000			01323nam a2200169Ia 4500
008			140223b2005 xxu||||| |||| 00| 0 eng d
020			_a9781574445169 _c0.00
082			_a615.152 _bPRO
245			_aProcess Validation in Manufacturing of Biophamaceuticals: Guidelines, Current Practices and Industrial Case Studies
260			_aBoca Raton _bTaylor & Francis _c2005
300			_a578p
500			_aWritten by top authorities in process validation, this reference explores current trends in the field and strategies for selecting the most appropriate quality control scheme. It offers practical guidelines, recommendations, and an abundance of case studies that showcase various techniques and approaches in the validation of biopharmaceutical processes. These include guidance on determining the life spans of chromatography and filtration media, process characterization and techniques for scaling-down unit operations in biopharmaceutical manufacturing, examples of contamination events, and practical methods for testing raw materials and in-process samples during various manufacturing stages.
700			_aRathore, Anurag Singh _eEditor _9104922
700			_aSofer, Gail _eEditor _9104923
942			_2ddc _cLB
995			_aPharmacy Reference _eP0001867 _j615.152 _yP0001867
999			_c16149 _d16149