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.
In the June 24th edition, Pharma’s Almanac asked Matt Bio, Cambrex’s Chief Scientific Officer, how life science technology providers can support our industry in transitioning to more digitally connected operations, and he responded with the following:
“Supporting the pharmaceutical industry’s digital aspirations will require that technology providers already be fully digital in data acquisition and management. For CDMOs serving the industry, supporting the digital aspirations of customers requires a fully digital solution from lab to manufacturing via integrated data management platforms. In development, CDMOs should be able to provide data-rich experimentation in a fully digital environment. The adoption of low-cost IoT technologies in the laboratory connected to a common data-acquisition platform can provide real-time visibility into multiple process parameters and support the development of digital process models. With IoT-enabled lab development platforms, rapid algorithm-driven optimization and automated process characterization become possible, reducing development time while providing highly robust development data. Ideally, development data can be shared in real-time via digital collaboration platforms facilitating seamless communication and collaboration with external partners. Such an environment would facilitate collaboration and accelerate decision-making. In manufacturing, mapping the engineering specifications of all components of the process line and enabling real-time data acquisition from sensor arrays monitoring process parameters would allow for development of highly accurate digital twins.”
To see how other pharmaceutical executives are approaching a digital transformation, read the full article, “How can Life Science Technology Providers Support the Pharmaceutical Industry in the Transition Toward More Digitally Connected Operations?”
View the full article (via Pharma’s Almanac)
Pharma’s Almanac recently asked Cambrex’s Matt Bio, Chief Scientific Officer, how he viewed the current investment trends in the pharmaceutical industry and their influence on the sector’s direction.
While other vendors within the pharmaceutical value chain have lagged in developing actionable, time-based sustainability programs, Cambrex has implemented Environmental, Social, and Governance (ESG) programs aligned to our corporate goals, including top-line growth, cost reduction, and increased employee productivity – driving more value for us and our clients.
During DCAT Week 2024, Matt Bio, Chief Scientific Officer, outlined Cambrex’s recent $100M expansion activity at the DCAT Member Company Announcement Forum, outlining the investment in clinical and commercial drug-substance development and manufacturing adding capacity, new capabilities, and advanced technologies.