@article{890457,
      recid = {890457},
      author = {Geigert, J.},
      title = {The challenge of CMC regulatory compliance for  biopharmaceuticals /},
      pages = {1 online resource},
      abstract = {This book since first published in 2004 has been a major  resource providing insights and practical guidance for the  CMC teams to develop an acceptable cost-effective,  risk-based CMC regulatory compliance strategy for  biopharmaceuticals (recombinant proteins, monoclonal  antibodies, genetically engineered viruses and genetically  engineered human cells) from early clinical stage  development through market approval. The third edition of  this book provides added coverage for the biosimilars,  antibody drug conjugates (ADCs), bispecific antibodies,  genetically engineered viruses, and genetically engineered  cells. This third edition of the book also addresses the  heightened pressure on CMC regulatory compliance timelines  due to the introduction of expedited clinical pathways  moving the clinical development closer to a seamless phase  process (e.g., FDA Breakthrough Therapy designation, CBER  Regenerative Medicine Advanced Therapy (RMAT) designation,  EMA Priority Medicines (PRIME) designation). The Challenge  of CMC Regulatory Compliance for Biopharmaceuticals is  essential, practical information for all pharmaceutical  development scientists, Manufacturing and Quality Unit  staff, Regulatory Affairs personnel, and senior management  involved in the manufacture of biopharmaceuticals.},
      url = {http://library.usi.edu/record/890457},
}