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PERSEPTIVE BIOSYSTEMS SUBMITS DRUG MASTER FILE WITH FDA COVERING POROS CHROMATOGRAPHY MEDIA

 PERSEPTIVE BIOSYSTEMS SUBMITS DRUG MASTER FILE WITH FDA
 COVERING POROS CHROMATOGRAPHY MEDIA
 CAMBRIDGE, Mass., June 25 /PRNewswire/ -- PerSeptive Biosystems, Inc. (NASDAQ: PBIO) announced today that it has submitted a Drug Master File with the U.S. Food & Drug Administration. The Drug Master File covers manufacturing and test protocols of the company's POROS(R) chromatographic materials for production scale biomolecule purification.
 The Drug Master File submission facilitates FDA regulatory filings by PerSeptive Biosystems' customers because they can incorporate POROS manufacturing information into their New Drug Applications (NDA) and Investigational New Drug (IND) requests by reference to the PerSeptive Drug Master File.
 Noubar B. Afeyan, Ph.D., president and CEO of the company, stated, "The filing of the Drug Master File represents another step for PerSeptive Biosystems in becoming an important supplier of high productivity purification products at manufacturing scale. We believe this filing will help support the adoption of our technologies, allowing biopharmaceutical manufacturers to accelerate product development, reduce manufacturing costs and increase quality controls for their products."
 The biopharmaceutical industry uses POROS chromatography media in the scale-up and manufacturing-scale purification of biomolecules, including proteins, peptides and oligonucleotides. POROS materials are used to perform the company's patented purification process called Perfusion Chromatography(R), and are used in reverse-phase, ion-exchange and other chromatography modes.
 PerSeptive Biosystems designs, manufactures and markets proprietary products and systems for the purification and analysis of biomolecules. These bioseparations products are designed to reduce significantly the time and cost required for the development and manufacture of biopharmaceuticals. The company's current and planned products for the purification and analysis of biomolecules are based on three interrelated core technologies: Perfusion Chromatography, ImmunoDetection(tm) and Rational Surface Design(tm).
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 Note: Perfusion Chromatography and POROS are registered trademarks and ImmunoDetection and Rational Surface Design are trademarks of the company.
 -0- 6/25/92
 /CONTACT: Robert A. Fein, vice president and chief financial officer of PerSeptive Biosystems, 617-621-1787/
 (PBIO) CO: PerSeptive Biosystems, Inc. ST: Massachusetts IN: MTC SU:


CN -- NE003 -- 3614 06/25/92 08:37 EDT
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Publication:PR Newswire
Date:Jun 25, 1992
Words:334
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