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.
How do you optimise stability study design for regulatory approval? Watch our guest speaker Kate Coleman, VP Regulatory Affairs, Quality and Compliance (Principal Consultant) at Arriello discuss the secrets of regulatory success.
In this engaging webinar, Kate explores the critical aspects of stability study design and execution across the entire product lifecycle. Whether you’re an analytical expert, a quality specialist, or a regulatory professional, this session is tailored for you.
Here’s what Kate covers:
Kate Coleman – Arriello Kate Coleman is the VP of Regulatory Affairs, Quality and Compliance at Arriello and has over 20 years of experience in the Pharmaceutical Industry across several platforms including Biologics, Sterile Fill Finish, Vaccines, and Oral Dose. Kate is a Qualified Person, Principal Consultant, Lead Auditor and an SME in several areas including Quality Control and Stability. Kate’s wealth of knowledge illuminates the intricacies of stability study design and its impact on regulatory success.
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Join our expert panel for an engaging discussion on the multifaceted responsibilities critical for maintaining product stability throughout the biopharmaceutical supply chain. Topics include how process changes impact product stability, thorough stability testing strategies, and anticipating and mitigating risks through comprehensive stability testing.
Cambrex and Q1 Scientific’s stability storage and sample management capabilities serve the Pharmaceutical, Medical Device and Life Sciences industries, with locations across North America and Europe. We offer long-term storage and analysis of reference standards to ensure a consistent, high-quality supply for your needs.
Join us to hear Prof. Jonathan Douxfils, CEO and Co-Founder of QUALIblood, as he explains the latest regulations in biobanking and their impact on clinical studies, what changes researchers may need to implement in their projects, and the potential challenges in complying with these new regulations.