Presentations and Articles

Technical Information
Technical Presentations and Published Articles
The 4-(N-Dichloroacetyl-N-methylamino) benzyloxymethyl Group for 2’-Hydroxyl Protection of Ribonucleosides in the Solid-Phase Synthesis of Oligoribonucleotides Journal of Organic Chemistry, 2774-2783, 2008. Published by Dr. Jon S. Kauffman, Director, Biopharmaceutical Services and Dr. Robert J. Duff, Manager, Biopharmaceutical Services as well as Jacek Cieslak, Andrzej Grajkowski and Serge L. Beaucage of the FDA-CDER, Division of Therapeutic Proteins
Clearing the Air on Residual Solvents Pharmaceutical Technology February 2008 Editorial comments by Travis Emig, Director, Pharmaceutical Sciences and Delwyn Schumacher, Principal Chemist, Analytical Method Development and Validation
Outsourcing Analytical Testing Contract Pharma September 2007 Editorial comments by Tim S. Oostdyk, Ph.D., COO, Lancaster Laboratories
Analytical Testing to Support Biopharmaceutical Products by Jon S. Kauffman, Ph.D., Director of Anayltical Method Development and Validation and Biopharmaceutical Services The BioPharm International Guide April 2007
Identification and Risk-Assessment of Extractables and Leachables by Jon S. Kauffman, Ph.D., Director of Anayltical Method Development and Validation and Biopharmaceutical Services Pharmaceutical Technology Primer January 2006
Qualification and Validation of USP Apparatus 4 by Jon S. Kauffman, Ph.D., Director of the Analytical Method Development and Validation Group Dissolution Technologies May 2005
Outsourcing Water System Validations: Key Points from a Microbiological Perspective by Harolyn Clow, M.S., SM (NRM) Manager, Pharmaceutica Microbiology
Determination of Extractables, Leachables, Residual Solvents, and Unknowns by Mass Spectrometry by Jon S. Kauffman, Ph.D., Director of the Analytical Method Development and Validation Group Pharmaceutical Technology August 2003