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Tuesday, May 19, 2020 | History

5 edition of Biological product freeze-drying and formulation found in the catalog.

Biological product freeze-drying and formulation

proceedings of a Symposium organized by the Center for Biologics Evaluation and Research of the United States Public Health Service Food and Drug Administration and the International Association of Biological Standardization held at the Jack Masur Auditorium of the Warren Grant Magnuson Clinical Center of the National Institutes of Health, Bethesda, Maryland, USA, 24-26 October, 1990 ; acting editors, Joan C. May, F. Brown.

by International Symposium on Biological Product Freeze-Drying and Formulation (1990 Bethedsa, Md.)

  • 225 Want to read
  • 33 Currently reading

Published by Karger in Basel, New York .
Written in English

    Subjects:
  • Freeze-drying -- Congresses.,
  • Biological products -- Congresses.

  • Edition Notes

    Includes bibliographical references.

    SeriesDevelopments in biological standardization -- v. 74.
    ContributionsMay, Joan C., Brown, F., International Association of Biological Standardization.
    Classifications
    LC ClassificationsQH324.9.C7 I58 1990
    The Physical Object
    Paginationx, 377 p. :
    Number of Pages377
    ID Numbers
    Open LibraryOL18004802M
    ISBN 103805554664

    The book concludes with selected case studies and discusses the future of freeze-drying, advances in alternative drying methods, and concludes with an extensive bibliography. This book, written by a leading expert in the field, is aimed primarily at product . Definitely, it is a great textbook for a scientist to start thinking lyophilization. However, the only way to improve is get into lyophlization cycle development plus lyo product manufacturing 5/5.

      Pharmaceutical Technology Europe. When freeze drying biological materials, the major concern is achieving product consistency both within a batch and between batches. Consistency is judged over a number of parameters, such as: physical appearance. composition. Freeze-drying, or lyophilization, is a well established technology used in the preservation of numerous pharmaceutical and biological products. This highly effective dehydration method involves the removal .

    Freeze-drying, or lyophilization, is a well established technology used in the preservation of numerous pharmaceutical and biological products. This highly effective dehydration method involves the Price: $   Abstract. Freeze-drying has become one of the most important processes for the preservation of biological products. This chapter provides protocols for freeze-drying of proteins and discusses the importance of formulation Cited by:


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Biological product freeze-drying and formulation by International Symposium on Biological Product Freeze-Drying and Formulation (1990 Bethedsa, Md.) Download PDF EPUB FB2

Freeze-drying, or lyophilization, is a well established technology used in the preservation of numerous pharmaceutical and biological products. This highly effective dehydration method involves the removal of water from frozen materials 5/5(1).

It delineates the best execution of steps from closure preparation and regulatory control of products to equipment sterilization and process validation. With 13 new chapters providing state-of-the-art information, the book unveils innovations currently advancing the field, including LYOGUARD ® packaging for bulk freeze-drying and the irradiation of pharmaceutical and biological products.5/5(1).

Book Description Freeze-drying, or lyophilization, is a well established technology used in the preservation of numerous pharmaceutical and biological products. This highly effective dehydration method involves the removal of water from frozen materials.

International Symposium on. BIOLOGICAL PRODUCT FREEZE-DRYING AND FORMULATION. Proceedings of a Symposium organized by the Center for Biologies Evaluation and Research of the United States Public Health Service Food and Drug Administration and the International Association of Biological Standardization File Size: KB.

Freeze-drying, or lyophilization, is a well established technology used in the preservation of numerous pharmaceutical and biological by: International Symposium on Biological Product Freeze-Drying and Formulation: proceedings of a symposium Author: Center for Biologics Evaluation Biological product freeze-drying and formulation book Research (U.S.) ; International Association of Biological Standardization.

Lyophilization of Biopharmaceuticals. Humans have been experimenting with lyophilization, or freeze-drying, as a method to preserve biological structures for over a thousand years.

This comprehensive volume, intended for scientists in both academia and industry, covers a wide range of topics relevant to the formulation of peptide and protein drugs in the freeze-dried state.1/5(1). moisture contents in freeze-drying S.L. Nail and J.W. Johnson (West Lafayette and Kalamazoo): Methodology for in-process determination of residual water in freeze-dried products Joan C.

May, R.M. Wheeler, sso(Bethesda): Measurementoffinal container residual moisture in freeze-dried biological products.

Freeze drying, or lyophilization, is a well established technology used in the preservation of numerous pharmaceutical and biological products. This highly effective dehydration method involves.

Biological Drug Products begins with general considerations for the development of any biological drug product and then explores the strategies and challenges involved in the development of specific types of biologics.

Divided into five parts, the book /5(2). An example of at least one pharmaceutical product on the market that has utilized an organic cosolvent system during freeze-drying is CAVERJECT1. Sterile Powder (2,3).

This particular product has been Cited by: 9. Research Articles Lyophilization of protein formulations in vials: Investigation of the relationship between resistance to vapor flow during primary drying and small†scale product collapse David E. Cited by:   Freeze-drying, or lyophilization, is a well established technology used in the preservation of numerous pharmaceutical and biological products.

This highly effective dehydration method. INTRODUCTION Although freeze-drying is the process of choice for improving the shelf life of biological products such as proteins, the process itself and the subsequent longterm storage generate several Cited by: 2.

Abstract. One of the most wide-reaching changes in freeze-drying over the past 20 years has been the commercial availability of a range of discriminating analytical methods to identify critical temperatures in formulations Cited by: 3.

Biological Product Freeze-Drying and Formulation: Symposium Organized by the Center for Biologics Evaluation and Research, Bethesda, October (Developments in Biological Standardization S.). Freeze-Drying Lyophilization Of Pharmaceutical & Biological Products, Third Edition (Drugs and the Pharmaceutical Sciences, ) Louis Rey, Joan C.

May Freeze drying, or lyophilization, is a well established technology used in the preservation of numerous pharmaceutical and biological products.

The goal of the freeze-drying or lyophilisation is to withdraw the water from the product and thus chemical reactions (hydrolysis, rearrangements, oxidations, and especially proteins and peptides. Highlights the application of freeze-drying to pharmaceuticals, illustrating practical and industry-tested methods of preserving and reactivating delicate biologicals and biochemicals.

The text discusses the basic principles and engineering aspects of lyophilization, and also the role of bulking agents, cryoprotectants, antioxidants, free radicals, and other products. Freeze drying is mainly used to remove the water f rom sensitive products, mostly of biological ori gin, without damaging them, so they can be preserved easily, in a permanently.

Results from differential thermal analysis/impedance and freeze drying microscopy determinations, signifies that the freezing step product temperature must be well below °, while throughout.INTRODUCTION Historically, many freeze-drying cycles have been arrived at on an empirical basis, and while some of these cycles may produce consistently acceptable products, in recent years it has become more widely accepted that cycles should be developed on a more rational and scientific basis with an understanding of the formulation .This detailed volume brings together leading practitioners in the freeze-drying community to address recent progress, not only in new analytical tools and applications of the data derived in cycle design but also in the manufacturing of lyophilized products in the healthcare sector – whether these be therapeutics, vaccines or diagnostic products .