BioPharm International, July 2007

Features

Vendor Notes: The Biovest AutovaxID: Enabling the Promise of Personalized Medicine

By Mark Hirschel

The AutovaxID is a self-contained, completely enclosed, fully automated hollow fiber bioreactor that permits rapid, efficient scale up of patient-derived cells. It is based on hollow fiber bioreactor technology and is an ideal system for high-density cell culture and the production of monoclonal antibodies or other therapeutic proteins.

Upstream Processing: Regulatory Considerations Regarding Quality Aspects of Monoclonal Antibodies

By Manfred Kurz

Process Development: Maximizing Process Data from Development to Manufacturing

By Claire Hill , Andrew Sinclair

Process development and manufacturing for biopharmaceuticals are often disjointed activities. Disconnects among groups are aggravated by a lack of common terminology and poor data management practices. A UK biotech consortium has initiated a collaborative development effort to address data management issues. The proposed outcome is a data model, based on the ISA-88 Standard for Batch Control, to capture process and facility data throughout the product lifecycle. A data framework that follows the ISA-88 model can simplify process scale up and enable early views of project costs and facility fit.

Columns and Departments

Manufacturers Tackle Neglected Diseases

By Jill Wechsler

Now equipment makers are designing new systems that can be deployed rapidly, are less costly to build, and require less water and power to operate.

Final Word: Are Biotechnology Meetings and Symposia Doing the Job?

By Eric S. Langer

Sir Isaac Newton said, back in 1676, "If I have seen further, it is by standing on the shoulders of Giants." Newton's modest self-assessment of his scientific competence holds relevance in today's debate on the value of scientific meetings, and our quest for faster scientific discovery.

Outsourcing Insights: Why European CMOs Are Coming to America

By Jim Miller

The BIO annual meeting in early May had an upbeat tone. Investment capital is flowing into the industry at high levels, resulting in strong demand for contract development services. The funding stream is particularly strong in the US, and that is attracting more European contract manufacturers (CMOs) eager to improve business development here.

Operations Excellence: Optimizing Efficiency

By Marc Puich

In the April issue of BioPharm International, the article "BioPharmaceutical Operations Roadmap," provided a summary of the key industry gaps executives would like to close in the next 10 years. These goals came to my mind while I was attending Interphex this April in New York.

From the Editor: Learning from the Diethylene Glycol Tragedies

By Laura Bush

Quality guidelines are only as good as their implementation.

Street Talk: Cautious Optimism: the Watchwords for Volatile Sector

By Brian O'Connell

We're seeing an uptick in biotech investing from the venture capital community, a good sign that biotech can rise even higher than the broader markets.

China Today: Next Steps Toward Globalization

By Eric Langer , Eliza Yibing Zhou

Most Chinese biopharmaceuticals are relatively small and there are not enough of them to sustain a robust services sector.