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.
07.07.2021
Waltham, MA – July 7, 2021 – Snapdragon Chemistry and Shimadzu Corporation have agreed to enter a strategic collaboration to jointly support pharmaceutical and chemical industries by providing advanced solutions for improved efficiency in chemical synthesis.
The companies have complementary core technologies which, when combined, can produce unique and useful solutions. The strategic collaboration aims to help chemical manufacturing processes become more cost effective, safer and easier. As the first step, the companies fully integrated automated process sampling with Ultra-High Performance Liquid Chromatography (UHPLC) in a compact footprint appropriate for real-time process analytics. This will drastically shorten the time and cost needed to optimize synthetic conditions without requiring human intervention. The system consists of the Sample Relay System (SRS), Snapdragon’s proprietary solution for automated at-line chromatography; EasySampler, Mettler Toledo’s sampling device; and Nexera FV, Shimadzu’s flow vial UHPLC system providing both sensitivity and specificity not currently available from traditional spectroscopic Process Analytical Technologies.
Snapdragon uses the SRS technology with its proprietary software platform for AI applications, such as autonomous algorithm-driven process optimization for continuous and batch bioprocesses. The combination of SRS, EasySampler, and Nexera FV results in real-time UHPLC, a powerful technique that enables monitoring of reaction kinetics and product quality attributes for accelerated process development.
The partnership brings Snapdragon’s expertise in continuous manufacturing and IoT technology to one of the world’s largest manufacturers of analytical instrumentation and environmental monitoring equipment. Shimadzu is a $4B multinational corporation with major divisions in medical diagnostics, aerospace/industrial, and analytical instruments.
“We could not be more excited about this partnership with Shimadzu to bring our innovative SRS solution to market,” says Snapdragon Chemistry President/CEO Matthew Bio. “Shimadzu’s reputation for excellence and innovation in the scientific field is world-renowned making them a natural partner to introduce this technology.”
“Partnering with Shimadzu enables Snapdragon to access an incredibly information-enrich chromatographic data set that is ideal for applying machine learning tools in chemical process development and product quality control in advanced biopharmaceutical manufacturing,” says Snapdragon Chief Scientific Officer Eric Fang.
“Online liquid chromatography has been the ultimate, long sought-after Process Analytical Technology tool, but technical challenges made a general solution elusive. Snapdragon Chemistry’s Sample Relay System (SRS) solves this problem through the use of sophisticated technology and creative design that finally enabled this breakthrough, and we are excited about the opportunities this partnership will provide us,” says Masayuki Nishimura, Director of New Strategy Department, at Shimadzu Scientific Instruments, Inc., a fully owned U.S. subsidiary of Shimadzu Corporation.
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.
About Shimadzu Corporation Based in Kyoto and established in 1875, Shimadzu produces world-class analytical and measuring instruments, medical systems, vacuum, and industrial machinery, hydraulic equipment, aircraft equipment, and optical devices. Shimadzu collaborates and partners with corporations, researchers, and institutions to provide solutions to societal challenges in clinical medicine, food safety, and the environmental/energy industries.