
Cambrex offers innovative capabilities and technology to develop and manufacture synthetic molecules – peptides, oligonucleotides, synthetic DNA, block copolymers, polymeric linkers, functionalized dendrimers and modified carbohydrate polymers – for use in drug substances, medical devices and diagnostic agents.
In our recent article in European Pharmaceutical Review, Matthew Bio, Chief Scientific Officer at Cambrex, discusses how continuous manufacturing has become integral to the pharmaceutical industry, its uses in addressing technical challenges and complex chemistries and its expected growth in the coming years.