BioTechLogic, Inc. is a biopharmaceutical and technology management firm with a unique, proven capability to rapidly and successfully bring products to market through the augmentation and optimization of a corporation's technical resources.
We are a team of professionals with expertise in process development, BioAnalytical services, process validation, project management, quality assurance, regulatory submissions and Pre-Approval Inspection (PAI) readiness. Our quality by design (QbD) approach enables us to effectively provide product development support, including: development reports, design of experiments, technology implementation, critical process parameter evaluation, technology transfer and scale-up, and on-site third party contract manufacturing support.
Latest BioTechLogic News
Cimzia Approved in the US for the Treatment of Moderate to Severe Crohn's Disease - 4/23/2008
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.
Tracy TreDenick and Patrick Giljum Presenting at Northwestern University - 4/16/2008
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.
BioTechLogic's Adeana Dorsey invited to join the Combination Products Coalition (CPC) - 4/14/2008
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.
Highlights of WCBP 2008 Meeting in Washington, D.C. - BioTechLogic's Mike Rooney attended this U.S. FDA co-sponsored meeting addressing analytical/regulatory for biotechnology products and prepared this summary.
Process Validation of 1018 ISS - Validation of the Oligonucleotide Manufacturing Process - Presented by Mark C. Guzman at TIDES 2007
Pre-Approval Inspection & Managing Risk - PDA Presentation - August 2005