Buy Process Validation in Manufacturing of Biopharmaceuticals
Book 1
Book 2
Book 3
Book 1
Book 2
Book 3
Book 1
Book 2
Book 3
Book 1
Book 2
Book 3
Home > Mathematics and Science Textbooks > Biology, life sciences > Process Validation in Manufacturing of Biopharmaceuticals: Guidelines, Current Practices, and Industrial Case Studies
Process Validation in Manufacturing of Biopharmaceuticals: Guidelines, Current Practices, and Industrial Case Studies

Process Validation in Manufacturing of Biopharmaceuticals: Guidelines, Current Practices, and Industrial Case Studies


     0     
5
4
3
2
1



Out of Stock


Notify me when this book is in stock
X
About the Book

Written by experienced authorities in process validation, this reference explores current trends in the field, as well as strategies for the selection of the most appropriate quality control scheme-offering practical guidelines, recommendations, and an abundance of industrial case studies that showcase various techniques and approaches in the validation of biopharmaceutical processes.

Table of Contents:
Guidelines to Process Validation, G. Sofer Applications of Failure Modes and Effects Analysis to Biotechnology Manufacturing Processes, R.J. Seely and J. Haury Process Characterization, J.E. Seely Scale-Down Models for Purification Processes: Approaches and Applications, R. Godavarti, J. Petrone, J. Robinson, R. Wright, and B.D. Kelley Adventitious Agents: Concerns and Testing for Biopharmaceuticals, R. Nims, E. Presente, G. Sofer, C. Phillips, and A. Chang Life Span Studies for Chromatography and Filtration Media, A.S. Rathore and G. Sofer Validation of a Flitration Strap, J. Campbell Analytical Test Methods for Well-Characterized Biological and Biotechnological Products, N. Ritter and J. McEntire Facility Design Issues-A Regulatory Perspective, N. Roscioli and S. Vargo Validation of Computerized Systems, M.J. Cahilly Process Optimization and Characterization Studies for Purification of an E. coli-Expressed Protein Product, A.S. Rathore Validation of the ZEVALINÒ Purification Process - A Case Study, L. Conley, J. McPherson, and J. Thömmes Process Validation of a Multivalent Bacterial Vaccine: A Novel Matrix Approach, N.S. Pujar, M.G. Gayton, W.K. Herber, C. Abeygunawardana, M.L. Dekleva, P.K. Yegneswaran, and A.L. Lee Viral Clearance Validation: A Case Study, M. Rubino, M. Bailey, J. Baker, J.A. Boose, L. Metzka, V. Moore, M. Quertinmont, and W. Wiler about the editors... ANURAG S. RATHORE is a Scientist in Process Development, Amgen Inc., Thousand Oaks, California. His group is responsible for the support of process development, process characterization, scale-up, production, and process validation of late stage products. Before joining Amgen Inc., he held a similar position at Pharmacia Corporation. Dr. Rathore has authored more than 50 publications and presentations and is series editor of the Biotechnology and Bioprocessing series for Marcel Dekker. He is the editor of several recent books including Scale-up

Review :
an extremely timely release that should quickly become a primary reference tool in the pharmaceutical industry.


Best Sellers


Product Details
  • ISBN-13: 9781574445169
  • Publisher: Taylor & Francis Inc
  • Publisher Imprint: Informa Healthcare
  • Edition: New edition
  • Language: English
  • No of Pages: 600
  • Sub Title: Guidelines, Current Practices, and Industrial Case Studies
  • Width: 152 mm
  • ISBN-10: 1574445162
  • Publisher Date: 01 Mar 2005
  • Binding: Hardback
  • Height: 229 mm
  • No of Pages: 600
  • Returnable: N
  • Weight: 1019 gr


Similar Products

Add Photo
Add Photo

Customer Reviews

REVIEWS      0     
Click Here To Be The First to Review this Product
Process Validation in Manufacturing of Biopharmaceuticals: Guidelines, Current Practices, and Industrial Case Studies
Taylor & Francis Inc -
Process Validation in Manufacturing of Biopharmaceuticals: Guidelines, Current Practices, and Industrial Case Studies
Writing guidlines
We want to publish your review, so please:
  • keep your review on the product. Review's that defame author's character will be rejected.
  • Keep your review focused on the product.
  • Avoid writing about customer service. contact us instead if you have issue requiring immediate attention.
  • Refrain from mentioning competitors or the specific price you paid for the product.
  • Do not include any personally identifiable information, such as full names.

