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Outsourcing Insights: Why European CMOs Are Coming to America

July 1, 2007

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.

Process Development: Maximizing Process Data from Development to Manufacturing

July 1, 2007

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.

From the Editor: Learning from the Diethylene Glycol Tragedies

July 1, 2007

Quality guidelines are only as good as their implementation.

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

July 1, 2007

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.

Manufacturers Tackle Neglected Diseases

July 1, 2007

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?

July 1, 2007

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.

Upstream Processing: Regulatory Considerations Regarding Quality Aspects of Monoclonal Antibodies

July 1, 2007

Economy and Reproducibility: Varying Virus Spike Conditions on a Planova 20N Virus-Removal Filter

June 2, 2007

Introduction; Materials and Methods

On-Demand GMP CMO Capacity through Sequential Cascade BioManufacturing

June 2, 2007

Introduction, Capabilities

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