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Research and Markets: Process Validation in Manufacturing of Biopharmaceuticals - Presents Process Characterization Techniques for Scaling down Unit Operations in Biopharmaceutical Manufacturing.

DUBLIN -- Dublin - Research and Markets ( has announced the addition of the "Process Validation in Manufacturing of Biopharmaceuticals, Third Edition" book to their offering.

Process Validation in Manufacturing of Biopharmaceuticals, Third Edition delves into the key aspects and current practices of process validation. It includes discussion on the final version of the FDA 2011 Guidance for Industry on Process Validation Principles and Practices, commonly referred to as the Process Validation Guidance or PVG, issued in final form on January 24, 2011. The book also provides guidelines and current practices, as well as industrial case studies illustrating the different approaches that can be taken for successful validation of biopharmaceutical processes.

Case Studies Include:

- Process validation for membrane chromatography

- Leveraging multivariate analysis tools to qualify scale-down models

- A matrix approach for process validation of a multivalent bacterial vaccine

- Purification validation for a therapeutic monoclonal antibody expressed and secreted by Chinese Hamster Ovary (CHO) cells

- Viral clearance validation studies for a product produced in a human cell line

A much-needed resource, this book presents process characterization techniques for scaling down unit operations in biopharmaceutical manufacturing, including chromatography, chemical modification reactions, ultrafiltration, and microfiltration. It also provides practical methods to test raw materials and in-process samples. Stressing the importance of taking a risk-based approach towards computerized system compliance, this book will help you and your team ascertain process validation is carried out and exceeds expectations.

Key Topics Covered:

Guidelines to Process Validation

Commentary on the US Food and Drug Administration's 2011 "Guidance for Industry, Process Validation General Principles and Practices"

Applications of Failure Modes and Effects Analysis to Biotechnology Manufacturing Processes

Process Characterization

Scale-Down Models for Purification Processes: Approaches and Applications

Adventitious Agents: Concerns and Testing for Biopharmaceuticals

Lifespan Studies for Chromatography and Filtration Media

Validation of a Filtration Step

Analytical Test Methods for Well-Characterized Biological and Biotechnological Products

Facility Design Issues: A Regulatory Perspective

Validation of Computerized Systems

Process Validation with a CMO

Risk Management & Validation

Process Validation in Membrane Chromatography

Leveraging Multivariate Analysis Tools to Qualify Scaled-Down Models

Process Validation of a Multivalent Bacterial Vaccine: A Novel Matrix Approach

Validation of the Zevalin? Purification Process: A Case Study

Viral Clearance Validation: A Case Study

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Publication:Business Wire
Date:Apr 11, 2012
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