Formulation and Process Development Strategies for Manufacturing Biopharmaceuticals
Home > Science, Technology & Agriculture > Industrial chemistry and manufacturing technologies > Industrial chemistry and chemical engineering > Pharmaceutical chemistry and technology > Formulation and Process Development Strategies for Manufacturing Biopharmaceuticals
Formulation and Process Development Strategies for Manufacturing Biopharmaceuticals

Formulation and Process Development Strategies for Manufacturing Biopharmaceuticals


     0     
5
4
3
2
1



Available


X
About the Book

A real-world guide to the production and manufacturing of biopharmaceuticals While much has been written about the science of biopharmaceuticals, there is a need for practical, up-to-date information on key issues at all stages of developing and manufacturing commercially viable biopharmaceutical drug products. This book helps fill the gap in the field, examining all areas of biopharmaceuticals manufacturing, from development and formulation to production and packaging. Written by a group of experts from industry and academia, the book focuses on real-world methods for maintaining product integrity throughout the commercialization process, clearly explaining the fundamentals and essential pathways for all development stages. Coverage includes: Research and early development phase?appropriate approaches for ensuring product stability Development of commercially viable formulations for liquid and lyophilized dosage forms Optimal storage, packaging, and shipping methods Case studies relating to therapeutic monoclonal antibodies, recombinant proteins, and plasma fractions Useful analysis of successful and failed products Formulation and Process Development Strategies for Manufacturing Biopharma-ceuticals is an essential resource for scientists and engineers in the pharmaceutical and biotech industries, for government and regulatory agencies, and for anyone with an interest in the latest developments in the field.

Table of Contents:
Introduction (John Carpenter). Part I Preformulation and Development of Stability Indicating Assays: Biophysical Characterization Techniques. 1. The Structure of Biological Therapeutics (Sherry Martin-Moe, Y. John Wang, Tim Osslund, Tahir Mahmood, Rohini Deshpande, and Susan Hershenson). 2. Chemical Instability in Peptide and Protein Pharmaceuticals (Elizabeth M. Topp, Lei Zhang, Hong Zhao, Robert W. Payne, Gabriel J. Evans and Mark Cornell Manning). 3. Physical Instability in Peptide and Protein Pharmaceuticals (Byeong Chang and Bernice Yang). 4. Immunogenicity of Therapeutic Proteins (Steven J Swanson). 5. Preformulation Research: Assessing Protein Solution Behavior Early During Therapeutic Development (Bernardo Perez-Ramirez, Nicholas Guziewicz and Robert Simler). 6. Formulation Development of Phase I/II Biopharmaceuticals: An Efficient and Timely Approach (Nicholas W. Warne). 7. Late Stage Formulation Development and Characterization of Biopharmaceuticals (Adeolla O Grillo). 8. An Empirical Phase Diagram/ High Throughput Screening Approach to the Characterization and Formulation of Biopharmaceuticals (Sangeeta B. Joshi; Akhilesh Bhambhani; Yuhong Zeng; and C. Russell Middaugh). 9. Fluorescence and Phosphorescence Methods to Probe Protein Structure and Stability in Ice: the Case of Azurin (Giovanni Strambini). 10. Applications of Sedimentation Velocity Analytical Ultracentrifugation (Tom Laue). 11. Field Flow Fractionation with Multi-angle Light Scattering for Measuring Particle Size of Virus-like Particles (Joyce A Sweeney and Christopher Hamm). 12. Light Scattering Techniques and their Application to Formulation and Aggregation Concerns (Philip Wyatt and Michael Larkin). Part 2 Development of a Formulation for Liquid Dosage Form. 13. Efficient Approaches to Formulation Development of Biopharmaceuticals (Rajiv Nayar and Mitra Mosharraf). 14. Prediction of Protein Aggregation Propensities from Primary Sequence Information (Mark Cornell Manning, Gabriel J. Evans, Cody M. Van Pelt and Robert W. Payne). 15. High Concentration Antibody Formulations (Steven J. Shire, Jun Liu, Wolfgang Friess, Susanne Matheus and Hanns-Christian Mahler). 16. Development of Formulations for Therapeutic Monoclonal Antibodies and Fc Fusion Proteins (Sampath kumar Krishnan, Monica M. Pallitto and Margaret S. Ricci). 17. Reversible Self-Association of Pharmaceutical Proteins: Characterization and Case Studies (Vikas K. Sharma, Harminder Bajaj and Devendra S. Kalonia). Part 3 Development of Formulation for Lyophilized Dosage Form. 18. Design of a Formulation for Freeze Drying (Feroz Jameel and Mike J. Pikal). 19. Protein Conformation and Reactivity in Amorphous Solids (Lei Zhang, Sandipan Sinha and Elizabeth M. Topp). 20. The Impact of Buffer on Solid-State Properties and Stability of Freeze-Dried Dosage Forms (Evgenyi Y. Shalaev and Larry A. Gatlin). 21. Stabilization of Lyophilized Pharmaceuticals by Control of Molecular Mobility: Impact of Thermal History (Suman Luthra and Micheal J. Pikal). 22. Structural Analysis of Proteins in Dried Matrices (Andrea Hawe, Sandipan Sinha, Wolfgang Friess and Wim Jiskoot). 23. The Impact of Formulation and Drying Processes on the Characteristics and Performance of Biopharmaceutical Powders (Vu L. Truong and Ahmad M. Abdul-Fattah). Part 4 Manufacturing Sciences. 24. Manufacturing Fundamentals for Biopharmaceuticals (Maninder Hora). 25. Protein Stability during Bioprocessing (Mark Cornell Manning, Gabriel J. Evans and Robert W. Payne). 26. Freezing and Thawing of Protein Solutions (Satish Singh and Sandeep Neema). 27. Strategies for Bulk Storage and Shipment of Proteins (Feroz Jameel, Chakradhar Padala and Theodore W. Randolph). 28. Drying Process Methods for Biopharmaceutical Products: An Overview (Ahmad M. Abdul-Fattah and Vu L. Truong). 29. Spray Drying of Biopharmaceuticals and Vaccines (Jim Searles and Govindan (Dan) Mohan). 30. Development and Optimization of Freeze Drying Process (Feroz Jameel and Jim Searles). 31. Considerations for Successful Lyophilization Process Scale-up, Technology Transfer and Routine Production (Samir Sane and Chung C. Hsu). 32. Process Robustness in Freeze-Drying of Biopharmaceuticals (D.Q. Wang, D. MacLean and X. Ma). 33. Filling Processes and Technologies for Liquid Biopharmaceuticals (Ananth Sethuraman, Xiaogang Pan, Bhavya Mehta and Vinay Radhakrishnan). 34. Leachables and Extractables (Jim Castner, Pedro Benites and Michael Bresnick). 35. Primary Container/Closure Selection for Biopharmaceuticals (Olivia Henderson). 36. Pre-filled Syringes for Biopharmaceuticals (Robert Swift and Robin Hwang). 37. Impact of Manufacturing Processes on the Drug Product Stability and Quality (Nitin Rathore, Rahul S. Rajan and Erwin Freund). Index.

