Thursday, August 8, 2013  |  Volume 5 / Number 16  |  A Production of the BioProcessing Journal
Career Development
Strategies for Accelerating Preclinical Development of Vaccines and Therapeutic Proteins
August 20, 2013
Boston, MA USA
CMC Strategy Forum
Japan 2013
December 9-10, 2013
Tokyo, Japan
6th Monolith Summer School & Symposium
May 30-June 4, 2014
Portorož, Slovenia
Suggested Reading
From the Editor-in-Chief
By Keith L. Carson, BioProcessing Journal
Products & Services
2013 Biological License Application Approvals
The US FDA Center for Biologics Evaluation and Research (CBER) publishes a list of all Biologics License Application (BLA) approvals for each calendar year. Please click here to view the 2013 list of BLAs approved to date. Applications are listed in order by date of approval. This list reflects information regarding the applications as of the approval date, but is not updated with regard to applicant or application status changes.

The BLA is a request for permission to introduce, or deliver for introduction, a biologic product into interstate commerce (21 CFR 601.2), and is regulated under 21 CFR 600–680. A BLA is submitted by any legal person or entity who is engaged in manufacture, or an applicant for a license who takes responsibility for compliance with product and establishment standards.

For more information, please visit www.fda.gov or email industry.biologics@fda.gov.
Solution for Optimizing CHO Cells
WHEATON and Irvine Scientific have collaborated to introduce a high yield, small-scale solution for bioproduction. This solution consists of a WHEATON® CELLine™ bioreactor flask paired with Irvine Scientific’s BalanCD™ CHO Growth A animal component-free, chemically-defined medium. Now, small-scale antibody and protein production can be quickly set up and performed while decreasing the cost per milligram produced.
WHEATON CELLine Bioreactors separate cells from the bulk growth medium by a dialysis membrane that regulates the flow of nutrients and waste products to and from the cell chamber. The lower side of the cell chamber is made of a gas permeable membrane allowing continuous exchange of oxygen and carbon dioxide.

Irvine Scientific's BalanCD CHO Growth A medium, in combination with the CELLine bioreactor, yields antibody levels higher than conventional methods without the use of a mechanical shaker or agitation.
This bundled product is now available through WHEATON and its extensive distributor network.
For more information, please visit WHEATON.com, email CELLine@WHEATON.com, or call 800.225.1437 (USA)/856.825.1100 (International).
Norovirus Monoclonal Antibodies
ViroStat has released two new sets of MONOTOPE™ monoclonal antibodies to the major capsid protein of the GI and GII noroviruses. These new antibodies function in ELISA and lateral flow applications for rapid detection of these viruses. Noroviruses are single-stranded RNA viruses that possess a non-enveloped protein capsid. Norovirus is the leading cause of food-borne illness in the United States.

For more information, please visit virostat-inc.com.

Image credit: Norovirus image courtesy of the Centers for Disease Control.
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