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.
04.09.2021
Waltham, MA – April 9, 2021 – Snapdragon Chemistry has been highlighted in PharmTech’s April Cover Story on advanced manufacturing technologies.
See below for Snapdragon’s inclusion in the article:
“Continuous flow chemistry is one of the intensified, agile technologies showing promise, with some good manufacturing practice (GMP) lines running commercially and other novel processes in development.”
“Snapdragon Chemistry, a 2014 spinoff from the Massachusetts Institute of Technology (MIT) based in Waltham, Mass., has developed flow-based API manufacturing processes. In mid-2020 the process development company doubled its R&D capacity and opened a lab to produce gram to kilogram-scale APIs and demonstrate its continuous flow manufacturing technology at pilot scale. The company began construction in January 2021 of a GMP drug substance manufacturing facility, which it plans to commission in November 2021. The facility would be set up for commercial production of APIs using processes designed by Snapdragon.”
“In a collaboration with BARDA that began in June 2020, the company developed a synthetic continuous manufacturing route for ribonucleotide triphosphates, which are a raw material for mRNA-based COVID-19 vaccines. Snapdragon is initiating discussions with prospective users, and the materials could be produced in the new commercial facility, says Matt Bio, CEO of Snapdragon.”
“In a separate project launched in February 2021, Snapdragon is using a $1.5 million DARPA grant to extend its technology to enable efficient US-based production of chemicals used in pharmaceutical production. “We’ve identified a set of chemical building blocks that can be produced on the same process-equipment setup using only programming changes, and we are developing a continuous manufacturing platform with next-generation automation to accomplish this goal,” explains Bio. The platform is currently in the R&D stage, and Bio anticipates that it could be commercialized within two years.”
Read the full article (via PharmTech)
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.