Technology and Manufacturing Solutions
for the Biopharmaceutical Industry
BioTechLogic, Inc. is a biopharmaceutical manufacturing and CMC consulting firm with strategic and practical/hands-on experience that helps clients bring their products to market quickly and successfully by augmenting and optimizing an organization's technical, manufacturing, analytical, and regulatory 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
Meet BioTechLogic at These Great Events! - 2/10/2010
BioTechLogic will be participating in these upcoming events!
If you or your colleagues will be attending any of these events, contact us now to set up a time to meet and discuss how we assist companies with issues they encounter during the manufacturing and submission of their products.
Biopharmaceutical Development & Production Week |
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3rd Oligo-based |
BioTechLogic Invited to Speak on Panel - 1/20/2010
3rd Annual Oligonucleotide-based Therapeutic Conference:
Where Regulators and Industry Partner to Advance Oligonucleotide Science Together
March 23-25, 2010
DoubleTree Hotel and Executive Meeting Center
Bethesda, MD, USA
Tracy TreDenick, Head of Quality and Regulatory for BioTechLogic, will be participating on the panel for session 5B: CMC Track. She will be discussing "Attributes of Success: Development through Commercialization" and taking part in the Q&A session, as well as availble to meet with interested parties all during the conference.
This conference will serve as a continuum for discussion among Industry and Health Authorities to inform, educate, and share oligonucleotide-based therapeutic product development and regulatory information in the areas of nonclinical, chemistry, manufacturing and control (CMC) and clinical development. These sessions will address targeted therapeutics and exploratory approaches of oligonucleotide-based therapeutic drugs, including bioinformatics, microRNAs, delivery, impurities and metabolism, hresholds and pre-clinical immune screenings prior to IND filing. Delivery technologies are of high priority to expand the therapeutic indications of oligonucleotide-based therapeutics and therefore this conference will also incorporate current dialogue to address RNA interference technologies and expand to the therapeutic segment to discuss emerging technologies for oligonucletoide science.
Meet BioTechLogic at These Great Events! - 1/10/2010
BioTechLogic will be participating in these upcoming events!
 BioPartnering North America 24th - 26th January 2010 Westin Bayshore Resort Vancouver, BC, Canada | If you or your colleagues will be attending any of these events, contact us now to set up a time to meet and discuss how we assist companies with issues they encounter during the manufacturing and submission of their products. |
Cell & Gene Therapy Forum | |
Biomanufacturing Summit |
Presentations
Developing a Sound Process Validation Strategy - BioPharm Magazine December, 2007 - Article written by BioTechLogic's Dave Fetterolf.
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.