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.
Cleanrooms are designed to minimize contamination, which is critical in the production of high-quality pharmaceutical products and medical devices. Scientists from our Agawam, MA site perform environmental monitoring and cleanroom services throughout the New England region and the greater Albany, NY area in tightly controlled environments that minimize contamination. We work with you to identify your testing needs and build a well-designed, risk-based environmental monitoring program, including services such as total air particulate testing, viable surface and air testing and compressed gas testing.
Our scientists will sample water systems and return those samples to our Agawam facility for Total Organic Carbon (TOC), conductivity, nitrate, bioburden and endotoxin analyses.
As part of our comprehensive environmental monitoring and critical utility testing, support and services, we ensure the quality of your manufacturing environments specific to API, aseptic or oral dose manufacturing, as well as terminally-sterilized medical device and component manufacturing.
Whether you’re looking for routine environmental monitoring, certification, validation or training, we offer a wide variety of services to ensure your needs are met, including the following:
Our experts will work with you to define your program, from frequency and duration of testing to specific methods and sampling plans.
We will partner with your team to identify hazards and evaluate the risks associated with maintaining your facility’s control of microbiological contamination.
Cambrex’s cGMP-trained analysts provide full technical oversight for cleanroom qualifications and certifications — from start to finish.
Our experienced scientists can support your organization’s compliance with cGMP regulations and assist with establishing the testing program and parameters based on your needs.
Using genetic sequencing or MALDI-TOF mass spectral analysis, our state-of-the-art lab can identify specific species of bacteria, fungi and yeasts.
We deliver quality control-tested media for your use, and then conduct incubation and analysis after the plates are returned.
We provide a courier service available to clients located in the New England area, and portions of New York, within a 150-mile radius of the Agawam facility. Our experts will pick up and deliver your samples to our laboratory for analyses.
If you’re interested in our courier services in the New England area, please complete the Courier Request Form.
Ensure microbial control in the production environment through robust environmental monitoring, microbial identification and trending, and the use of proven cleaning protocols.
Cambrex is the industry leader in testing, validating, and monitoring controlled environments. Our experts will work with you to
define your program from frequency and duration of testing to specific methods and sampling plans.
When analyzing environmental monitoring data, the microbial identifications are just as, if not more significant, than the counts recovered and pose a threat to operations depending on the identifications.
Our scientists specialize in making connections. Start a conversation today and ask us about our environmental monitoring and related cleanroom services.
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