Articles by Herb Lutz - BioPharm International

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Articles by Herb Lutz

Considerations for Scaling-up Depth Filtration of Harvested Cell Culture Fluid

Data on the performance and variability of different formats.
Mar 1, 2009

Data on the performance and variability of different formats.

Introduction to Validation of Biopharmaceuticals

Mar 1, 2005

Synthetic drugs can be well characterized by established analytical methods. Biologics on the other hand are complex, high-molecular-weight products, and analytical methods have limited abilities to completely characterize them and their impurity profiles. Regulation of biologics includes not only final product characterization but also characterization and controls on raw materials and the manufacturing process.

Viral Filtration of Plasma-Derived Human IgG: A Case Study Using Viresolve NFP

Nov 1, 2004

Human plasma provides a rich source of therapeutic medicines, including gamma globulins, coagulation factors, albumin, alpha anti-trypsin, and others. In 2001, sales of immuno gamma-globulin (IgG) were estimated at $2 billion with a production rate of 50 metric tons for the year.1 A number of new therapeutic products have recently been introduced including Gammimune from Bayer, RhoPhylac from ZLB Behring, and Octagam from Octapharma.

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