is a recognized expert in the development of cell and gene therapies with more than 9 years of experience at the FDA's CBER
, 15 years of biotech industrial experience in research, product and intellectual property development, and 9 years at the National Cancer Institute.
cites that a key advantage of single-use bioreactor bags is flexibility.
"Historically, industry researchers used high shear viscosity (HSV) or Capillary Breakup Extensional Rheometer (CBER
) to assess capillary thinning and the filament formation dynamics of paint.
She conducted complex inspections in the bioresearch monitoring program for CDRH, CDER and CBER
including inspections of clinical investigators and institutional review boards.
Since then, according to the Case-Shiller index, produced by Standard & Poor's and published by the Center for Business & Economic Research (CBER
) at the University of Nevada--Las Vegas' (UNLV'S) Lee Business School, Las Vegas home prices have risen by 5.7%.
We recently successfully completed an FDA (CBER
) Pre-Approval Inspection in support of a biologic product launch for another long-term contract customer.
The company said the approval marks two important firsts: the first-ever approval of an allogeneic cell product via the Center for Biologics and Evaluation Research (CBER
) arm of the FDA, and the first cell-based technology that is FDA-approved for use in the dental market.
GlaxoSmithKline (GSK) announced that US Food and Drug Administration''s (FDA) Centre for Biological Evaluation and Research (CBER
) had released the first lots of FluLaval, an influenza virus vaccine.
Package testing requirements for combination products can be found in CBER
Guidance for Container Closure Systems for Packaging Human Drugs and Biologics and CDER Guidance for Stability Testing of Drug Substances and Drug Products.
After a single dose of each vaccine, children aged 9-17 years met the Food and Drug Administration's Center for Biologics Evaluation and Research (CBER
) criteria for immunogenicity, but "in children 3-8 years of age, only the 7.5-mcg dose of 2009 H1N1 vaccine with adjuvant met both the immunogenicity criteria after one dose," Dr.
When the Cellular, Tissue and Gene Therapies Advisory Committee of the FDA's Center for Biologics Evaluation and Research (CBER
) considered the application last March, the vaccine had failed its second phase III trial.