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 – April 7, 2020 – Cambrex, the leading small molecule company providing drug substance, drug product and analytical services across the entire drug lifecycle, today announced it has completed an expansion of its biopharmaceutical analysis capabilities at the Durham, North Carolina site. Biopharmaceutical analysis services were initially launched at Durham in 2018 and have since been expanded through the purchase and implementation of various method development, validation, release and stability or endotoxin testing functions.
Following this expansion the Durham site now features a range of new instruments, including particle analysis, imaging, qPCR, fluorescent/absorbance plate reader, immunoblotting, mass spectrometry and other compendial testing apparatus. The new capabilities are applicable to a broad variety of biopharmaceuticals, including bacteriophage/bacterial virus and mammalian viral infectious titer assays for intermediates, drug substances, and final drug products.
“The expansion began in response to a customer request to support a BioSafety Level 1 (BSL1) organism and grew from there based on broader customer response,” said Elliott Franco, Durham Site Director, Cambrex. “We remain committed to adopting the best-in-class technologies customers need access to. Our comprehensive expertise, coupled with a transparent, safety-driven approach to implementing the new equipment, allow the Cambrex team to better serve customers across the life of their processes.”
All new capabilities comply with current good manufacturing practice (cGMP) standards, as well as meeting International Conference on Harmonization (ICH) Q2 and United States Pharmacopeia (USP) guidelines for validating biological assays, and ICH Q6B test procedures for biological products. Existing safety and containment practices for BSL1 and BSL2, and some BSL2+, at the Durham site allow support for a wide range of active ingredients.
Ongoing assay additions are also planned at Durham, including impedance based orthogonal methods for existing and new cell-based potency assays, and protein-protein interaction/binding assays.
Cambrex is the leading small molecule company that provides drug substance, drug product and analytical services across the entire drug lifecycle. The company provides customers with an end-to-end partnership for the research, development and manufacture of small molecule therapeutics. With over 35 years’ experience and a growing team of over 2,000 experts servicing global clients from sites in North America and Europe, Cambrex is a trusted partner in branded and generic markets for API and dosage form development and manufacturing.
Cambrex offers a range of specialist drug substance technologies and capabilities including biocatalysis, continuous flow, controlled substances, solid state science, material characterization 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 specialist dosage forms such as modified-release, fixed dose combination, pediatric, bi-layer tablets, stick packs, topicals, controlled substances, sterile and non-sterile ointments.
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