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.
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.
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.
Peptides present increased complexity for crystallization due to their large size, structural flexibility, and diverse functional groups, which lead to a much narrower crystallization operating range compared to small molecules. Compounded by a high risk of gelling, fibrillation and aggregation, these challenges often result in low-purity outcomes and elevated residual solvent contents. Even when solids are recovered, they are frequently isolated as amorphous forms, which pose significant challenges in handling, production and downstream formulation steps. These complexities necessitate innovative approaches to ensure the successful crystallization of peptides while maintaining their structural integrity and therapeutic efficacy.
At Cambrex, we recognize the critical role of crystallization in overcoming the inherent challenges of peptide manufacturing. In parallel with our investment in custom peptide synthesis technologies, we have developed cutting-edge peptide and protein crystallization capabilities to address these complexities.
Our proprietary screening platform is specifically designed to discover and optimize crystalline forms of peptides and proteins. This platform leverages advanced techniques to identify conditions that promote crystallization, even for highly complex or aggregation-prone peptides. By integrating crystallization into the manufacturing process, we offer clients a range of benefits that address key challenges in peptide production:
Our approach to peptide crystallization is rooted in science-first innovation and a commitment to solving the most complex challenges in development and manufacturing. It’s not just a manufacturing step — it is a transformative process that enhances the quality, stability and efficiency of your peptide therapeutics.
Download our information sheet to explore how Cambrex’s expertise can elevate your drug development program.
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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 and more – for use in drug substances, medical devices and diagnostic agents.
Solid state properties of active pharmaceutical ingredients (API) are a critical attribute of any drug product and significantly impact the drug’s efficacy, safety, and stability. The selection, development and scaling-up of a solid-state form with desirable properties is therefore critical for the success of drug development programs.
Looking for a development partner that balances passion with painstaking attention to detail? Speak to one of our peptide experts about how we can help you succeed.