Stability Services

Comprehensive platform and flexible programs to support process development, manufacturing, and regulatory filings. 

Nitto Avecia Pharma Services provides expert, rapid analysis of all three classes of residual solvents. Our USP/ICH compliant, state-of-the-art laboratory, and experienced team of scientists allow you to manage the large number of methods that may be involved in identification and quantification of impurities, including residual solvents.

Physico-chemical characterization to support CMC/IND submissionReference standard testingMethod development and phase-appropriate validationPre-clinical to commercial phase release and stability programs to support IND and BLA submissionBiosimilar product testing

With over 10 years’ industry experience per structural scientist, Nitto Avecia Pharma Services’ strategic, systematic approach provides high-quality solutions for identification, characterization, and development of highly-sensitive methodologies.

Expansive services in dissolution, mercury analysis, container/closure testing, osmolality, melting point determination, nitrogen analysis, viscosity determination, and more.

Extensive analytical method development and validation services.

The cell lab is comprised of personnel trained in cellular biology, immunology, molecular biology, and virology. Expertise includes:Mammalian cellsMaintenance, freezing, and storageSeeding density, passage scheduling, culturing/freezing reagents

State-of-the-Art Instrumentation with product characterization expertise means comprehensive biopharmaceutical support.

Our experienced staff can help you:Develop/transfer, validate and test elements listed in <232> and beyondPerform a general screening for elements listed in <232> and beyond (for informational purposes only)

Investigate the potentially harmful effects of your container/closure/single-use systems on your drug product by partnering with Nitto Avecia Pharma Services. Our team of structural scientists have over 20 years of experience with polymers, organic and elemental impurities, and an array of pharmaceutical products to assist in identifying the threat of contamination to your drug products.

With nearly 30 years’ experience in supporting all compendial microbiological testing, Nitto AveciaPharma Services has the in-depth experience, established quality systems, and expertise to bestsupport your product life cycle at any stage.