Main description:

The Handbook of Pharmaceutical Manufacturing Formulations, Third Edition: Volume Six, Sterile Products is an authoritative and practical guide to the art and science of formulating drugs for commercial manufacturing. With thoroughly revised and expanded content, this sixth volume of a six-volume set, compiles data from FDA and EMA new drug applications, patents and patent applications, and other sources of generic and proprietary formulations including author's own experience, to cover the broad spectrum of cGMP formulations and issues in using these formulations in a commercial setting. A must-have collection for pharmaceutical manufacturers, educational institutions, and regulatory authorities, this is an excellent platform for drug companies to benchmark their products and for generic companies to formulate drugs coming off patent.

Features:

Largest source of authoritative and practical formulations, cGMP compliance guidance and self-audit suggestions

Differs from other publications on formulation science in that it focuses on readily scalable commercial formulations that can be adopted for cGMP manufacturing

Tackles common difficulties in formulating drugs and presents details on stability testing, bioequivalence testing, and full compliance with drug product safety elements

Written by a well-recognized authority on drug and dosage form development including biological drugs and alternative medicines

Contents:

Part I Regulatory and Manufacturing

Chapter 1. Sterile Manufacturing Formulations Template

Chapter 2. Inspection of Sterile Product Manufacturing Facilities

Chapter 3. New Drug Application for Sterilized Products

Chapter 4. Validation of Cleaning Process

Chapter 5. Viral Safety Evaluation of Biotechnology Products Derived from Cell Lines of Human or Animal Origin

Chapter 6. Analysis of the Expression Construct in Cells Used for Production of rDNA-Derived Protein Products

Chapter 7. Stability Testing of Biotechnological/Biological Products

Chapter 8. Derivation and Characterization of Cell Substrates Used for Production of Biotechnological/Biological Products

Chapter 9. Comparability of Biotechnological/Biological Products Subject to Changes in Their Manufacturing Process

Chapter 10. Specifications: Test Procedures and Acceptance Criteria for Biotechnological/Biological Products

Chapter 11. Essential Clean-Room Design Elements

PartII Manufacturing Formulations

Sterile Product Formulations

Part III Commercial Pharmaceutical Formulations

Commercial Pharmaceutical Formulations

Index