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.
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 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.
Whether you’re with a biotech start-up or an established biopharma company, you need to evaluate the quality, purity, safety and other key attributes of candidate biological products through all phases of the preclinical and clinical development pipeline.
Cambrex offers a comprehensive suite of testing services for complex biopharmaceutical/biotherapeutic products that include large biomolecules such as monoclonal antibodies (mAbs), antibody-drug conjugates (ADCs), RNA/DNA oligonucleotides, recombinant proteins/enzymes, peptides, lipids/micelles/vesicles (liposomes/exosomes/LNPs) and polysaccharides but also include biologics such as live/attenuated viruses (mammalian, bacteriophage, AAV/LVV) and live/attenuated bacteria. Our biopharmaceutical services include standalone analytical research and development, method validation, release testing, ICH stability and routine QC testing.
Our robust testing capabilities for large molecules and biologics include:
We use the following tools and technologies to conduct testing:
Our experts specialize in testing services that include:
Our teams of expert technicians design quality assurance programs to comply with:
We handle the logistics of quality assurance testing, including:
Trust the analytical development and testing experts at Cambrex to rapidly advance your biologic for the greatest chance of success. Led by our deep experience and collaborative approach, we are committed to finding the shortest, most efficient path to success for our customers.
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If you have any questions, please feel free to get in touch with one of Cambrex’s experts.
Securing end-to-end biopharmaceutical testing services has become increasingly challenging for biopharma companies at all stages of development. Learn why it is often advantageous for them to leverage a single laboratory for analytical services.
Our analytical development and testing experts are here to help you rapidly advance your biologic for the greatest chance of success.
In this webinar, we explain why stability is particularly challenging for biopharmaceutical products, an approach for the design of a stability study, and typical degradation mechanisms for these product types.