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.
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. Cambrex specializes in seamless technology transfers and quick onboarding to keep your program on track.
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.
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’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.
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 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.
Determining the shortest, most economical path from investigational new drug (IND) to commercial launch is no easy feat.
Our experienced team can help you answer the myriad of questions and challenges that arise as you move your custom small molecule API development projects forward. We have the expertise, flexibility and resources to provide a full range of pharmaceutical API custom development services at every stage of the lifecycle, from IND support and pre-clinical to Phase III studies and technology transfer for commercial supply.
We offer a range of custom small molecule API development capabilities, including route selection, process development and optimization and analytical development and validation. We offer all of these services as a true partner whose success is intimately linked to yours.
Also in this section
Effective process development connects process chemistry, impurity control, analytical development, process safety and solid-state science to create robust, scalable manufacturing processes. We build process understanding with manufacturing realities in mind, helping pharmaceutical and biotech teams improve reproducibility, manage technical risk and transition efficiently from early development through scale-up, GMP manufacturing and technology transfer.
Reliable analytical data is essential for making informed decisions throughout API development. Working alongside process chemistry and other CMC disciplines, we develop robust methods and measurement strategies to evaluate reaction performance, impurity behavior and material attributes, reducing uncertainty and maintaining analytical continuity through scale-up, technology transfer and GMP manufacturing.
Identifying chemical and thermal hazards early helps prevent safety issues from emerging during scale-up and manufacturing. Using process hazard analysis, calorimetry and other safety studies, we establish operating limits and mitigation strategies that account for changing equipment and scale, reducing risk while supporting safer, more reliable API development and manufacturing.
Selecting the right solid form can influence an API’s stability, manufacturability and downstream performance. We evaluate polymorphs, salts, solvates and other solid forms through targeted screening and solid-state characterization, helping pharmaceutical and biotech teams select a suitable form, reduce development risk and establish a stronger foundation for formulation and crystallization.
Crystallization process development translates solid-form understanding into reproducible, scalable manufacturing processes. Cambrex integrates crystallization science, particle and impurity control, process monitoring and equipment-aware scale-up to deliver the intended form, purity and material attributes consistently.
Maximizing the value of an R&D portfolio requires determining which candidates are ready to move forward from discovery to preclinical testing and development. Our chemists provide holistic chemistry services to ensure the readiness of necessary reactions.
We love challenges, and we would like to learn more about yours. Contact us to discuss your API drug development needs.
What can derail an early development program, and which risks can be solved before they become major delays? In this webinar, Cambrex experts Cy Credille and TJ Harper discuss common challenges in early pharmaceutical development, including scale effects, impurity control, particle morphology, crystallization behavior, analytical issues, and phase-appropriate decision-making.
Peptide crystallization offers a powerful approach to improving purification, stability and process efficiency in peptide manufacturing. In this webinar, Cambrex’s Hannah McLachlan explores the advantages of crystallizing peptide fragments and whole peptide compounds, including the use of high throughput screening to accelerate development and guide process optimization through real-world case studies.