Biopharmaceutical Published Articles

Key Aspects of Enzyme Activity and Steady-State Kinetics
BioProcess International, September 2011

Author:
Robert J. Duff, Ph.D., Manager, Biopharmaceutical Services

Is there a trend towards specialization or diversification amongst contract service providers? Are sponsors looking for a "one-stop shop" for all their needs?
Pharmaceutical Processing, August 2011

Contributing author:
Michael McDowell, Director, Business Development

Why should a company outsource its research and development?
Pharmaceutical Processing, August 2011

Contributing author:
Michael McDowell, Director, Business Development

Predicting Virus Filtration Performance with Virus Spike Characterization
BioProcess International, March 2011

Contributing author:
Katherine F. Bergmann, Ph.D., Manager of Viral Safety and Viral Clearance Services

Perspectives on Method Validation II: Validation is a multistep process with USP regulatory guidelines at each step
Pharmaceutical Formulation Quality, February/March 2010

Heather Bridwell, Group Leader/Chemist, Analytical Method Development / Validation
Jennifer Roark, Group Leader/Chemist, Analytical Method Development / Validation
Thomas Lehman, Ph.D., Manager of Analytical Method Development / Validation

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

Heather Bridwell, Group Leader/Chemist, Analytical Method Development / Validation
Vikas Dhingra, Ph.D., Group Leader, Biochemistry
Daniel Peckman, Ph.D. - Group Leader, Biochemistry
Jennifer Roark, Group Leader/Chemist, Analytical Method Development / Validation
Thomas Lehman, Ph.D., Manager of Analytical Method Development / Validation

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

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

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: Timothy Oostdyk, Ph.D., Executive Vice President and 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

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

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

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