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.
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.
07.08.2024
East Rutherford, NJ – July 8, 2024 – Cambrex today announced the expansion of its stability storage business, Q1 Scientific, which offers environmentally-controlled stability storage services to the pharmaceutical, medical device, and life sciences industries. Q1 Scientific will open a new state-of-the-art facility in Durham, North Carolina before the end of 2024, featuring advanced storage capabilities and co-located next to the existing Cambrex analytical facility.
The new Durham facility will initially offer 7 ICH stability chambers, covering a range of conditions including 2-8°C, 25°C/40%RH, 25°C/60%RH, 30°C/65%RH, and 40°C/75%RH, as well as both -20°C and ultra low (-70°C/-80°C) storage conditions. The phase 2 expansion, planned within the next 24 months, will increase the facility’s capacity to 20 chambers, with the potential for 20,000 cubic feet of storage space when complete. The facility’s Research Triangle Park (RTP) location in North Carolina will provide same day and next day delivery across the US.
Tom Loewald, CEO at Cambrex, stated, “We are thrilled to expand Q1 Scientific’s reach into Durham, North Carolina, enhancing our ability to serve pharmaceutical companies across North America. This investment not only broadens our footprint but also leverages Q1 Scientific’s extensive expertise in the stability storage business.”
Q1 Scientific’s expansion into Durham complements its existing facilities in Waterford, Ireland, and Liège, Belgium, giving it a global footprint with three locations covering both sides of the Atlantic Ocean.
Stephen Delaney, Managing Director of Q1 Scientific, added, “Operating three sites globally will be a significant benefit to our customers, who can now expect faster turnaround times for the return of samples and greater temperature-controlled transport options across the US and Europe.”
Cambrex continues to expand its capabilities and capacity across its North American and European network to meet the growing demand for outsourced drug development and manufacturing services.
About Cambrex Cambrex is a leading global contract development and manufacturing organization (CDMO) that provides drug substance development and manufacturing across the entire drug lifecycle, as well as comprehensive analytical and IND enabling services.
With over 40 years of experience and a team of 2,000 experts servicing global clients from North America and Europe, Cambrex offers a range of specialized drug substance technologies and capabilities, including continuous flow, controlled substances, solid-state science, material characterization, and highly potent APIs.
About Q1 Scientific, a Cambrex company Q1 Scientific, a Cambrex Company, is a leading provider of environmentally controlled stability storage services for the pharmaceutical, medical device and life sciences industries. With a decade of expertise, Q1 Scientific safeguards critical breakthroughs and life-changing innovations at state-of-the-art facilities in Ireland and Belgium. By utilizing Q1 Scientific’s services, companies can accelerate the introduction of new drugs to the market while avoiding the expense of building and monitoring their own storage chambers. In June 2022, Q1 Scientific was acquired Cambrex.