BioTechLogic News

BRUSSELS (Belgium) - April 22, 2008— UCB announced today that the US Food and Drug Administration (FDA) has approved Cimzia® (certolizumab pegol), the first and only PEGylated anti-TNFa (Tumor Necrosis Factor alpha) antibody indicated for reducing signs and symptoms of Crohn's disease and maintaining clinical response in adult patients with moderate to severe active disease who have an inadequate response to conventional therapy.

BioTechLogic's Tracy TreDenick and Patrick Giljum will be teaching a session on US and EU Biologic Regulations at Northwestern University in Evanston, Illinois on April 22, 2008.  The session is part of the Masters in Quality and Regulatory Science at Northwestern University's School of Continuous Studies.

Adeana Dorsey, Manager, Regulatory Affairs and Quality Systems at BioTechLogic has been invited to join the Combination Products Coalition (CPC). In this role, she will provide consultative guidance, working with the FDA, in the development of GMP regulations and regulatory pathways for combination products.

The Combination Product Coalition (CPC) is a group of leading companies in the drug, device and biologics industries working to improve the regulatory environment for combination products by developing and advocating policy positions on regulatory issues affecting combination products. 

David Fetterolf, Associate Director, Manufacturing at BioTechLogic has been invited to join the Editorial Advisory Board of the Journal of GXP Compliance.  In this role, he will be coordinating a series of articles of Biotech Processing.

The Journal of GXP Compliance is the industry's only peer-reviewed Journal exclusively dedicated to providing practical information on:  Good Manufacturing Practice (GMP), Good Laboratory Practice (GLP), and Good Clinical Practice (GCP).

David Fetterolf, Associate Director, Manufacturing at BioTechLogic has been invited to join the Editorial Advisory Board of the Journal of Validation Technology.  In this role, he will be coordinating a series of articles on Biotech Processing.

The Journal of Validation Technology is the only peer-reviewed journal exclusively dedicated to providing practical approaches to conducting effective validations. The journal is Industry's primary source for validation information.  It is published by the Institute of Validation Technology.

Tracy TreDenick, Head of Quality and Regulatory for BioTechLogic, will be  presenting at the DIA EuroMeeting in Barcelona, Spain, March 3-5, 2008.  Tracy's presentation, "Biotechnology:  The Pursuit of Quality in a Globalised World" will be given on Wednesday, March 5 at 2 pm (Theme 11, Session 8).  The DIA (Drug Industry Association) EuroMeeting is one of the premier conferences in Europe for technology professionals in the Pharmaceutical Industry.  Previous DIA meetings have provided exceptional educational and networking opportunities and this one is sure to as well.  If you are planning to attend and would like to meet Tracy, please let us know in the "Contact" section of the website.

Meet BioTechLogic at iBIO IndEx!  Peter Dellva and Tracy TreDenick will be attending the iBIO IndEx on Wednesday, February 20, 2008, 7:00AM-6:30PM at the Hyatt Regency Chicago, Regency Ballroom, 151 East Wacker Drive. The iBIO IndEx is the premier event for the life sciences in our region. This year's IndEx, Capitalizing on Progress, will showcase all that Illinois and the region have to offer.