Upstream Processing

Mar 01, 2005
BioPharm International
By BioPharm International Editors
There are challenges aplenty in purification and analysis of PEGylated protein pharmaceuticals. Here are a variety of technical solutions, many concentrating on the chemistry of the linker.
Feb 01, 2005
BioPharm International
By BioPharm International Editors
Disposable products and systems have come a long way since they first entered the small-lab market in the 1970s. Today they are available for practically every aspect of biopharmaceutical manufacturing. Disposable systems are used for filtration, clarification, purification, and separation applications used in the production of vaccines, monoclonal antibodies, and other therapies. As the use of disposable systems grows, the concept of a completely disposable manufacturing process is becoming a reality.
Jan 01, 2005
BioPharm International
In order to institute a GxP mindset across the organization, support and respect for quality systems should come from the top down.
Jan 01, 2005
BioPharm International
Manufacturing changes — such as changes in formulation or source material — can impact a product’s immunogenicity.
May 01, 2004
BioPharm International
By BioPharm International Editors
In October 2003, Shenzhen SiBiono GeneTech made history by becoming the first company approved to market a gene therapy medication. China's State Food and Drug Administration (SFDA) approved Gendicine for treatment of head and neck squamous cell carcinoma (HNSCC). SiBiono believes that continued clinical trials will prove Gendicine to be effective as a wide-spectrum anticancer agent.
Apr 05, 2004
BioPharm International
A profusion of present-day bioreactor and fermentor systems offers remarkably diverse capabilities, ranging from microfluidics to bulk production vats, simple petri dishes to complex artificial organ cultivators, and suspension, adhesion, perfusion, and many other culture management methods. Each of these systems is well suited to address specific research problems, but few are widely adaptable to diverse experiment demands - such as those conducted in space.
Dec 12, 2003
BioPharm International
By BioPharm International Editors
What are the key challenges - and advances - in fermentation and cell culture technology that industry faces over the next five years?
Sep 01, 2003
BioPharm International
By BioPharm International Editors
Biopharmaceuticals are perceived as being at risk of transmitting spongiform encephalopathies to patients, although there has never been such an incident. Clearance studies such as the one described in this article (using a TSE model) can validate inactivation and enhance confidence in the safety of therapeutics produced using animal-derived cell culture supplements.
native1_300x100
lorem ipsum