000 04593nam a22004815i 4500
001 978-1-4614-7978-9
003 DE-He213
005 20140220082831.0
007 cr nn 008mamaa
008 131012s2013 xxu| s |||| 0|eng d
020 _a9781461479789
_9978-1-4614-7978-9
024 7 _a10.1007/978-1-4614-7978-9
_2doi
050 4 _aRS380
050 4 _aRS190-210
072 7 _aTDCW
_2bicssc
072 7 _aMED072000
_2bisacsh
082 0 4 _a615.19
_223
100 1 _aKolhe, Parag.
_eeditor.
245 1 0 _aSterile Product Development
_h[electronic resource] :
_bFormulation, Process, Quality and Regulatory Considerations /
_cedited by Parag Kolhe, Mrinal Shah, Nitin Rathore.
264 1 _aNew York, NY :
_bSpringer New York :
_bImprint: Springer,
_c2013.
300 _aXVI, 585 p. 89 illus., 67 illus. in color.
_bonline resource.
336 _atext
_btxt
_2rdacontent
337 _acomputer
_bc
_2rdamedia
338 _aonline resource
_bcr
_2rdacarrier
347 _atext file
_bPDF
_2rda
490 1 _aAAPS Advances in the Pharmaceutical Sciences Series,
_x2210-7371 ;
_v6
505 0 _aBasic Principles of Sterile Product Formulation Development -- Molecule and Manufacturability Assessment Leading to Robust Commercial Formulation for Therapeutic Proteins -- Polymer and Lipid Based Systems for Parenteral Drug Delivery -- Formulation Approaches and Strategies for PEGylated Biotherapeutics -- Nasal Delivery -- Formulation Approaches and Strategies for Vaccines and Adjuvants -- Challenges in Freeze-Thaw Processing of Bulk Protein Solutions -- Best Practices for Technology Transfer of Sterile Products: Case Studies -- Transfer Across Barrier Systems: A New Source of Simplification in Aseptic Fill and Finish Operations -- Challenges and Innovation in Aseptic Filling: Case Study with the Closed Vial Technology -- Contemporary Approaches to Development and Manufacturing of Lyophilized Parenterals -- Advances in Container Closure Integrity Testing -- Pen and Autoinjector Drug Delivery Devices -- Particulate Matter in Sterile Parenteral Products -- Appearance Evaluation of Parenteral Pharmaceutical Products -- Sterile Filtration Principles, Best Practices and New Developments -- Intravenous Admixture Compatibility for Sterile Products: Challenges and Regulatory Guidance -- Basics of Sterilization Methods -- Avoiding Common Errors during Viable Microbial Contamination Investigations -- Validation of Rapid Microbiology Methods (RMMs) -- Validation of Moist and Dry Heat Sterilization.
520 _aThis comprehensive book encompasses various facets of sterile product development. Key concepts relevant to the successful development of sterile products are illustrated through case studies and are covered under three sections in this book: • Formulation approaches that discuss a variety of dosage forms including protein therapeutics, lipid-based controlled delivery systems, PEGylated biotherapeutics, nasal dosage form, and vaccines • Process, container closure and delivery considerations including freeze-thaw process challenges, best practices for technology transfer to enable commercial product development, innovations and advancement in aseptic fill-finish operations, approaches to manufacturing lyophilized parenteral products, pen / auto-injector delivery devices, and associated container closure integrity testing hurdles for sterile product closures • Regulatory and quality aspects in the areas of particulate matter and appearance evaluation, sterile filtration, admixture compatibility considerations, sterilization process considerations, microbial contamination investigations and validation of rapid microbiological methods, and dry and moist heat sterilizers This book is a useful resource to scientists and researchers in both industry and academia, and it gives process and product development engineers insight into current industry practices and evolving regulatory expectations for sterile product development.
650 0 _aMedicine.
650 0 _aPharmaceutical technology.
650 1 4 _aBiomedicine.
650 2 4 _aPharmaceutical Sciences/Technology.
650 2 4 _aBiomedicine general.
700 1 _aShah, Mrinal.
_eeditor.
700 1 _aRathore, Nitin.
_eeditor.
710 2 _aSpringerLink (Online service)
773 0 _tSpringer eBooks
776 0 8 _iPrinted edition:
_z9781461479772
830 0 _aAAPS Advances in the Pharmaceutical Sciences Series,
_x2210-7371 ;
_v6
856 4 0 _uhttp://dx.doi.org/10.1007/978-1-4614-7978-9
912 _aZDB-2-SBL
999 _c96014
_d96014