Lyophilization of Pharmaceuticals and Biologicals New Technologies and Approaches 1st edition by Kevin Ward, Paul Matejtschuk ISBN 1493989278 978-1493989270

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ISBN 10: 1493989278 
ISBN 13:  978-1493989270
Author:  Kevin Ward, Paul Matejtschuk

This detailed volume brings together leading practitioners in the freeze-drying community to address recent progress, not only in new analytical tools and applications of the data derived in cycle design but also in the manufacturing of lyophilized products in the healthcare sector – whether these be therapeutics, vaccines or diagnostic products – and indeed the equipment to deliver this scale of freeze-drying. Areas of focus include analytical and formulation issues, process monitoring and control, as well as post-lyophilization analysis. Written for the Methods in Pharmacology and Toxicology series, chapters include the type of expert advice that leads to superior results in the lab.
Authoritative and practical, Lyophilization of Pharmaceuticals and Biologicals: New Technologies and Approaches serves as an ideal guide for researchers working in or just seeking an update on this rapidly changing field.

Lyophilization of Pharmaceuticals and Biologicals: New Technologies and Approaches 1st Table of contents:

• Characterization of Formulations for Freeze Drying: This involves analyzing and understanding the formulation components before the lyophilization process to ensure stability and quality in the final product.
• Formulation and Process Development for Lyophilized Biological Reference Materials: This focuses on creating reliable and standardized formulations for biological materials that will be lyophilized, ensuring consistency and reproducibility.
• Controlled Ice Nucleation Using ControLyo® Pressurization-Depressurization Method: This technique helps manage the formation of ice during freeze-drying, crucial for optimizing the product’s structure and stability.
• Alternative Methods of Controlling Nucleation in Freeze Drying: Discusses various innovative techniques to control ice nucleation in the freeze-drying process, ensuring the product’s quality and functionality.
• Tunable Diode Laser Absorption Spectroscopy in Lyophilization: A tool used to monitor the lyophilization process in real-time, improving process control and ensuring product quality.
• Containment Options for the Freeze-Drying of Biological Entities and Potent Materials: Examines strategies for containing and protecting sensitive or potent biological substances during lyophilization.
• Freeze Drying Systems: Freeze Dryer Design Requirements & Automatic Loading and Unloading Systems (ALUS™): Details the technical specifications and automated systems used in freeze-drying equipment for efficient and controlled production.
• Regulatory Aspects of Freeze Drying: Addresses the regulatory framework surrounding freeze-drying in pharmaceutical and biologic product manufacturing to ensure compliance with standards and safety.
• Container and Reconstitution Systems for Lyophilized Drug Products: Discusses the types of containers and systems used to store and reconstitute lyophilized drugs for use, focusing on convenience, stability, and ease of use.
• Scale-Up of Freeze-Drying Cycles, the Use of Process Analytical Technology (PAT) and Statistical Analysis: Describes how freeze-drying processes are scaled up for industrial production and the role of process analytics and statistical tools in optimizing these processes.
• Through Vial Impedance Spectroscopy (TVIS): A Novel Approach to Process Understanding for Freeze-Drying Cycle Development: A new technique that uses impedance spectroscopy to monitor and understand the freeze-drying process, aiding in cycle optimization.
• Lyophilization of High-Concentration Protein Formulations: Focuses on the unique challenges and strategies for lyophilizing high-concentration protein formulations, which are sensitive to changes in process parameters.
• Mechanical Behavior and Structure of Freeze-Dried Cakes: Investigates the physical properties and structural integrity of the freeze-dried cakes, which are critical for product stability and shelf-life.
• High Resolution Mass Spectrometric Methods for Proteins in Lyophilized Solids: Describes the use of advanced mass spectrometry techniques to analyze proteins in lyophilized solids, helping to assess product quality and integrity.

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