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His area of work includes formulation, process development, QbD approaches, process validation for late stage vaccine and monoclonal antibody biotech products. Parag Kolhe, Ph.D., is People Leader-Senior Principal Scientist at Pfizer in the department of Biotherapeutic Pharmaceutical Sciences in Chesterfield, MO. 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. 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.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.Formulation approaches that discuss a variety of dosage forms including protein therapeutics, lipid-based controlled delivery systems, PEGylated biotherapeutics, nasal dosage form, and vaccines.Key concepts relevant to the successful development of sterile products are illustrated through case studies and are covered under three sections in this book:
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This comprehensive book encompasses various facets of sterile product development.