Publications

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