Sterile Product Development Formulation, Process, Quality and Regulatory Considerations /
This 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...
Saved in:
| Corporate Author: | |
|---|---|
| Other Authors: | , , |
| Format: | Electronic eBook |
| Language: | English |
| Published: |
New York, NY :
Springer New York : Imprint: Springer,
2013.
|
| Edition: | 1st ed. 2013. |
| Series: | AAPS Advances in the Pharmaceutical Sciences Series,
6 |
| Subjects: | |
| Online Access: | https://doi.org/10.1007/978-1-4614-7978-9 |
| Tags: |
Add Tag
No Tags, Be the first to tag this record!
|
| LEADER | 05094nam a22005295i 4500 | ||
|---|---|---|---|
| 001 | 978-1-4614-7978-9 | ||
| 003 | DE-He213 | ||
| 005 | 20200701052909.0 | ||
| 007 | cr nn 008mamaa | ||
| 008 | 131012s2013 xxu| s |||| 0|eng d | ||
| 020 | |a 9781461479789 |9 978-1-4614-7978-9 | ||
| 024 | 7 | |a 10.1007/978-1-4614-7978-9 |2 doi | |
| 050 | 4 | |a RS380 | |
| 050 | 4 | |a RS190-210 | |
| 072 | 7 | |a TDCW |2 bicssc | |
| 072 | 7 | |a MED072000 |2 bisacsh | |
| 072 | 7 | |a TDC |2 thema | |
| 082 | 0 | 4 | |a 615.19 |2 23 |
| 245 | 1 | 0 | |a Sterile Product Development |h [electronic resource] : |b Formulation, Process, Quality and Regulatory Considerations / |c edited by Parag Kolhe, Mrinal Shah, Nitin Rathore. |
| 250 | |a 1st ed. 2013. | ||
| 264 | 1 | |a New York, NY : |b Springer New York : |b Imprint: Springer, |c 2013. | |
| 300 | |a XVI, 585 p. 89 illus., 67 illus. in color. |b online resource. | ||
| 336 | |a text |b txt |2 rdacontent | ||
| 337 | |a computer |b c |2 rdamedia | ||
| 338 | |a online resource |b cr |2 rdacarrier | ||
| 347 | |a text file |b PDF |2 rda | ||
| 490 | 1 | |a AAPS Advances in the Pharmaceutical Sciences Series, |x 2210-7371 ; |v 6 | |
| 505 | 0 | |a Basic 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 | |a This 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 | |a Pharmaceutical technology. | |
| 650 | 0 | |a Medicine. | |
| 650 | 1 | 4 | |a Pharmaceutical Sciences/Technology. |0 https://scigraph.springernature.com/ontologies/product-market-codes/B21010 |
| 650 | 2 | 4 | |a Biomedicine, general. |0 https://scigraph.springernature.com/ontologies/product-market-codes/B0000X |
| 700 | 1 | |a Kolhe, Parag. |e editor. |4 edt |4 http://id.loc.gov/vocabulary/relators/edt | |
| 700 | 1 | |a Shah, Mrinal. |e editor. |4 edt |4 http://id.loc.gov/vocabulary/relators/edt | |
| 700 | 1 | |a Rathore, Nitin. |e editor. |4 edt |4 http://id.loc.gov/vocabulary/relators/edt | |
| 710 | 2 | |a SpringerLink (Online service) | |
| 773 | 0 | |t Springer Nature eBook | |
| 776 | 0 | 8 | |i Printed edition: |z 9781461479796 |
| 776 | 0 | 8 | |i Printed edition: |z 9781461479772 |
| 776 | 0 | 8 | |i Printed edition: |z 9781493952052 |
| 830 | 0 | |a AAPS Advances in the Pharmaceutical Sciences Series, |x 2210-7371 ; |v 6 | |
| 856 | 4 | 0 | |u https://doi.org/10.1007/978-1-4614-7978-9 |
| 912 | |a ZDB-2-SBL | ||
| 912 | |a ZDB-2-SXB | ||
| 950 | |a Biomedical and Life Sciences (SpringerNature-11642) | ||
| 950 | |a Biomedical and Life Sciences (R0) (SpringerNature-43708) | ||