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.
If you’re looking to outsource drug product development to a CDMO, you need a collaborative partner who will engage you deeply to understand the unique needs of your project.
From pre-formulation to commercial manufacturing and packaging, you can trust Cambrex to deliver your complex dosage forms with the perfect combination of technology, expertise, and collaboration.
At Cambrex, we offer a tried and trusted approach to technology transfer, for scale-up or when transitioning to a different facility.
We are equipped to take on projects at any size or scale, offering established pediatric formulation and development expertise and to-scale manufacturing capabilities.
Biopharma companies at all stages of development, rely on our expertise and broad capabilities to produce the clinical trial supply of drug products they need, when they need them.
We can support you, at any size or stage, with a range of primary and secondary packaging solutions.
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 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.
Waltham, MA – July 7, 2021 – Snapdragon Chemistry today announced the hiring of Dr. Hui Fang as the company’s Director of Attribute Sciences and Quality Control. As a part of the company’s leadership team, Dr. Fang will lead the Snapdragon’s analytical group to offer a suite of analytical services for customers’ clinical and commercial assets, and the GMP QC lab, which is scheduled to open in Q1 2022 in Waltham, Massachusetts.
“Hui brings us with over a decade of experience in development and manufacturing for clinical and commercial pharmaceutical drug substances and drug products,” says Snapdragon Chief Scientific Officer Eric Fang. “With his expertise in analytical sciences and GMP quality control, and an impeccable track record of marketed drugs and research publications, Hui will bring tremendous value to Snapdragon and our clients. As we continue our rapid expansion in process development and GMP manufacturing, his expertise will meet the customers’ analytical needs from IND to NDA.”
“I am thrilled and honored to join such a stellar team of scientists and engineers, and to lead the analytical team to enhance Snapdragon’s offering in analytical development and quality control,” said Dr. Fang. “Snapdragon is a well-known brand, an industry leader when it comes to innovation and technology. I am excited to apply my knowledge in elevating their platform, delivering quality products to clients, and leading projects in the new GMP lab facility at 360 Second Avenue.”
Dr. Fang brings years of experience and an in-depth knowledge of pharmaceutical R&D and regulatory compliance to Snapdragon. During that time, he gained a reputation for exceptional project management skills, problem-solving, expertise of drug analysis and characterization by various analytical technologies.
Dr. Fang comes to Snapdragon after almost two years as Associate Director, CMC Analytical Development at Akebia Therapeutics in Cambridge, MA. At Akebia, he led analytical scientists to support day-to-day commercial manufacturing operations of Auryxia® drug substance and drug product by seven CMOs in multiple countries. He also provided scientific guidance and technical oversight for CMOs, CROs and CDMOs including method development, analytical testing and reporting, and trend analysis.
Prior to that, Dr. Fang worked his way from scientist to principal scientist at Eisai Inc. in Andover, MA, leading an impressive list of clinical and commercial-stage small molecules and biologics projects. Noticeably, Dr. Fang is a part of the team to bring a highly complex small molecule cancer therapeutics Halaven® (erbulin mesylate) to the market.
Dr. Fang obtained his Ph.D. from University of Pittsburg and B.Sc. M.Sc. from Nankai University in Tianjin, China. He is also affiliated with American Chemical Society (ACS) and American Association of Pharmaceutical Scientists (AAPS).
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 email@example.com.