Biotechnology Funding Hits 4-Year High While Startups Seek New Investments
Posted on | January 23, 2012 | No Comments
US FDA’s 2011 guidance documents round-up
Posted on | January 12, 2012 | No Comments
Charles River considering sale, media report claims
Posted on | January 10, 2012 | No Comments
Analytical Method Validation for Biologics, Biopharmaceuticals and Other Therapeutic Products™
Posted on | January 4, 2012 | No Comments
Complex processes yielding complex products such as biologics and biopharmaceuticals demand numerous, non-compendial, and sometimes complex, QC test methods to confirm manufacturing consistency and product quality. This course provides a comprehensive overview of the international regulatory authority requirements and expectations for test method validation of these assays. This course will prepare attendees with the knowledge and tools to plan and execute test method validation packages for the NDA, BLA and MAA market application dossiers, covering in-process, release and stability assays commonly used by QC in biologic and biopharmaceutical companies. The course will cover validation of QC analytical test methods (e.g., electrophoretic, HPLC, peptide mapping, etc.), cell-based potency bioassays, immunochemical binding impurity assays and adventitious agent assays…more“
Who is Assay Depot?
Posted on | September 13, 2011 | Comments Off
Since the marketplace offers services that span the entire drug discovery process, Assay Depot has the goal to ultimately make it possible for a company (or even a single scientist) to run a multi-year drug discovery program from a laptop computer That day is not too far off.
FDA outlines regulatory science strategic plan
Posted on | August 19, 2011 | Comments Off
The FDA has drafted and published a plan to modernize regulatory science. The plan, published earlier this month, is titled “Advancing Regulatory Science at FDA”. In it the agency identifies three key areas of emphasis. These include new approaches to manufacturing and quality, development of new analytical technology and development of novel methodologies for detection of contaminants…more“
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FDA What’s New
World Pharma
Health, Drug, Prescription and GMP
- FDA issues first social media rules for drug companies
- Pot-based Prescription Drug Looks For FDA OK
- New FDA Guidance - Physical-Chemical Identifiers for Anticounterfeiting
- Fact: 80 percent of U.S. pharmaceuticals made with overseas ingredients, nearly half produced in foreign facilities never inspected by FDA