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.
07.24.2020
Waltham, MA – July 24, 2020 –
Snapdragon Chemistry recently announced the doubling of its research and development as the first phase of a two-phase expansion program. New kilo-lab suites enable bulk deliveries and full-scale flow demonstration processes. Phase two of the expansion, already underway and expected to commission in mid-2021, will add GMP drug substance manufacturing suites.
Matt Bio, CEO of Snapdragon Chemistry, said “the demand for our services was outstripping our capacity to deliver in a timely fashion. This expansion is allowing us to expand our research and analytical development capacity. We are also excited about the new capacity for pilot-scale demonstrations and bulk product deliveries. The next phase – adding GMP manufacturing – will be a key capability in our fast-to-clinic vision.”
Chief Scientific Officer, Eric Fang, commented that “the newly opened R&D to kilogram delivery lab was designed with special capabilities and flexibility in mind for the rapid delivery of kilogram APIs through our market-leading continuous flow manufacturing technologies. The state-of-the-art laboratory is equipped with a 5kw photoreactor, ultra-high-temperature, high-pressure flow reactors, alongside traditional batch reactors. More importantly, the laboratory is run on a proprietary smart LabOSTM information system for automation and near real-time data acquisition.”
About Snapdragon Chemistry Snapdragon Chemistry specializes in active pharmaceutical ingredient (API) batch and continuous flow process development, utilizing state-of-the-art automation technology and proprietary equipment to solve complex process and analytical development challenges. With R&D and manufacturing headquartered in Waltham, Massachusetts, Snapdragon’s 70+ employees come with strong ties to the local scientific community, with 31 PhD scientists on staff. For more information, please contact info@snapdragonchemistry.com.