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CTI Forms Aequus to Develop Alternative to PEGylation

March 22, 2007

Cell Therapeutics, Inc. (CTI, Seattle, WA, www.ctiseattle.com), has formed a new spin-off company, Aequus BioPharma, Inc., to develop a novel process to extend the half-life of proteins.

CMC Strategy Forum Takes on Glycosylation

March 22, 2007

The biopharmaceutical industry has gained a lot of experience in monitoring glycosylation, but still has a lot to learn about the structure–function relationship.

From the Editor: The Industry's Disposition Toward Disposables

March 1, 2007

Disposables are no longer a mistrusted new technology; they're seen as a potential solution to everyday problems.

Outstourcing Insights: Ferment in Biomanufacturing

March 1, 2007

The three largest players have accumulated, or are in the process of accumulating, nearly a million liters of capacity between them.

Operations Excellence: The Critical Path

March 1, 2007

All contributors to the process should have a clear understanding of their capacity and see their work activities as a priority, regardless of where they fall on the critical path.

Upstream Processing:Vendor Notes: Generating Stable, High-Expressing Cell Lines for Recombinant Protein Manufacture

March 1, 2007

Manufacturing recombinant proteins at industrially relevant levels requires technologies that can engineer stable, high-expressing cell lines rapidly, reproducibly, and with relative ease. Commonly used methods incorporate transfection of mammalian cell lines with plasmid DNA containing the gene of interest. Identifying stable, high-expressing transfectants is normally laborious and time consuming. To improve this process, the ACE System has been developed based on pre-engineered artificial chromosomes with multiple recombination acceptor sites. This system allows targeted integration of single or multiple gene copies and eliminates the need for random integration into native host chromosomes. To illustrate the usefulness of the ACE System in generating stable, high-expressing cell lines, we present several case studies covering CHO cell lines expressing monoclonal antibodies.

China Today: Biopharmaceutical Industry Trends in China—A Five-year Prospective

March 1, 2007

The Chinese government's investments in the biopharmaceutical sector may help it become one of the leading industries in China by 2020.

Regulatory Beat: FDA Seeks Safer Drugs and Biologics

March 1, 2007

An underlying theme of FDA's drug safety program is that new discoveries in biomedical science can detect risk issues earlier in clinical development.

IP Briefs: IP Due Diligence: Key to Success in M&A Transactions

March 1, 2007

Although IP due diligence is relevant to virtually any transaction between biotech companies, a detailed investigation into IP assets is particularly critical to M&A transactions.

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