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 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.
East Rutherford, NJ – October 4, 2022 – Cambrex today announced the expansion of their 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 20,000-square-foot cGMP facility in Belgium and add an additional 10,000 square feet at their existing facility in Waterford, Ireland. The expansions will be completed in the first half of 2023.
Q1 Scientific’s new state-of-the-art temperature-controlled and monitored storage facility in Belgium will be located in the easily accessible Liege region, approximately 50 miles from Brussels. The facility will provide 35,000 temperature-controlled storage spaces for all key ICH climatic zones, supporting long-term, intermediate and accelerated stability trials, including 2 – 8°C and 25°C / 60%RH and 40°C / 75%RH.
Tom Loewald, CEO at Cambrex says, “We are delighted to expand the Q1 Scientific business into Belgium, where we will be able to serve pharmaceutical companies across Germany, France, and the Netherlands. Simultaneously, we will continue to expand our Waterford facility to meet the demand within the Irish market.”
Q1 Scientific’s Waterford-based facility has doubled in size over the past two years and continues to grow with this new 10,000-square-foot expansion.“ With Cambrex’s scientific expertise and scale, we are able to accelerate our growth plans and launch a second site in 2023,” added Stephen Delaney, Managing Director of Q1 Scientific. “Operating two sites will be a great benefit to our European customers, who can now expect even faster turnaround times for the return of samples. Meanwhile, we will also be able to provide greater temperature-controlled transport options in mainland 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.
Cambrex is a leading global contract development and manufacturing organization (CDMO) that provides drug substance, drug product, and analytical services across the entire drug lifecycle. With over 40 years of experience and a growing team of over 2,300 experts servicing global clients from North America and Europe, Cambrex is a trusted partner in branded and generic markets for API and finished dosage form development and manufacturing.
Cambrex offers a range of specialized drug substance technologies and capabilities, including biocatalysis, continuous flow, controlled substances, solid-state science, material characterization, stability storage, and highly potent APIs. In addition, Cambrex can support conventional dosage forms, including oral solids, semi-solids, and liquids, and has the expertise to manufacture specialty dosage forms such as modified-release, fixed-dose combination, pediatric, bi-layer tablets, stick packs, topicals, controlled substances, sterile, and non-sterile ointments.
About Q1 Scientific, a Cambrex company
Q1 Scientific, a Cambrex company, was founded in Waterford, Ireland in 2013 by Louise Grubb, and offers environmentally controlled stability storage services to the pharmaceutical, medical device and life sciences industries at their 20,000 sq ft. cGMP facility. As the first company in the sector to establish in Ireland, Q1 Scientific is revolutionising the way pharmaceutical companies store their products, helping to improve the speed it takes for new drugs to reach the marketplace along with saving companies the expense of building and monitoring their own storage chambers. In June 2022, Q1 Scientific was acquired by US company Cambrex.