Abstract

Contaminants, such as microparticles, found in the manufacturing stream of biopharmaceuticals must be identified and the source determined in order to take corrective actions.  Biopharmaceuticals differ significantly from conventional pharmaceutics in the manufacturing and delivery.  They are produced by molecular cloning and cell culture fermentation, purified by multiple HPLC runs, and formulated as injectables to bypass the digestive system.  Each step in the process presents different contamination risks.  Contaminant incidents can lead to production slow down, quarantine of material and even product loss.  For final products delivered in liquid formulation any visible contamination is unacceptable.  Our laboratory employs multiple micro-spectroscopic techniques to investigate and identify unknown materials that are involved in contaminant incidents.  The techniques include, but are not limited to, optical microscopy, FTIR-microscopy, and scanning electron microscopy (SEM) with energy dispersive x-ray spectrometry (EDS).  Several archetypical incident investigations will be presented to demonstrate the challenges and the diversity of the manufacturing incidents, as well as the capability and flexibility of the combination of micro-spectroscopic techniques to address specific challenges in the biopharmaceutical industry.

 Biography

Gianpiero “Gianni” Torraca is currently a Sr. Scientist in the Amgen Forensic Analysis Group working on identification of extraneous matter and advantageous materials in the biopharmaceutical environment as well as surface characterization.   He has worked at Amgen for 7 years and previously was at Schering Plough Research Institute for 10 years.  Education includes MS Chemistry from Seton Hall University, BS Chemistry from William Paterson University and currently enrolled in an MBA program at California Lutheran University.