Process Validation in Manufacturing of Biopharmaceuticals: Guidelines, Current Practices, and Industrial Case Studies

Required fields are marked with *

Review Title*
Review
    Add Photo Add up to 6 photos
    Would you recommend this product to a friend?
    Tag this Book Read more
    Does your review contain spoilers?
    What type of reader best describes you?
    I agree to the terms & conditions
    You may receive emails regarding this submission. Any emails will include the ability to opt-out of future communications.

    CUSTOMER RATINGS AND REVIEWS AND QUESTIONS AND ANSWERS TERMS OF USE

    These Terms of Use govern your conduct associated with the Customer Ratings and Reviews and/or Questions and Answers service offered by Bookswagon (the "CRR Service").


    By submitting any content to Bookswagon, you guarantee that:
    • You are the sole author and owner of the intellectual property rights in the content;
    • All "moral rights" that you may have in such content have been voluntarily waived by you;
    • All content that you post is accurate;
    • You are at least 13 years old;
    • Use of the content you supply does not violate these Terms of Use and will not cause injury to any person or entity.
    You further agree that you may not submit any content:
    • That is known by you to be false, inaccurate or misleading;
    • That infringes any third party's copyright, patent, trademark, trade secret or other proprietary rights or rights of publicity or privacy;
    • That violates any law, statute, ordinance or regulation (including, but not limited to, those governing, consumer protection, unfair competition, anti-discrimination or false advertising);
    • That is, or may reasonably be considered to be, defamatory, libelous, hateful, racially or religiously biased or offensive, unlawfully threatening or unlawfully harassing to any individual, partnership or corporation;
    • For which you were compensated or granted any consideration by any unapproved third party;
    • That includes any information that references other websites, addresses, email addresses, contact information or phone numbers;
    • That contains any computer viruses, worms or other potentially damaging computer programs or files.
    You agree to indemnify and hold Bookswagon (and its officers, directors, agents, subsidiaries, joint ventures, employees and third-party service providers, including but not limited to Bazaarvoice, Inc.), harmless from all claims, demands, and damages (actual and consequential) of every kind and nature, known and unknown including reasonable attorneys' fees, arising out of a breach of your representations and warranties set forth above, or your violation of any law or the rights of a third party.


    For any content that you submit, you grant Bookswagon a perpetual, irrevocable, royalty-free, transferable right and license to use, copy, modify, delete in its entirety, adapt, publish, translate, create derivative works from and/or sell, transfer, and/or distribute such content and/or incorporate such content into any form, medium or technology throughout the world without compensation to you. Additionally,  Bookswagon may transfer or share any personal information that you submit with its third-party service providers, including but not limited to Bazaarvoice, Inc. in accordance with  Privacy Policy


    All content that you submit may be used at Bookswagon's sole discretion. Bookswagon reserves the right to change, condense, withhold publication, remove or delete any content on Bookswagon's website that Bookswagon deems, in its sole discretion, to violate the content guidelines or any other provision of these Terms of Use.  Bookswagon does not guarantee that you will have any recourse through Bookswagon to edit or delete any content you have submitted. Ratings and written comments are generally posted within two to four business days. However, Bookswagon reserves the right to remove or to refuse to post any submission to the extent authorized by law. You acknowledge that you, not Bookswagon, are responsible for the contents of your submission. None of the content that you submit shall be subject to any obligation of confidence on the part of Bookswagon, its agents, subsidiaries, affiliates, partners or third party service providers (including but not limited to Bazaarvoice, Inc.)and their respective directors, officers and employees.

    Accept


    Inspired by your browsing history


    Your review has been submitted!

    You've already reviewed this product!