About the Author :
Feroz jameel, PhD, is Principal Scientist for Drug Product Process Development at Amgen, involved in the development of biopharmaceutical products and the develop-ment of new technologies to enhance drug product manufacturing. Dr. Jameel is the recipient of the Parenteral Drug Association's 1999 Fred Simon Award for the Best Paper Published in the PDA Journal of Pharmaceutical Science and Technology. SUSAN HERSHENSON, PhD, is Vice President for Pharmaceutical and Device Development at Genentech. She has more than fifteen years' experience in the area of formulation and delivery, including development of protein and small molecule therapeutics.

Review :
"This book is intended as a comprehensive look at the growing area of producing and manufacturing biopharmaceuticals, right the way through from development to commercialisation. Each chapter is written by an expert in that area and authors hail from both industry and academia." (TCE- The Chemical Engineer, 1 December 2010)


Best Sellers


Product Details
  • ISBN-13: 9780470118122
  • Publisher: John Wiley & Sons Inc
  • Publisher Imprint: John Wiley & Sons Inc
  • Height: 239 mm
  • No of Pages: 984
  • Returnable: N
  • Weight: 1406 gr
  • ISBN-10: 0470118121
  • Publisher Date: 10 Sep 2010
  • Binding: Hardback
  • Language: English
  • Returnable: N
  • Spine Width: 58 mm
  • Width: 163 mm


Similar Products

Add Photo
Add Photo

Customer Reviews

REVIEWS      0     
Click Here To Be The First to Review this Product
Formulation and Process Development Strategies for Manufacturing Biopharmaceuticals
John Wiley & Sons Inc -
Formulation and Process Development Strategies for Manufacturing Biopharmaceuticals
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.

Formulation and Process Development Strategies for Manufacturing Biopharmaceuticals

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

    New Arrivals


    Inspired by your browsing history


    Your review has been submitted!

    You've already reviewed this product!