BioPharm International-01-01-2004

BioPharm International

From the Editor—At The Brink of Maturity

January 01, 2004

Columns and Departments

17

1

There are pressures on biopharma to grow up — and to grow up fast. Although we still hear references to its "infancy," I think we're well past that stage and already confronting the awkward — and sometimes painful — experience of adolescence.

Ramping Up and Ensuring Supply Capability for Biopharmaceuticals

January 01, 2004

Improving Operations

17

1

By implementing a comprehensive improvement program for its organizational and operational functions, one company increased capacity by more than 100% and 50% for two of its biopharmaceutical products.

Effective Biopharmaceutical Quality Assurance Units

January 01, 2004

Improving Operations

17

1

Quality assurance units are interwoven throughout the biopharmaceutical enterprise and provide support to sustain operations. Most importantly, they must have the capacity and leadership to adapt to change.

A Major Force in Biotechnology Sweden

January 01, 2004

International BioMarket

17

1

In September 2003, Sweden's biotechnology sector recorded a striking achievement. Amgen, the world's largest biotechnology company, announced plans to acquire exclusive rights to Biovitrum's small-molecule enzyme inhibitors for the treatment of metabolic diseases.

HIV Drugs Produced from Goats Show Promise

January 01, 2004

Product Development

17

1

Molecular mimicry is a common, but undesirable, property of disease proteins. Sequence similarities between cancer proteins and self-proteins allow tumor cells to hide, thereby avoiding attack from the immune system. HIV uses the same evasive tactic.

If Training Is So Easy, Why Isn't Everyone in Compliance?

January 01, 2004

Improving Operations

17

1

Training programs do not have to be complex to be successful. There are basic elements, however, that all must have to meet FDA requirements and ensure that employees have the knowledge and skills to maintain high quality standards.

Outsourcing Outlook: An Overlooked Source of Services: Equipment Vendors

January 01, 2004

Columns and Departments

17

1

Biopharmaceutical companies can access their suppliers? resources to reduce validation and compliance efforts.

Medicare Bill Boosts Coverage for Biotech Therapies

January 01, 2004

Columns and Departments

17

1

New policies revise payment formulas and open the door to increased scrutiny of prices and effectiveness.

StreetTalk: Going Off Patent: Standing Pat or Getting Out

January 01, 2004

Columns and Departments

17

1

Competition from generic drugs is rising. How should investors react when a blockbuster drug goes off patent?