Upstream Processing

Sep 01, 2007
BioPharm International
By BioPharm International Editors
From the earliest days of the biotechnology industry, companies have grappled with the complexities of making innovative biopharmaceuticals on a large scale. Success in manufacturing begins with process science, since biotech production requires perfection in maintaining living organisms in a sterile environment under controlled physiological conditions. But unless companies can solve the challenge of planning for and managing manufacturing capacity, they will not be able to achieve the full potential of promising biotech products.
Sep 01, 2007
BioPharm International
There were notable approvals in nonparenteral delivery systems and biosimiliars in 2006.
Sep 01, 2007
BioPharm International
In analyzing the industry's current challenges, let's be careful before extrapolating about what they mean.
Aug 21, 2007
BioPharm International
By BioPharm International Editors
SemBioSys Genetics, Inc. (Calgary, Canada, www.sembiosys.com) announced that it has successfully produced commercial levels of apolipoprotein AI and its variant apolipoprotein AI(Milano), collectively referred to as Apo AI, in safflower seed lines.
Aug 02, 2007
BioPharm International
By BioPharm International Editors
Adjuvant-caused vaccine reactions are one of the most important barriers to better acceptance of routine prophylactic vaccination.
Aug 02, 2007
BioPharm International
By BioPharm International Editors
Like the egg-based vaccine production process, producing a vaccine under cGMP conditions using mammalian cells can be a lengthy process, taking a minimum of six to 12 months.
Aug 02, 2007
BioPharm International
Any endpoint considered appropriate to support approval, whether a surrogate or a clinical endpoint, must be supported by substantial evidence of effectiveness.
Aug 02, 2007
BioPharm International
By BioPharm International Editors
Vaccines against strains originating from avian flu may achieve poor yields in egg-based systems. Consequently, both public and private interest in alternative systems is high.
Aug 02, 2007
BioPharm International
By BioPharm International Editors
The recent growth in the vaccine market has led to renewed interest in using adherent human cell lines for vaccine production. Traditionally, small-scale adherent cell line production has been carried out in roller bottles or T-flasks. Over the past few years, however, a number of companies have found multi-tray disposable bioreactors an effective method for producing high-quality drug products using adherent cells. These disposable, expandable systems have also facilitated scale up from laboratory to clinical-scale.
Aug 02, 2007
BioPharm International
By BioPharm International Editors
For many cell-based vaccines, the precursor monocytes or CD34+ cells are cultured with cytokines to obtain dendritic cells, which are very potent antigen-presenting cells (APCs).
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