rdf-syntax-grammar
mods:
  schema location: http://www.loc.gov/mods/v3 http://www.loc.gov/standards/mods/v3/mods-3-2.xsd
  title info:
    non sort: The
    title: Challenge of CMC Regulatory Compliance for Biopharmaceuticals and Other Biologics
  name:
    name part: Geigert, John.
    role:
      role term: creator
    role:
      role term: author.
  name:
    name part: SpringerLink (Online service)
  type of resource: text
  origin info:
    place:
      place term: xxu
    date issued: 2013
    edition: 2nd ed. 2013.
    issuance: monographic
  language:
    language term: eng
  physical description:
    form: electronic
    form: electronic resource
    reformatting quality: access
    form: remote
    extent: XXIX, 338 p. 24 illus., 17 illus. in color. online resource.
  abstract: An effective CMC regulatory compliance strategy for biologics and biopharmaceuticals can seem like a mystery. Through means of this 2nd edition, this no longer needs to occur. A great deal of thanks goes to two regulatory authorities – the United States Food and Drug Administration (FDA) and the European Medicines Agency (EMA), who provide through their respective websites, an abundance of guidance, especially in the last several years. So much has changed since the 1st edition of this book was published in 2004. There are now additional manufacturing processes for producing commercial biopharmaceuticals – transgenic plant cell cultures and transgenic animals. In addition to commercial recombinant proteins and monoclonal antibodies, there are now commercial cell-based medicines (cellular therapy) and DNA-based medicines (gene therapy). Biosimilars are now on the marketplace in Europe, and under review for commercial approval in the USA. Vaccine manufacturing has resurged due to the concerns of potentially pandemic mutated animal influenzas (e.g., swine flu, bird flu). Strategic international regulatory guidances have been adopted that are driving the entire pharmaceutical industry, including biopharmaceuticals, to a higher standard of performance, including Quality by Design (QbD), Quality Risk Management (QRM) and Pharmaceutical Quality Systems (PQS). The vast majority of the over 600 regulatory references listed in this book were either issued or updated since the release of the 1st edition. All of these changes are the reason this updated edition includes not only biopharmaceuticals but also other biologics (e.g., live virus vaccines, human plasma-derived proteins, cell-based medicines, natural-sourced proteins) that have CMC regulatory compliance concerns and challenges in common with the genetically-engineered biologics (i.e., the biopharmaceuticals). About The Author John Geigert is President of BioPharmaceutical Quality Solutions, which specializes in providi…
  table of contents: Complexity of Biologica CMC Regulation -- Biologics are Not Chemical Drugs -- An Effective CMC Strategy is Possible -- Challenge of Adventitious Agent Control -- Source Materials for Biologics -- Manufacture of the Biologic API -- The Biologic Final Product Process -- Complex Process-Related Impurities -- Molecular Structural Analysis -- Functional Activity (Potency) -- Setting Specifications and Expiry Dates -- Demonstrating Product Comparability -- CMC-Focused Regulatory Meetings -- References.
  note: by John Geigert.
  subject:
    topic: Medicine
  subject:
    topic: Pharmaceutical technology
  subject:
    topic: Biomedicine
  subject:
    topic: Pharmaceutical Sciences/Technology
  subject:
    topic: Biomedicine general
  classification: RS380
  classification: RS190-210
  classification: 615.19
  related item:
    title info:
      title: Springer eBooks
  identifier: 9781461469162
  identifier: http://dx.doi.org/10.1007/978-1-4614-6916-2
  record info:
    record creation date: 130507
    record change date: 20130727075522.0
    record identifier: 978-1-4614-6916-2