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A Practical Guide to Biopharmaceutical Manufacturing

Published by: Informa Healthcare

Published: Dec. 1, 2006 - 234 Pages


Table of Contents


CHAPTER 1 THE PRODUCT LIABILITY HEADACHE: WHY IT’S WORSE FOR MEDICAL PRODUCTS
1.1 The cost of torts
1.2 What’s Unique About Medical Products
1.3 Risky products and vulnerable customers
1.4 High expectations
1.5 The industries’ image problem
1.6 The Possibility of Criminal Liability
1.7 The Double Whammy
1.8 Today’s Tort Targets
1.9 The Learned Intermediary Doctrine
1.10 Clinical Trials
CHAPTER 2 A CASE STUDY: WHAT INDUSTRY CAN LEARN FROM THE VIOXX EPISODE
2.1 The impact on Merck & Co
2.2 The impact on the industry
2.3 The Science Behind the Drug
2.4 Success and suspicions
2.5 Reaction to the recall
2.6 The lesson: Heed the auguries
2.6.1 Notice hints in the data
2.6.2 Gather more data
2.6.3 Don’t oversell
CHAPTER 3 GLOBAL CONCEPTS OF LIABILITY: UNIFORM GOALS, DIVERSE METHODS
3.1 Expanding liability
3.2 Common law and civil law
3.3 Finding a middle way
3.4 Implementing the middle way
3.5 National autonomy
3.5.1 Germany
3.5.2 Spain
3.5.3 England
CHAPTER 4 DRUG AND DEVICE PRODUCT LIABILITY IN THE US
4.1 Why US litigation processes matter
4.2 The Foundation Cases
4.3 The legal devices that help claimants
4.3.1 Discovery
4.3.2 Contingent Fees
4.3.3 Class actions
4.3.4 Punitive Damages
4.4 A big complication: 50 sets of rules
4.4.1 California’s all-share-liability doctrine
4.4.2 Michigan’s unique pharma suit limit
4.5 The standards for tort cases
4.6 Congressional relief for manufacturers
CHAPTER 5 WHAT MANUFACTURERS CAN DO TO MINIMISE EXPOSURE
5.1 Improving industry image and lowering expectations
5.2 Resisting speeding products to market
5.3 Handling recalls properly
5.4 Labelling and warnings
5.5 Vetting advertising and promotion more carefully
5.6 Clear and comprehensive records policies
5.7 Ensuring financial protection
CHAPTER 6 WHAT THE FUTURE MAY HOLD
6.1 Upswing in prescribing: Adverse interactions multiply
6.2 The impact of advances in genetics
6.2.1 Tailoring therapy to patients
6.2.2 Improving clinical trial design
6.2.3 Protection against privacy violation suits
6.3 Better understanding of mechanisms of action
6.4 The impact of direct-to-consumer promotion
6.5 Closer US-EU cooperation
6.6 Europe’s new emphasis on managing risk
6.7 The speed of drug approvals
6.8 New FDA training priorities
6.9 FDA efforts to pre-empt state law claims
6.10 Congressional interest in limiting lawsuits
CHAPTER 7 CONCLUSION
LIST OF TABLES
Table 1.1: Medical devices that could be subject to liability suits
Table 1.2: Drugs that could be subject to liability suits


Abstract

Biomanufacturing is an exciting and fundamentally new science that is constantly changing and yielding novel products from emerging technologies. This report A Practical Guide to Biopharmaceutical Manufacturing provides an in-depth understanding of the biopharmaceutical industry. It consists of 10 chapters and highlights the production technologies and operations that occur in the manufacturing facility.

Chapter 1 provides an overview of the biopharmaceutical industry, highlighting the financial and timescale pressures faced during the drug development and manufacturing process, which in part reflect the regulations surrounding the biotechnology industry.

Chapter 2 and 3 are concerned with the production techniques used for the manufacture of a biopharmaceutical.

Chapter 4 describes the process equipment and operations used to support the main production process.

Chapter 5 provides a brief discussion on the design of the biopharmaceutical manufacturing facility, and the monitoring and control methods performed to ensure that the product meets the approved specifications.

Chapter 6 and 7 discuss the benefits and applications of process and cost modelling, present the frameworks used for the modelling and provides examples of the uses of such tools.

Chapter 8 outlines the typical production methods used in the industry to manufacture biotherapeutics by considering sample processes for therapeutics proteins, vaccines, gene therapies and cellular therapies.

Chapter 9 describes the application of the disposable technology, which has a great impact on the operating costs, validation issues and environment concerns in the biopharmaceutical industry.

Finally in chapter 10, the regulatory issues surrounding biopharmaceutical manufacture.


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