WuXi AppTec provides biologics testing services tailored to our customers' specific needs. Our vast array of testing services includes:
We are well positioned to ramp up quickly for projects and to be responsive to customer needs.
Product or reference standard analytical characterization is provided under R&D, GLP or GMP guidelines. Analytical methodologies for biopharmaceuticals include, but are not limited to SDS-PAGE, IEF, Western Blotting, HPLC, ELISA, AAA, Peptide Mapping, Mass Spectrometry, Flow Cytometry as well as carbohydrate analysis and extinction coefficient determination. Compendial methods such as UV/VIS Spectrophotometry, endotoxin, pH, visual appearance, Karl Fischer moisture determination, particulates determination and osmalility are also available. Client-specific assays for product identification, purity and potency could be transferred, developed and further optimized and validated as part of the product characterization program.
As a company with extensive experience in this area, WuXi AppTec can provide clients with the appropriate testing methodology to meet specific cell line testing needs. These services are available for complete biosafety, identification and characterization assessment of cell banks and cells at the limit of in vitro cell age under FDA and ICH guidelines. The comprehensive battery of test methodologies, including genetic stability analysis required for most species (Hamster, Murine, Human, Insect, Avian and Simian, etc.) can be conducted following GLP and, if appropriate, GMP protocols. These services can be provided for various biological products that use mammalian cell culture production systems at every phase of clinical development.
Understanding the critical need for timely lot release testing, WuXi AppTec supports bulk harvest, bulk drug substance and drug product testing with a comprehensive menu of services that includes both analytical and biosafety assays. Our scientists also offer the expertise to advise clients on testing options as well as to develop customized tests that meet special needs.
WuXi AppTec offers custom studies to validate removal, inactivation, or cleaning processes for viruses, bacteria, and mycoplasma agents, with studies performed for R&D, GLP or GMP as needed. Our scientific and quality teams have comprehensive expertise in virology, microbiology, infectivity and quantitative PCR assays, process development, and international regulatory considerations for early- and late-stage products with capabilities that meet client needs for Phase 1-3, BLA and 510K submissions.
Dedicated laboratories include:
Regardless the type of biopharmaceutical (proteins/ peptides, virus, nucleic acid), WuXi AppTec can design and implement comprehensive stability testing and storage programs to meet regulatory and client requirements. Our stability studies employ validated storage chambers, complete biosafety and analytical testing services, and dedicated project management oversight.
All temperature and humidity conditions needed to comply with ICH guidelines can be provided. Alternate custom conditions can also be created to meet special needs.