Primera Analytical Solutions Corporation
Linjie Bai serves as Group Lead and Scientist III at Primera Analytical Solutions Corporation since September 2017, managing projects from ANDA to commercialization, in-vitro stability products, and US pharmacopeia research, while demonstrating proficiency in chromatographic and wet chemistry tests. Prior experience includes roles as Environmental Scientist at Advanced Environmental Laboratories, contributing to IC and TOC analysis, and as a Volunteer Research Assistant at the University of Florida, focusing on the dynamic mechanisms of non-colloidal suspensions. Linjie also gained experience as a Process Engineer Intern at Selon Industrial Co., Ltd, and served as Research Team Leader at Jiangxi Normal University, analyzing rare-earth polymer properties. Educational background includes a Master’s Degree in Chemical Engineering and a Minor in Statistics from the University of Florida, along with a Bachelor's Degree in Materials Chemistry from Jiangxi Normal University.
Primera Analytical Solutions Corporation
Primera Analytical Solutions is a GLP and GMP CRO in great standing with the FDA. Our primary objectives are quality and to become a trusted partner. Services include: - Large and small molecule CMC, bioanalytical, release testing. Method development/validation, method transfer (Assay, Impurities, Dissolution, PK/PD, ADA, cell-based/non cell-based NAb) - Cell & Gene Therapy (FACS, qPCR, ddPCR, cell-based assays - Cell potency assays - Impurity studies (LC/MS/MS, GC/MS, ICP/MS) - Extractable and leachable studies - Stability studies - Dissolution - Abuse-deterrent studies - Solid state characterization - Product and raw material release testing - Metabolite characterization, bioavailability and bioequivalence studies - Bioassay method development and validation - Impurities by ELISA - Peptide mapping - HRMS