Baculovirus Track added to the ISBioTech Annual Meeting Program. «Click Here» for more information

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Integrated Implementation Training Workshop for
ICH Q8, Q9 & Q10

- October 6–8, 2010 -

Downstream Processing of
Biotechnology Products

- September 14-17, 2010 -

Webinar on the
Development of Articles for Rare Diseases

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BioProcessing Journal
We want to make your work available to those who will really appreciate it. Please let us know what you are working on. If you aren’t sure how your material will fit, contact us so we can work with you on the best approach for publishing.

Help us continue a tradition of presenting the latest technological developments and best practices needed to develop and produce safe and effective biologics.

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Suggested Reading
Compliance Program Guidance Manual, Chapter – 45
Biological Drug Products, Inspection of Biological Drug Products (CBER) - 7345.848

Excerpts from MedSun: Newsletter #50, July 2010
What Happens to an Adverse Event Report Submitted to FDA? Take a look at the Adverse Event Flowchart to see what happens when adverse event reports are submitted to the FDA through the MedWatch Adverse Event Reporting program. «Click Here»
Tubing Misconnections: Making the Connection to Patient Safety - Pennsylvania Patient Safety Advisory. One of the main reasons for tubing misconnections is that many types of tubing for different types of medical devices incorporate Luer connectors. Methods for reducing the likelihood of tubing misconnections include equipment design solutions and administrative policies and work practices. «Click Here»
FDA Medical Device Safety - Luer Misconnections. May 12, 2009. «Click Here»

ISBioTech Annual Meeting Update
We’ve added a Baculovirus Track to the ISBioTech Annual Meeting Program in April 2011. While there is tremendous interest in our program tracks on viral, cellular, and protein products, we’ve received a flood of emails from ISBioTech members and other industry leaders who have asked us to cover products derived with baculovirus and insect cell technology. So we’re working with a number of technology experts to recruit the most relevant presentations and posters, and we invite you to submit an abstract to

In addition, we’ve expanded our Cellular Products Track to cover the most critical issues associated with cells, cell lines, and tissues used in bioprocessing.  In particular, our focus will be on cell line development, component traceability, cell banking, cryopreservation, stability, and characterization. Plus we’ll branch out into cellular product applications such as cancer vaccines and tissue regeneration.

Sponsored Links
Vivante GMP Solutions, a leading virus-based biologics CMO, has increased its expert technical staff in the areas of manufacturing, QA and QC. Growth in this sector has been strong, so to keep up with demand, Vivante will expand the team even further later this year. Vivante has the skills needed to convert early stage, lab-grade production into robust and scalable therapeutic product classes suitable for clinical studies and commercial use. «Click Here» or email for more information.

Transient Bulk Transfection by Flow Electroporation. CCS Cell Culture Service has established a new technology by using the MaxCyte® STX Scalable Transfection System to transfect batches of up to 10 billion cells in less than 30 minutes. Cell lines, primary cells and stem cells are reproducibly and efficiently transfected while maintaining the integrity of the cells for subsequent assays. «Click Here» for details, or email

Sponsored Link - Suggested Reading
The Bio-Process Systems Alliance (BPSA) has released its 2010 technical guide: "Recommendations for Testing and Evaluation of Extractables from Single-Use Process Equipment." The 22-page color guide is intended as a “best practices” document, to help suppliers and users of disposable single-use components and systems develop appropriate fluid-specific extractables data that may have applicability in risk-based decisions in bioprocess component selections, process validation, and regulatory filings. «Click Here» to order.

Sponsored Link

The ModPro synthetic protein binder technology is a unique platform that offers the highest affinity and specificity in combination with extreme robustness and chemical versatility for the most demanding applications in diagnostics, drug development, protein separation and purification. No licensing needed from any third party. ModPro combines small organic molecules, or “hot spot” mimics with polypeptides from a designed set to form powerful binders for proteins. The concept is unprecedented and analogous with protein surfaces involved in protein-protein interactions. «Click here» for additional details or email today.

© 2010 ISBioTech