Biopharmaceutical Published Articles

Perspectives on Method Validation: Importance of adequate method validation
Pharmaceutical Formulation Quality, December/January 2010

Authors:
Heather Bridwell - Group Leader/Chemist
Vikas Dhingra, PhD - Group Leader/Biochemist
Daniel Peckman, PhD - Group Leader/Biochemist
Jennifer Roark - Group Leader/Chemist
Thomas Lehman, PhD - Manager of Method Development

Analytical Strategies for Monitoring Residual Impurities -
Best methods to monitor product-related impurities throughout the production process.
Biopharm International, January 2010

Author:
Jon S. Kauffman, Ph.D.
Director of Biopharmaceutical Services and
Analytical Method Development / Validation

10th Anniversary Special-Having Your Say
Contract Pharma, October, 2009

Editorial comments:
Eric Hoffman
Senior Director of Business Development and Strategic Marketing

Health Care Report 2009: Biotech companies innovate in the midstate
Central Penn Business Journal, June, 2009

Editorial comments:
Michael McDowell
Director, Biopharmaceutical Business Development

CRO Roundtable - The Future Of The CRO-Pharma Relationship
Life Science Leader, March 2009

Editorial comments:
Timothy Oostdyk, Ph.D.
Executive Vice President and COO, Lancaster Laboratories

Navigating the complexities of biologic
Good Clinical Practice Journal, October 2008

Authors:
Sean Smith, Ph.D.
Vice President of Clinical Supply Chain, Fisher Clinical Services
Timothy Oostdyk, Ph.D.
Executive Vice President and COO, Lancaster Laboratories

Thermolytic Release of Covalently Linked DNA Oligonucleotides and Their Conjugates from Controlled-Pore Glass at Near Neutral pH
Bioconjugate Chemistry, 2008

Contributing authors:
Jon S. Kauffman, Ph.D.
Director of Biopharmaceutical Services and
Analytical Method Development / Validation
Robert J. Duff, Ph.D.
Manager, Biopharmaceutical Services

The 4-(N-Dichloroacetyl-N-methylamino)benzyloxymethyl Group for 2'-Hydroxyl Protection of Ribonucleosides in the Solid-Phae Synthesis of Oligoribonucleotides.
Journal of Organic Chemistry, 2008

Contributing authors:
Jon S. Kauffman, Ph.D.
Director of Biopharmaceutical Services and
Analytical Method Development / Validation
Robert J. Duff, Ph.D.
Manager, Biopharmaceutical Services

Outsourcing Analytical Testing
Contract Pharma, September 2007

Editorial comments:
Tim S. Oostdyk, Ph.D., COO
Lancaster Laboratories

Solid-Phase Synthesis of Thermolytic DNA Oligonucleotides Functionalized with a Single 4-Hydroxy-1-butyl or 4-Phosphato-/Thiophosphato-1-butyl Thiophosphate Protectin Group
Journal of Organic Chemistry, 2007

Contributing authors:
Jon S. Kauffman, Ph.D.
Director of Biopharmaceutical Services and
Analytical Method Development / Validation
Robert J. Duff, Ph.D.
Manager, Biopharmaceutical Services

Assessment of 4-Nitrogenated Benzyloxymethyl Groups for 2'-Hydroxyl Protection in Solid-Phase RNA Synthesis
Organic Letters - American Chemical Society, 2007

Contributing authors:
Jon S. Kauffman, Ph.D.
Director of Biopharmaceutical Services and
Analytical Method Development / Validation

Michele J. Kolodziejski
Principal Chemist Method Development / Validation

DNA Oligonucleotides Functionalized with Thermolytic 4-Hydroxy-1-butyl or 4-Phosphato/thiophosphato-1-butyl thiophosphate Protecting Groups as Potential Prodrugs
Journal of Organic Chemistry, 2007

Contributing authors:
Jon S. Kauffman, Ph.D.
Director of Biopharmaceutical Services and
Analytical Method Development / Validation

John Snyder, Ph.D.
Principal Chemist Biopharmaceutical Services

Analytical Testing to Support Biopharmaceutical Products
The BioPharm International Guide, April 2007

Authors:
Jon S. Kauffman, Ph.D.
Director of Biopharmaceutical Services and
Analytical Method Development / Validation

Identification and Risk-Assessment of Extractables and Leachables
Pharmaceutical Technology Primer, January 2006

Author:
Jon S. Kauffman, Ph.D.
Director of Biopharmaceutical Services and
Analytical Method Development / Validation

Validating On-line TOC Analyzers for Real-Time Release
Pharmaceutical Manufacturing, November/December, 2006

Author:
Jon S. Kauffman, Ph.D.
Director of Biopharmaceutical Services and
Analytical Method Development / Validation

31P NMR Study of the Desulfurization of Oligonucleoside Phosphorothioates Effected by “Aged” Trichloroacetic Acid Solutions
Journal of Organic Chemistry, 2005

Contributing authors:
Jon S. Kauffman, Ph.D.
Director of Biopharmaceutical Services and
Analytical Method Development / Validation

John Snyder, Ph.D.
Principal Chemist Biopharmaceutical Services

Qualification and Validation of USP Apparatus 4
Dissolution Technologies, May 2005

Author:
Jon S. Kauffman, Ph.D.
Director of Biopharmaceutical Services and
Analytical Method Development / Validation