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Formulation And Process Development Strategies For Manufacturing Biopharmaceuticals

comprehensively covers fundamentals and essential pathways for each production phase; as well as the purpose, function, and relation to other stages;

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ChitosanBased Systems for Biopharmaceuticals

. Chitosan-Based Systems for Biopharmaceuticals provides an extensive overview of the application of chitosan and its derivatives in the development;

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Process Validation in Manufacturing of Biopharmaceuticals

in the field and strategies for the selection of the most appropriate quality control scheme. It offers practical guidelines, recommendations;

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Delivery Technologies for Biopharmaceuticals

of value to researchers and students working in drug delivery, formulation, biopharmaceuticals, medicinal chemistry, and new materials development.;

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High-Throughput Formulation Development of Biopharmaceuticals

High Throughput Formulation Development of Biopharmaceuticals: Practical Guide to Methods and Applications provides the latest;

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The Challenge of CMC Regulatory Compliance for Biopharmaceuticals

is essential, practical information for all pharmaceutical development scientists, Manufacturing and Quality Unit staff, Regulatory Affairs personnel;

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Pharmaceutical Preformulation and Formulation

molecules to the growth of biopharmaceuticals. The book meets the need for advanced information for drug preformulation and formulation and;

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Biopharmaceutical Production Technology

- Advances in Process Development - Analytical Technologies - Quality Control - Process Design and Management - Changing Face of Processing With;

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Biopharmaceuticals

of biopharmaceuticals; and the future scope of biopharmaceutical industry development. This book is the latest resource for a wide circle of scientists;

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Drug Delivery Nanoparticles Formulation and Characterization

development for various therapeutic applications and provides advanced methods used to file for regulatory approval. This comprehensive guide;

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Pharmaceutical Quality by Design

, analytical development, formulation development, dissolution testing, manufacturing, stability studies, bioequivalence testing, risk and assessment;

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Development of Biopharmaceutical Parenteral Dosage Forms

, strategies to reduce/eliminate adsorption, and specialized containers for biotechnological applications and more! Furnished with helpful;

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Strategies for Formulations Development

Strategies for Formulations Development: A Step-by-Step Guide Using JMP(R) is based on the authors significant practical experience;

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Protein Formulation and Delivery

and the development of traditional solutions and lyophilized formulations frequently used for intravenous delivery and non-traditional;

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Sterile Drug Products

Sterile Drug Products: Formulation, Packaging, Manufacturing, and Quality teaches the basic principles of the development and manufacture;

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Process Validation in Manufacturing of Biopharmaceuticals

validation. It includes discussion on the final version of the FDA 2011 Guidance for Industry on Process Validation Principles and Practices;

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Modern Biopharmaceuticals

, limiting their scope to those procedures and developments with proven potential for the biotechnology industry. They cover all relevant aspects;

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PAT Applied in Biopharmaceutical Process Development and Manufacturing

developed, there is a great need for flexible and proactive teams in order to satisfy the regulatory requirements during process development;

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Detection and Quantification of Antibodies to Biopharmaceuticals

strategies, choice of appropriate assay end-points, and data analysis for the detection and quantification of neutralizing antibodies to;

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Quality by Design for Biopharmaceuticals

management, and the application of QbD. Complete with real-world case studies, this is a core reference for scientists in the biopharmaceutical;

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Therapeutic Protein Drug Products

laboratory formulation sections focus on the most common buffers, excipients, and Ph ranges that are commonly tested in addition to systematic;

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Preclinical Safety Evaluation of Biopharmaceuticals

The goal is to provide a comprehensive reference book for the preclinicaldiscovery and development scientist whose responsibilities span;

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Methodology for the Development of National IP Strategies Toolkit - Tool 1

A methodology handbook describing the various stages of the national lP strategy formulation process, providing advice on how to involve;

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SingleUse Technology in Biopharmaceutical Manufacture

advances in the field of single-use technology and explores topics including applying single-use devices for microorganisms, human mesenchymal stem;

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Plasmid Biopharmaceuticals

characteristics of plasmids provides the basics for designing plasmid products (applications) and processes (manufacturing). Key features that the authors;

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Perfusion Cell Culture Processes for Biopharmaceuticals

design and operation of continuous bioreactors, with emphasis on mammalian cell cultures for producing therapeutic proteins. Topics include the;

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The Challenge of CMC Regulatory Compliance for Biopharmaceuticals

the strategic importance and value generated by QA/QC for their involvement in control of manufacturing. It will put into perspective the need;

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