BioPharm International, July 2007 - BioPharm International

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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.
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.
Upstream Processing: Regulatory Considerations Regarding Quality Aspects of Monoclonal Antibodies
By Manfred Kurz
Columns and Departments
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.
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.
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.
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.
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.
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.

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