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Quality Assurance for Biopharmaceuticals
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Quality Assurance for Biopharmaceuticals Hardcover - 1994 - 1st Edition

by Jean F. Huxsoll


From the publisher

This volume provides basic guidelines concerning quality assurance and its responsibilities for biopharmaceuticals manufactured by either recombinant, monoclonal antibody or other biotechnological methodologies. The author discusses what systems are needed, and gives a detailed description of each system and its functions. Leading authorities in the biotechnology industry offer insight and suggestions in order to assure the safety, purity and efficacy of the products produced.

From the rear cover

Dr. Jean Huxsoll and a team of distinguished biotechnology industry experts from the U.S. and Europe offer a wealth of practical guidelines to designing, implementing, and managing QA systems to assure that biopharmaceutical products meet standards for safety purity, and potency. Quality Assurance for Biopharmaceuticals covers all important theoretical and practical concerns, including detailed guidelines to meeting GMP compliance; quality assurance of production; quality assurance of analytical methods; advanced documentation, sampling, and validation techniques; comprehensive coverage of regulatory issues in the U.S., Europe, and Japan; and much more.

Details

  • Title Quality Assurance for Biopharmaceuticals
  • Author Jean F. Huxsoll
  • Binding Hardcover
  • Edition number 1st
  • Edition 1
  • Pages 216
  • Volumes 1
  • Language ENG
  • Publisher Wiley-Interscience
  • Date 1994-06-22
  • ISBN 9780471036562 / 0471036560
  • Weight 1.1 lbs (0.50 kg)
  • Dimensions 9.6 x 6.47 x 0.77 in (24.38 x 16.43 x 1.96 cm)
  • Library of Congress subjects Pharmaceutical biotechnology - Quality
  • Library of Congress Catalog Number 93046160
  • Dewey Decimal Code 615.19

About the author

Jean F. Huxsoll is the author of Quality Assurance for Biopharmaceuticals, published by Wiley.

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Quality Assurance for Biopharmaceuticals
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Quality Assurance for Biopharmaceuticals

by Huxsoll, Jean F.

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