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.
Detecting elemental impurities — typically trace, heavy metal impurities — has challenged the pharmaceutical industry for decades. Regulatory changes in 2018 to harmonize requirements outlined in USP <232> and <233> with ICH Q3D guidelines further complicated control strategies. Determining how to evaluate the risks associated with aqueous solutions, chemical excipients, and container-closure systems can tax an analytical testing operation without deep expertise in elemental impurities testing.
When you partner with Cambrex, your analytical testing challenges become our priority. Our scientists have a proven track record of elemental impurities testing. With extensive experience in heavy metals testing and advanced analytical and sample preparation techniques, we are highly qualified to help you develop a risk-assessment strategy for elemental impurities. From documentation, analytical screening and development/validation of a material-specific method, we work with you to achieve compliance. Our ICP-MS instrumentation housed in our material characterization labs is available to analyze challenging sample matrices, such as plastics, lubricants and complex APIs.
We love challenges, and we would like to learn more about yours. Contact us to discuss your elemental impurity needs.
In general, we have two approaches to generating elemental impurity data to support risk assessment activities:
Validation activities, including a method developed by Cambrex to analyze all listed ICH Q3D elements using the parenteral limits, would be performed on each novel material to support the elemental impurity risk assessment as part of the filing.
Methods may be developed utilizing specific elements and limits when requested. Validation studies will be evaluated per USP <233> using either a Quantitative Method or Limits Method.
In our latest whitepaper, we dive deeper into the strategic benefits of outsourcing stability storage, provide you with a comprehensive guide on how to select the right partner for your needs, and highlight case studies that showcase real-world examples of pharmaceutical companies that have successfully outsourced stability storage and reaped the benefits.
Performing stability storage in-house can entail significant costs and risks for pharmaceutical and medical device companies, including capital and operational expenditures, compliance risks, and opportunity costs due to capacity constraints. In our recent infographic, we highlight the various costs and risks associated with in-house stability storage.
Outsourcing stability storage to the right partner can help pharmaceutical and medical device companies by saving costs, freeing resources, and ensuring regulatory compliance. Our infographic highlights the advantages of outsourcing over in-house storage, such as faster product development, risk mitigation, flexibility, and access to expert insights and customized solutions.