Upstream Processing

Sep 02, 2006
BioPharm International
By BioPharm International Editors
Established, fully validated methodology and SOPs are required prior to initiation of any training activities.
Sep 01, 2006
BioPharm International
By BioPharm International Editors
Steam traps are part of a steam-in-place system. The current design allots 18 in. of vertical leg for condensate backup. A design with a sensitive bellows has been proven in laboratory tests to need only 6 in. of vertical leg during the 15 min. of 121?C sterilization. Loads of 1 to 27 lb/h are covered by the capability of the new trap, equivalent to required steam for vessels 20 to 40,000 L.
Sep 01, 2006
BioPharm International
By BioPharm International Editors
Companies faced with real or threatened FDA sanctions are usually least prepared to react effectively.
Aug 02, 2006
BioPharm International
By BioPharm International Editors
Nothing beats a good dictionary. It can clarify doubts, settle an argument, or prompt exploration into new areas of learning.
Aug 01, 2006
BioPharm International
Capital investments in production plants represent a significant portion of the cost of new recombinant drugs
Aug 01, 2006
BioPharm International
By BioPharm International Editors
Understand your company's requirements, define responsibilities,and manage your team effectively.
Jul 01, 2006
BioPharm International
The approvals of two groundbreaking vaccines in the last month is encouraging news. Vaccines have long been undervalued because they haven't been as profitable as other pharmaceuticals. So it's good to see them getting deserved attention that goes beyond fears of flu outbreaks.
Jul 01, 2006
BioPharm International
By BioPharm International Editors
Disposables require less space than conventional equipment, and they can be assembled offsite into complete process trains.
Jun 27, 2006
BioPharm International
By BioPharm International Editors
Several recent approvals highlight progress in developing both prophylactic and therapeutic vaccines.
Jun 27, 2006
BioPharm International
"Clinical data is the gold standard" for setting manufacturing specifications, said Patrick Swann, PhD, acting deputy director of the Division of Monoclonal Antibodies at FDA, at a session on specification setting at the AAPS National Biotechnology Conference that was held June 19-21 in Boston.
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