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Protein Formulation and Delivery

Protein Formulation and Delivery

          
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This third edition retains the basic scientific principles associated with the previous editions but brings to light the latest challenges associated with preparing, characterizing, formulating and delivering the ever-increasing types of biopharmaceutical molecules into therapeutics. New chapters include biopharmaceutical structure and drug delivery, protein design and engineering, quality by design for biopharmaceuticals, manufacturing and purification of biopharmaceuticals, immune response triggers by route of administration, proteins in the solid state, the challenge of biosimilars, and transdermal delivery of protein therapeutics.


About the Author:

Eugene McNally, PhD, is executive director and head of PPD's Regulatory Consulting Group and is an expert in global chemistry, manufacturing and controls (CMC)

Dr. Jayne E. Hastedt is the CEO and co-founder of JDP Pharma Consulting, LLC, which provides CMC consulting services to the pharmaceutical, biotech, and drug device industries

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About the Book

This title is intended to assist pharmaceutical scientists in the development of stable protein formulations during the early stages of the product development process, providing a comprehensive review of mechanisms and causes of protein instability in formulation development, coverage of accelerated stability testing methods and relevant analytical methods, and an overview of the drug substance manufacturing process. Preformulation and the development of traditional solutions and lyophilized formulations frequently used for intravenous delivery and non-traditional formulations are also addressed. Because many developments in the field have emerged since the publication of the First Edition, this Second Edition addresses important new patient-friendly developments in the field, such as formulation for implantable devices, needle-free formulation and delivery approaches, and oral delivery of proteins.


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Product Details
  • ISBN-13: 9780849379499
  • Publisher: CRC Press
  • Publisher Imprint: Crc Press
  • Edition: 0002-
  • Language: English
  • Returnable: N
  • Spine Width: 22 mm
  • Width: 160 mm
  • ISBN-10: 0849379490
  • Publisher Date: 26 Oct 2007
  • Binding: Hardback
  • Height: 235 mm
  • No of Pages: 376
  • Series Title: Drugs and the Pharmaceutical Sciences
  • Weight: 599 gr


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