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Upstream Processing: Regulatory Considerations Regarding Quality Aspects of Monoclonal Antibodies

July 1, 2007

China Today: Next Steps Toward Globalization

July 1, 2007

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

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.

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.

Street Talk: Cautious Optimism: the Watchwords for Volatile Sector

July 1, 2007

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

July 1, 2007

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.

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.

Providing a Comprehensive Range of Biopharmaceutical Process Development and cGMP Manufacturing Services

June 2, 2007

Cytovance Biologics is a contract biopharmaceutical process development and cGMP manufacturing organization specializing in products derived from mammalian cell culture. Our highly experienced team of experts is committed to providing best-in-class services that help our customers move recombinant protein and antibody products rapidly and cost-effectively into and through clinical development. We employ a collaborative and flexible approach and business practices that meet the long-term needs of our customers and deliver long-term value and support.

cGMP Custom Manufacturing of Tomorrow's Medicines

June 2, 2007

Cobra Biomanufacturing is dedicated to designing robust processes that deliver high-quality preclinical and clinical biopharmaceutical products for its international life-sciences customers. From proteins and viruses to DNA and cells, Cobra offers a full range of biomanufacturing services and has established an enviable track record in cGMP manufacturing.

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