24 Years
LTI Welcomes New Project Director, John Stewart
John joined LTI as an Associate Scientist in August 2016 and is excited to be a part of the team.  He is involved in conducting client projects including product and process development, technical support, and troubleshooting, as well as clinical manufacturing.
John attended Delaware State University majoring in Biotechnology.  While attending DSU he participated in several internships in the fields of cellular biology, synthetic chemistry, and behavioral sciences.  John furthered his education in the Masters of Pharmaceutical Sciences program at the University of Kansas in the lab of Dr. Teruna Siahaan where he completed a master thesis entitled:  "MOG-I-domain Drug Antigen Conjugates (MOG-IDAC) for suppressing MOG-Stimulated Experimental Autoimmune Encephalomyelitis (EAE)."
John began his professional career in the Department of Formulation Sciences at Medimmune where he was in charge of conducting and planning experiments for early stage development and lyophilization process development.
John M. Stewart
Associate Scientist, Project Director
October 4, 2016
In The Know

Welcome to Lyophilization Technology, Inc.'s news announcement!

Our goal is to provide you with industry updates on a routine basis. Each update of "In The Know" will bring you news of industry presentations, conferences, and educational information.

We hope you enjoy Lyophilization Technology Inc.'s (LTI) "In The Know". Keep a watch out for our next quarterly update of the latest news!
LTI Project Team Focuses on Identifying TPP for Lyophilized Parenterals

Considerations in product design concepts introduced in CFR 820 and expanded for drug development in ICH Q8 have brought greater attention to identifying Target Product Parameters (TPP).  Also referred to as Quality Target Product Parameters (QTPP), identifying product attributes provides focus during development.  This encompasses identifying those attributes that are deemed desirable and essential.
A project team at LTI comprised of Carrie Shults, Development Sciences, Denise Miller, Quality Assurance, and Ed Trappler, President, has been researching aspects and considerations in identifying TPPs for lyophilized preparations.  Product design aspects with an emphasis on the intended use that includes considerations such as therapeutic indication, therapy regimen, and route of administration are factors that direct identifying product design objectives.  These objectives are so crucial for discerning product attributes that are desired as compared to those that are essential.  A hierarchy of product characteristics, their relationships to the general requirements for a parenteral product, and those unique to a lyophilized preparation has been developed to highlight the various considerations in design for a lyophilized product.
A presentation of the hierarchy that outlines product design attributes and considerations has been presented at the PDA Annual Meeting, with additional presentations at the DIA, CPPR Conference on Freeze Drying of Pharmaceuticals and Biologicals and AAPS conferences for soliciting comments and feedback.  It is becoming clear that product attributes are strongly influenced by the intended use; those essential for some products are simply desirable for others.  To request a copy of the presentation, click here.

Upcoming 2016 Events:
30 Indian Drive  Ivyland, PA 18974-1431 USA
(215) 396-8373  FAX (215) 396-8375   www.lyotechnology.com  

Home   /  About   /  Contact