Price loading...

Process Validation in Manufacturing of Biopharmaceuticals (Biotechnology and Bioprocessing)

9780367697624

General Medical Issues

Price data last checked 104 day(s) ago - refreshing...

View at Amazon

Price History & Forecast

No Price Data Available

Price history will appear here once data is collected from Amazon.

Price Distribution

No price data available for histogram

Description

The fourth edition of Process Validation in Manufacturing of Biopharmaceuticals is a practical and comprehensive resource illustrating the different approaches for successful validation of biopharmaceutical processes. A pivotal text in its field, this new edition provides guidelines and current practices, contains industrial case studies, and is expanded to include in-depth analysis of the new Process Validation (PV) guidance from the US FDA. Key Features: Offers readers a thorough understanding of the key concepts that form the basis of a good process validation program for biopharmaceuticals. Includes case studies from the various industry leaders that demonstrate application of these concepts. Discusses the use of modern tools such as multivariate analysis for facilitating a process validation exercise. Covers process characterization techniques for scaling down unit operations in biopharmaceutical manufacturing, including chromatography, chemical modification reactions, ultrafiltration, and microfiltration, and practical methods to test raw materials and in-process samples. Providing a thorough understanding of the key concepts that form the basis of a good process validation program, this book will help readers ensure that PV is carried out and exceeds expectations. Fully illustrated, this is a much-needed practical guide for biopharmaceutical manufacturers.

Product Specifications

Model: 9780367697624
Format: hardcover
ASIN: 0367697629
Category: Books > Subjects > Health, Family & Lifestyle > Medical & Healthcare Practitioners > General Medical Issues
Domain: Amazon UK
Release Date: 18 December 2023
Listed Since: 09 June 2023

Barcode

No barcode data available

Process Validation in Manufacturing of Biopharmaceuticals (Biotechnology and Bioprocessing)

Price History & Forecast

No Price Data Available

Price Distribution

Description

Product Specifications

Barcode

Similar Products You Might Like

Handbook of Validation in Pharmaceutical Processes, Fourth Edition

Handbook of Validation in Pharmaceutical Processes, Fourth Edition

Filtration and Purification in the Biopharmaceutical Industry, Third Edition (Drugs and the Pharmaceutical Sciences)

Cleaning Validation Manual: A Comprehensive Guide for the Pharmaceutical and Biotechnology Industries

Filtration and Purification in the Biopharmaceutical Industry, Third Edition (Drugs and the Pharmaceutical Sciences)

Process Scale Bioseparations for the Biopharmaceutical Industry: 31 (Biotechnology and Bioprocessing)

PAT Applied in Biopharmaceutical Process Development And Manufacturing: An Enabling Tool for Quality-by-Design (Biotechnology and Bioprocessing)

Formulation and Process Development Strategies for Manufacturing Biopharmaceuticals

Biopharmaceuticals: Challenges and Opportunities

Biotechnology: Quality Assurance and Validation (Drug Manufacturing Technology Series)

Development of Biopharmaceutical Parenteral Dosage Forms: 085 (Drugs and the Pharmaceutical Sciences)

Handbook of Analytical Validation

Handbook of Analytical Validation

Advanced Technologies in Biopharmaceutical Processing

MASTERING CLEANING VALIDATION: ENSURING COMPLIANCE AND EXCELLENCE IN PHARMACEUTICAL MANUFACTURING

Pharmaceutical Equipment Validation: The Ultimate Qualification Guidebook

Validating Chromatographic Methods: A Practical Guide

Fermentation Microbiology and Biotechnology, Fourth Edition

CRC Press - How to Sell Validatable Equipment to Pharma

Sterile Filtration: A Practical Approach

Parenteral Medications, Fourth Edition

Biopharmaceutical Processing: Development, Design, and Implementation of Manufacturing Processes

Pharmaceutical Process Scale-Up (Drugs and the Pharmaceutical Sciences)

Basics of Pharmaceutical Manufacturing and Quality Operations: A Comprehensive Guide