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John A. Bontempo - Development of biopharmaceutical parenteral dosage forms

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This up-to-the-minute reference delineates-in a systematic fashion-the appropriate, sequential steps for the formulation of safe, effective, stable, and marketable liquid parenteral biopharmaceutical products-covering fundamentals and essential pathways for each phase as well as its purpose, function, and relation to other stages in the product development process. Written by experts currently involved in state-of-the-art advances in the pharmaceutical drug industry, Development of Biopharmaceutical Parenteral Dosage Forms details biopharmaceuticals that are licensed or undergoing clinical development, including genetically engineered cell and engineered vectors in the fermentation process describes purification and characterization techniques for rDNA therapeutics, discussing several types of unit operations for isolation, purification, and characterization considers preformulation and formulation requirements, such as physicochemical properties, drug delivery, stability studies programs, deactivation/denaturation routes, selection of compatible excipients, and regulatory compliance elucidates basics of analytical techniques, methods development, separation methods using chromatographic and electrophoretic techniques, and bioactivity methods covering bioassays and immunoassays for quantifying the stability of biological activity shows how to select the appropriate filter for maximizing compatibility and minimizing adsorption and inactivation, examining topics from basic filtration theories to future trends reviews the selection process for compatible elastomeric closures, analyzing physical, chemical, toxicological properties, protein adsorption on elastomeric surfaces, strategies to reduce/eliminate adsorption, and specialized containers for biotechnological applications and more! Furnished with helpful references, tables, and drawings, this practical guide is indispensable for pharmaceutical, medicinal, and protein chemists; molecular biologists; process engineers; purification scientists; biopharmaceutical and pharmaceutical formulators and product developers; quality control, quality assurance, and regulatory compliance personnel; and upper-level undergraduate and graduate students in these disciplines.

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title Development of Biopharmaceutical Parenteral Dosage Forms Drugs and - photo 1


title:Development of Biopharmaceutical Parenteral Dosage Forms Drugs and the Pharmaceutical Sciences ; V. 85
author:Bontempo, John A.
publisher:Informa Healthcare
isbn10 | asin:082479981X
print isbn13:9780824799816
ebook isbn13:9780585378008
language:English
subjectPharmaceutical biotechnology, Parenteral solutions.
publication date:1997
lcc:RS380.D48 1997eb
ddc:615/.6
subject:Pharmaceutical biotechnology, Parenteral solutions.

Page a

Development of Biopharmaceutical Parenteral Dosage Forms

Page b

DRUGS AND THE PHARMACEUTICAL SCIENCES

Executive Editor
James Swarbrick
AAI, Inc.
Wilmington, North Carolina

Advisory Board
Larry L. Augsburger
University of Maryland
Baltimore, Maryland
David E. Nichols
Purdue University
West Lafayette, Indiana
Douwe D. Breimer
Gorlaeus Laboratories
Leiden, The Netherlands
Stephen G. Schulman
University of Florida
Gainesville, Florida
Trevor M. Jones
The Association of the
British Pharmaceutical Industry
London, United Kingdom
Jerome P. Skelly
Copley Pharmaceutical, Inc.
Canton, Massachusetts
Hans E. Junginger
Leiden/Amsterdam Center
for Drug Research
Leiden, The Netherlands
Felix Theeuwes
Alza Corporation
Palo Alto, California
Vincent H. L. Lee
University of Southern California
Los Angeles, California
Geoffrey T. Tucker
University of Sheffield
Royal Hallamshire Hospital
Sheffield, United Kingdom
Peter G. Welling
Institut de Recherche Jouveinal
Fresnes, France

