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5 services found
Manufactured by:Catalent, Inc based inSomerset, NEW JERSEY (USA)
At Catalent, our methodologies work toward reducing the overall costs and time it takes to get your product to the clinic. With decades of experience in analytical development, we understand our clients’ needs, the current regulatory environment, and have a history of the development and qualification of analytical methods. We operate with a forward-looking methodology by deploying robust ...
Manufactured by:Minaris Regenerative Medicine, LLC based inAllendale, NEW JERSEY (USA)
Minaris Regenerative Medicine’s manufacturing development services help you to design efficient and robust manufacturing processes for your cell and gene therapy. Keeping the ultimate goal of commercial supply in mind, we help you think beyond your current manufacturing needs to create approaches that improve the commercial viability of your products. We keep in mind four key elements of ...
Manufactured by:Catalent, Inc based inSomerset, NEW JERSEY (USA)
Drug product development can be a daunting and expensive process. Biotech companies face many hurdles along the way, including the development and optimization of a scalable, commercially viable formulation while ensuring safety and efficacy of the final drug product. In order to receive regulatory approval, the manufacturing process and validation methods used to evaluate the drug product ...
Manufactured by:Cambrex Corporation based inEast Rutherford, NEW JERSEY (USA)
Cambrex has extensive experience in Drug Metabolism and Pharmacokinetic (DMPK), Bioanalytical and Biopharmaceutical Analyses. The Biopharmaceutical Analyses scope supports GMP method development, validation, and routine analysis including but not limited to host cell proteins, host cell DNAs, endotoxins, enzyme kinetics, and even bacteriophage titering assays. The Drug Metabolism and ...
Manufactured by:Cambrex Corporation based inEast Rutherford, NEW JERSEY (USA)
Bioanalysis with an expert perspective: At Cambrex we’ve got the tools, insight and world-class expertise to support your demanding biopharmaceutical testing needs. We work closely with biotech start-ups and established biopharma companies to evaluate the quality, purity, safety and other key attributes of candidate viral therapies and large molecules at all phases of the preclinical and ...