This book addresses key concepts and applications in sterile product development. Throughout, it illustrates key concepts relevant to the successful development of sterile products with the help of case studies.

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.

Addresses the key concepts and applications in sterile product area Illustrates fundamental understanding as well as practical implications in sterile product development life cycle Broad range of in-depth information on numerous topics Includes supplementary material: sn.pub/extras

Autorentext

Parag Kolhe, Ph.D., is People Leader-Senior Principal Scientist at Pfizer in the department of Biotherapeutic Pharmaceutical Sciences in Chesterfield, MO. His area of work includes formulation, process development, QbD approaches, process validation for late stage vaccine and monoclonal antibody biotech products. He is the author of various peer reviewed publications and patent applications in the area of polymeric drug delivery system and biotherapeutic product development. He received his Ph.D. from Wayne State University in the area of Material Science and Engineering.

Mrinal Shah, Ph.D., is a Senior Process Development Engineer within the R&D group at LifeCell Corporation in Bridgewater, NJ where his focus and expertise lies in process design, scale-up, validation and technology transfer for tissue and medical device products. His research experience and interest spans tissue regenerative medication and parenteral and ophthalmic product development. Dr. Shah has authored several peer reviewed publications in the field of phase separation and aggregation in protein solution systems. He received his Ph.D. degree in Chemical & Biomolecular Engineering from the University of Houston and has also been awarded postdoctoral fellowships at Houston Advance Research Center and the Center for Biotechnology and Interdisciplinary Studies, Rensselaer Polytechnic Institute. Nitin Rathore, Ph.D, is a Principal Scientist in Drug Product Process Development at Amgen Inc., Thousand Oaks, California. His group is involved with the development of liquid and lyophilized protein drug products. Dr. Rathore has expertise in the area of formulation, fill & finish and drug delivery including process characterization, scale-up and technology transfer of early to late stage biopharmaceuticals. He has authored numerous publications including original research articles, book chapters and scientific presentations on drug productdevelopment. Dr. Rathore received his Ph.D. degree in chemical and biological engineering from University of Wisconsin-Madison, Madison, WI.

Inhalt

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.