Biologic Drugs

Apr 21, 2005
Pharmaceutical Technology
By Pharmaceutical Technology Editors
Crucell and NIH Sign Ebola Vaccine Manufacturing Contract
Apr 02, 2005
Pharmaceutical Technology
An increasing number of new compounds are being introduced into pharmaceutical pilot plants.The knowledge base for these compounds regarding their toxicities,physical handling, and cleaning is limited.The authors examine various approaches for addressing the cleaning validation of new compounds and discuss the role of determining appropriate visible residue limits.
Jan 27, 2005
Pharmaceutical Technology
By Pharmaceutical Technology Editors
ISA-88 Automation Standard Gains IEC PAS Status
Oct 02, 2004
Pharmaceutical Technology
Evaluations have shown, in most cases, visual observations are sensitive enough to verify equipment cleanliness. An experiment was conducted to explore the possibility of using a visible-residue limit as an acceptable cleaning limit in a pharmaceutical research facility, including an evaluation of the limits and subjectivity of ?visually clean? equipment.
Jun 01, 2003
Pharmaceutical Technology Europe
Sterilizing grade filters are widely used in the biopharmaceutical industry and were once thought of as being perfect. However, these filters have experienced rapid developments and improvements during the last decade, which have resulted in enhanced thermal and mechanical resistance. Moreover, their performance levels have been raised, which has led to significant cost savings within production processes.
Dec 01, 2002
Pharmaceutical Technology Europe
Ultrafiltration is a pressure-driven membrane filtering process used to separate and/or purify dissolved or suspended particles from water and other liquids. Recent advances in materials and membrane manufacturing techniques have led to ultrafiltration playing a pivotal role in a number of biopharmaceutical processes, including protein concentration and blood for actionation. This article examines the criteria that should be considered when selecting membranes for such applications.
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