ATLANTA--(BUSINESS WIRE)--Jan. 26, 2004--Gradipore Limited and Serologicals Corporation (NASDAQ: SERO - News) today announced the successful scale up of a process used to purify hyperimmune IgG from source plasma using Gradipore's patented Gradiflow technology.
Gradipore developed a Gradiflow application, initially on an analytical scale using the BF-400 unit. As a second stage Gradipore replicated this separation using the GF-100, which is a GMP compliant production scale unit. Using the GF-100 Gradipore fractionated commercial quantities of plasma, representing a 500 fold increase in scale. The process is being developed hand in hand with a Drug Master File (DMF) for Gradiflow technology.
The scale up process culminated in a rigorous examination of the Gradipore facilities and the Gradiflow process carried out by senior scientific staff from Serologicals. Gradiflow was demonstrated to be scalable, robust and capable of reproducibly producing the same commercial production results time after time.
Gradipore Managing Director and CEO Dr Hari Nair said, "We are delighted with the outcome of the scale up as this represents an important part of Gradipore's development program. This project demonstrates that the Gradiflow technology is a truly scalable production platform and is an attractive alternative to existing technologies in a commercial setting especially for niche plasma applications."
David Dodd, CEO of Serologicals said, "We are very pleased with the successful outcome of this program and believe it demonstrates the Gradiflow technology to be scalable and relevant to the production of important therapeutic products. We look forward to continued collaboration with Gradipore in the future."
Gradipore (ASX Code: GDP) is an Australian global biotechnology company which researches, develops, manufactures and markets hematological and separation technologies principally for the life science market throughout the world.
For information on Gradipore, visit the company's corporate web site at www.gradipore.com.
Serologicals Corporation, headquartered in Atlanta, Georgia, is a global provider of biological products and enabling technologies, which are essential for the research, development and manufacturing of biologically based life science products. The Company's products and technologies are used in a wide variety of innovative applications within the areas of oncology, hematology, immunology, cardiology and infectious diseases, as well as in the study of molecular biology. Serologicals has more than 650 employees worldwide, and its stock is traded on the Nasdaq National Stock Market under the symbol SERO.
Serologicals Corporation, Atlanta Bill Davis, 800-842-9099 or 678-728-2018 or Gradipore Limited Dr Hari Nair, 02 8977-9000 or John Manusu, 02 8977-9000
Source: Serologicals Corporation