Page c

DRUGS AND THE PHARMACEUTICAL SCIENCES

A Series of Textbooks and Monographs

  1. Pharmacokinetics, Milo Gibaldi and Donald Perrier
  2. Good Manufacturing Practices for Pharmaceuticals: A Plan for Total Quality Control, Sidney H. Willig, Murray M. Tuckerman, and William S. Hitchings IV
  3. Microencapsulation, edited by J. R. Nixon
  4. Drug Metabolism: Chemical and Biochemical Aspects, Bernard Testa and Peter Jenner
  5. New Drugs: Discovery and Development, edited by Alan A. Rubin
  6. Sustained and Controlled Release Drug Delivery Systems, edited by Joseph R. Robinson
  7. Modern Pharmaceutics, edited by Gilbert S. Banker and Christopher T. Rhodes
  8. Prescription Drugs in Short Supply: Case Histories, Michael A. Schwartz
  9. Activated Charcoal: Antidotal and Other Medical Uses, David O. Cooney
  10. Concepts in Drug Metabolism (in two parts), edited by Peter Jenner and Bernard Testa
  11. Pharmaceutical Analysis: Modern Methods (in two parts), edited by James W. Munson
  12. Techniques of Solubilization of Drugs, edited by Samuel H. Yalkowsky
  13. Orphan Drugs, edited by Fred E. Karch
  14. Novel Drug Delivery Systems: Fundamentals, Developmental Concepts, Biomedical Assessments, Yie W. Chien
  15. Pharmacokinetics: Second Edition, Revised and Expanded, Milo Gibaldi and Donald Perrier
  16. Good Manufacturing Practices for Pharmaceuticals: A Plan for Total Quality Control, Second Edition, Revised and Expanded, Sidney H. Willig, Murray M. Tuckerman, and William S. Hitchings IV
  17. Formulation of Veterinary Dosage Forms, edited by Jack Blodinger
  18. Dermatological Formulations: Percutaneous Absorption, Brian W. Barry
  19. The Clinical Research Process in the Pharmaceutical Industry, edited by Gary M. Matoren
  20. Microencapsulation and Related Drug Processes, Patrick B. Deasy
  21. Drugs and Nutrients: The Interactive Effects, edited by Daphne A. Roe and T. Colin Campbell

Page d

  1. Biotechnology of Industrial Antibiotics, Erick J. Vandamme
  2. Pharmaceutical Process Validation, edited by Bernard T. Loftus and Robert A. Nash
  3. Anticancer and Interferon Agents: Synthesis and Properties, edited by Raphael M. Ottenbrite and George B. Butler
  4. Pharmaceutical Statistics: Practical and Clinical Applications, Sanford Bolton
  5. Drug Dynamics for Analytical, Clinical, and Biological Chemists, Benjamin J. Gudzinowicz, Burrows T. Younkin, Jr., and Michael J. Gudzinowicz
  6. Modern Analysis of Antibiotics, edited by Adjoran Aszalos
  7. Solubility and Related Properties, Kenneth C. James
  8. Controlled Drug Delivery: Fundamentals and Applications, Second Edition, Revised and Expanded, edited by Joseph R. Robinson and Vincent H. Lee
  9. New Drug Approval Process: Clinical and Regulatory Management, edited by Richard A. Guarino
  10. Transdermal Controlled Systemic Medications, edited by Yie W. Chien
  11. Drug Delivery Devices: Fundamentals and Applications, edited by Praveen Tyle
  12. Pharmacokinetics: Regulatory Industrial Academic Perspectives, edited by Peter G. Welling and Francis L. S. Tse
  13. Clinical Drug Trials and Tribulations, edited by Allen E. Cato
  14. Transdermal Drug Delivery: Developmental Issues and Research Initiatives, edited by Jonathan Hadgraft and Richard H. Guy
  15. Aqueous Polymeric Coatings for Pharmaceutical Dosage Forms, edited by James W. McGinity
  16. Pharmaceutical Pelletization Technology, edited by Isaac Ghebre-Sellassie
  17. Good Laboratory Practice Regulations, edited by Allen F. Hirsch
  18. Nasal Systemic Drug Delivery, Yie W. Chien, Kenneth S. E. Su, and Shyi-Feu Chang
  19. Modern Pharmaceutics: Second Edition, Revised and Expanded, edited by Gilbert S. Banker and Christopher T. Rhodes
  20. Specialized Drug Delivery Systems: Manufacturing and Production Technology, edited by Praveen Tyle
  21. Topical Drug Delivery Formulations, edited by David W. Osborne and Anton H. Amann
  22. Drug Stability: Principles and Practices, Jens T. Carstensen
  23. Pharmaceutical Statistics: Practical and Clinical Applications, Second Edition, Revised and Expanded, Sanford Bolton
  24. Biodegradable Polymers as Drug Delivery Systems, edited by Mark Chasin and Robert Langer
  25. Preclinical Drug Disposition: A Laboratory Handbook, Francis L. S. Tse and James J. Jaffe

Page e

  1. HPLC in the Pharmaceutical Industry, edited by Godwin W. Fong and Stanley K. Lam
  2. Pharmaceutical Bioequivalence, edited by Peter G. Welling, Francis L. S. Tse, and Shrikant V. Dinghe
  3. Pharmaceutical Dissolution Testing, Umesh V. Banakar
  4. Novel Drug Delivery Systems: Second Edition, Revised and Expanded, Yie W. Chien
  5. Managing the Clinical Drug Development Process, David M. Cocchetto and Ronald V. Nardi
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