Pharmaceutical Technologist - September 2007 - (Page 32)

Q&A // There have also been developments in unit operations that clear DNA, host cell protein and viruses using membrane chromatography, which can now be performed at large process volumes using single-use devices. Another popular misconception is that single-use technologies produce more waste. Environmental impact is actually small compared with the solid plastic waste produced per year in laboratories. The total environmental impact is much less than producing and disposing of cleaning chemicals for stainless steel containers, and research is being encouraged by the Bioprocess Systems Alliance to compare the energy consumed by single-use technologies. How has your customer-base changed? There has been an increase in smaller biotech companies and contract manufacturing organizations (CMOs). The flexibility that single use provides is useful for companies that may need to manufacture smaller batches; for example, in clinical trials. In some cases, the adopting single-use technologies enables early-stage companies to manufacture without the investment overheads traditionally associated with pharmaceutical production. Are there any regional trends? Disposable manufacturing is expanding rapidly in Europe and the US, less so in Asia and Latin America. Can you illustrate the benefits of biodisposables with a practical example? Vaccine manufacturing has been under increased regulatory scrutiny because of cleanliness issues. There have been a number of documented issues of contamination during aseptic processing of egg-based vaccines related to difficulties in cleaning stainless equipment. These, and many other traditional processes, are being converted to single-use Schematic diagram of a disposable biopharmaceutical process. Source: Pall Life Sciences Upstream Vent Harvest Cell harvesting Clarification Media preparation Downstream DNA/HCP removal Fermentor/ Bioreactor Buffer preparation Diafiltration Purification Diafiltration Form and Fill Sterile filtration Holding Bag Capture Virus removal Concentration/ Diafiltration Virus removal Sterile filtration Final product 32 September 2007 l pharmaceutical technologist

Table of Contents Feed for the Digital Edition of Pharmaceutical Technologist - September 2007

Contents Editor’s Comment News Morpheus Market Watch CPhI Worldwide 2007 Compliant Pharmaceutical Labelling Q&A

Pharmaceutical Technologist - September 2007

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