Publication Archive

ACombating SARS-CoV-2: leveraging microbicidal experiences with other emerging/re-emerging viruses

Raymond W. Nims (contributing author)

Process Analytical Technologies and Data Analytics for the Manufacture of Monoclonal Antibodies

Scott Rudge (co-author)

Assessing the Contributions of Inactivation, Removal, and Transfer of Ebola Virus and Vesicular Stomatitis Virus by Disinfectant Pre-soaked Wipes

Raymond W. Nims (contributing author)

Thermal Inactivation of Feline Calicivirus and Herpes Simplex Virus Type 1: Side-by-Side Suspension and Carrier Studies

Raymond W. Nims (contributing author)

Advances in BiochemicalEngineering/Biotechnology 171- Current Applications of Pharmaceutical Biotechnology

Scott Rudge (contributing author)

Cell Lines as Biological Models: Practical Steps for More Reliable Research

Capes-Davis, et al (Raymond W. Nims contributing author)

ICH Quality Guidelines: An Implementation Guide

Raymond W. Nims (Editor), Andrew Teasdale (Editor), David Elder (Editor)

Best practices for the use and evaluation of animal serum as a component of cell culture medium

Nims RW, Harbell JW

Single-use Systems for Biotechnology Products

Scott Rudge

Quality Risk Management

Scott Rudge

Applications for Transitions and Moment Analysis

Korben Knudson and Scott Rudge

Inactivation and Disinfection of Zika Virus on a Nonporous Surface

Cameron Wilde, Zheng Chen, Tanya Kapes, Cory Chiossone, Salimatu Lukula, Donna Suchmann, Raymond Nims, and S Steve Zhou

Research finds Zika virus can live for hours on hard, non-porous surfaces

Raymond W. Nims, S. Steve Zhou

Intra-family differences in efficacy of inactivation of small, non-enveloped viruses

Raymond W. Nims, S. Steve Zhou

Bioseparations Science and Engineering: 2nd Edition

Scott R. Rudge, Paul W. Todd, Demetri Petrides, Roger G. Harrison

Gamma Irradiation of Animal Serum: Validation of Efficacy for Pathogen Reduction and Assessment of Impacts on Serum Performance

Mark Plavsic, PhD, DVM, Raymond Nims, PhD, Marc Wintgens, and Rosemary J. Versteegen, PhD

Modeling the Efficacy of HTST for Inactivating Mouse Minute Virus

Plavsic, M. and Nims, R. W.

Contractor responsibilities in outsourced pharmaceutical quality control testing

Nims, R. W., and Meyers, E.

Overview of the nonclinical quality and toxicology testing for recombinant biopharmaceuticals produced in mammalian cells

Lebrec, H., Narayanan, P., and Nims, R.

USP <63> Mycoplasma Tests: A new regulation for mycoplasma testing

Nims, R. W., and Meyers, E.

Adventitious viruses detected in biopharmaceutical bulk harvest samples over a 10-year period

Kerr, A., and Nims, R.

Gamma-irradiation of serum for the inactivation of adventitious contaminants

Gauvin, G., and Nims, R.

Short tandem repeat profiling: part of an overall strategy for reducing the frequency of cell misidentification

Nims, R. W., Sykes, G., Cottrill, K., Ikonomi, P., and Elmore, E.

Authentication of human cell-based products: the role of a new consensus standard

Kerrigan, L., and Nims, R. W.

Non-tuberculosis mycobacterium contamination of a mammalian cell bioreactor process for biologics manufacture

Nims, R., Chun, A., Marino, A., and Dieringer-Boyer, S.

Adventitious viral contamination of biopharmaceuticals: Who is at risk?

Nims, R.

Gamma irradiation of animal sera for inactivation of viruses and mollicutes – a review

Nims, R. W., Gauvin, G., and Plavsic, M.

Circovirus inactivation – A literature review

Nims, R. W., and Plavsic, M.

Contractee Responsibilities in Outsourced Pharmaceutical Quality Control Testing

Raymond Nims and Elizabeth Meyers

Compliance Master PlansAre You Traveling Without One?

Timothy Joy, Scott Rudge, and Joanne Izyk

Controlled Environments
Multi-tenant Facilities for Biotech and Pharmaceutical Companies: Proactive landlords and developers savvy to life science concepts will attract tenants and share success. (Part I and Part II)
—Scott R. Rudge, Timothy G. Joy and Vicki Jenings

Sterilization
Steam Say Clean with Steam: Effective when saturated, steam is efficient and inexpensive, relative to other sterilization unit operations
—Scott Rudge