@article{727213,
      recid = {727213},
      author = {Varshney, Dushyant, and Manmohan Singh,},
      title = {Lyophilized biologics and vaccines modality-based  approaches / [electronic resource] :},
      pages = {1 online resource (xi, 401 pages) :},
      note = {Includes index.},
      abstract = {This book provides a detailed account of the most recent  developments, challenges and solutions to seamlessly  advance and launch lyophilized biologics or vaccine  products, based on diverse modalities, ranging from  antibodies (e.g., monoclonal, fusion), complex biologics  (e.g., antibody drug conjugates, PEGylated proteins) and  vaccines (e.g., recombinant protein based). The authors  adeptly guide you through everything you need to know, from  biophysical and chemical stability considerations of  proteins, to critical assessment during process scale-up,  technology transfer, packaging, alternate drying and device  selection for a successful process validation, regulatory  submission and launch of a stable, safe and effective  product. Lyophilized Biologics and Vaccines: Modality-Based  Approaches serves as a reference to all critical  assessments and steps from early pre-formulation stages to  product launch: Provides recent understanding of  heterogeneity of protein environment in frozen systems,  buffer stabilization, instrumental analysis and controlled  ice nucleation technology Details product development  strategies based on diverse modalities of biologics and  vaccines, including plasmid DNA and lipid-based  therapeutics Recent updates on quality-by-design and  process analytical technology approaches, illustrated by  case studies and FDA perspective Provides the latest  account of alternate drying technologies including spray  drying and bulk freeze-drying Chapters are written by one  or more world-renowned leading authorities from academia,  industry or regulatory agencies, whose expertise cover  lyophilization of the diverse modalities of  biopharmaceuticals. Their contributions are based on the  exhaustive review of literature coupled with excellent  hands-on experiences in laboratory or GMP setup, making  this an exceptional guide to all stages of lyophilized or  dehydrated product development and commercial  manufacturing. Dushyant B. Varshney, Ph.D., has made  significant contributions in manufacturing science and  technology, due diligence, tech transfer, product and  process development (including lyophilization),  quality-by-design and process analytical technologies for  biologics, vaccines and small molecules. He is currently a  Director of Manufacturing Assessment, MS&T at Hospira Inc.  Manmohan Singh, Ph.D., is a well-known expert in the area  of vaccine formulations and adjuvant research and has been  working in vaccine R&D for the last 20 years. He is  currently the Head of Global Drug Product Development at  Novartis Vaccines and Diagnostics in Holly Springs, NC.},
      url = {http://library.usi.edu/record/727213},
}