BioAgilytix, a leading bioanalytical testing laboratory specializing in immunoassays and cell-based assays, announced today our support of development and release testing for biosimilar large molecule therapeutics. “Our expanded capability and capacity to perform assay development and validation under GLP and GCP along with release testing under GMP broadens our technical offerings to our clients while allowing us to continue to deliver the highest quality bioanalysis possible. With the ever growing market for biosimilars, clients will need these testing services more than ever,” Dr. Afshin Safavi, Founder and Chief Scientific Officer at BioAgilytix.
Unlike their small-molecule counterpart (generics), biosimilars generally exhibit high molecular complexity and may be quite sensitive to changes in manufacturing processes. Biosimilar manufacturers do not have access to the originator’s molecular clone and cell bank, the exact fermentation and purification process, or the active drug substance. This has created a concern that copies of biologics might perform differently than the original branded version of the product.
Dr. Safavi notes that “BioAgilytix’ experienced scientific team is aware of the challenges that face biosimilar developers, which allows us to take a consultative approach with our clients.” Test validation and product release testing for biosimilars requires skilled and knowledgeable scientists; and advanced platform technologies such as ELISA, MSD – ECL, Gyros, and BioRad (Luminex) xMAP are also necessary to produce a biosimilar product. BioAgilytix has the veteran manpower and the instruments and techniques implemented and validated in order to quickly progress the development of any biosimilar product.
About BioAgilytix www.bioagilytix.com
BioAgilytix is a leading bioanalytical testing laboratory specializing in large-molecule bioanalysis. Located in North Carolina’s Research Triangle, BioAgilytix provides PK, immunogenicity, biomarkers, and cell-based assays services supporting the development and release testing of biologics and small molecule therapeutics. BioAgilytix offers assay development, validation, and sample analysis under non-GLP, spirit-of-GLP, and GLP, as well as product release testing under GMP.
Our team of highly experienced scientific and QA professionals ensures high quality science, sample and data integrity, and regulatory compliance through all phases of clinical development enabling BioAgilytix to become a trusted partner to 6 out of the top 10 global pharmaceutical and biotech companies.