LSNE Contract Manufacturing
LSNE Contract Manufacturing is a CMO with a proven regulatory history specializing in a wide range of services including formulation/lyophilization development, fill/finish, and lyophilization. Through the integration of three facilities, qualified staffing, and an extensive manufacturing history, LSNE is strategically positioned to provide uninterrupted material for clinical through commercial use.
LSNE Contract Manufacturing
23 Commerce Dr., Bedford, NH 03110
info@lyophilization.com
tel. 603.668.5763
INTERPHEX Booth #1338
Specification Equivalence—A Practical Approach
December 30th 2024In this first of a four-part series, the authors provide an introduction to a practical approach for establishing specification equivalence. The regulatory basis and compliance examples from FDA observations and warning letters are included to support the need for an effective process.
