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View Sub-Track: Sessions on Biotechnology
Track Sponsored By:
Track Sponsored By:<br> Pall Life Sciences

Thursday, March 04, 2010
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Isolation of Recombinant Human Therapeutic from Inclusion Bodies
Room: 201B ~ 9:00AM - 10:30AM (Thursday, March 04, 2010)
Sponsored by ISPE:

Sponsored By: ISPE Puerto Rico Chapter

Biotechnology Sessions Sponsored by:

Sponsored By: Pall Life Sciences

As new technologies continue emerging in protein expression systems, the ultimate goal of recombinant fermentation processes is achieve high yields and direct processing scalability. Cost-effective production of bio-industrial applications supported by optimized purification procedures must be aligned with the upstream to equalize production capacity.
Bacterial hosts are used to express proteins in the form of insoluble inclusion bodies. This lecture expands on the technologies available used to isolate inclusion bodies from bacterial lysates. The effectiveness of this process step sets the start of the downstream steps to follow in the purification train. Real case studies will be detailed based on process development trials conducted to characterize and scale-up this type of application. Process economics considerations will be presented synchronize the technical and the business aspects.
Speaker:
Gabriel Olmo - Technical & Territory Manager, Pall Biopharm
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Rouging in Biopharmaceutical Manufacturing Systems: Theory, Removal and Prevention
Room: 201B ~ 10:45AM - 12:15PM (Thursday, March 04, 2010)
Biotechnology Sessions Sponsored by:

Sponsored By: Pall Life Sciences

Most pharmaceutical and biotech companies experience some corrosion and rouging of their stainless steel surfaces. Rouge can often be found in high purity water and steam systems as well as process equipment exposed to corrosive environments. There are several factors that can contribute to rouge formation including presence of halides, oxidizing chemistries, extreme pH's, high temperatures, dissimilar metallurgy or defects, improper welding, and inadequate passivation. This presentation will be divided into two parts: Part I will cover the different types of rouge, its formation, and industry practices for derouging and passivating stainless steel, this part will also provide some laboratory generated data (including XPS and Cr/Fe) demonstrating the characteristics and performance of derouging solutions. Part II will focus on presenting case studies including recommendations and procedures at different facilities.
Paul Lopolito - Technical Services Specialist, STERIS Corporation
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Is PCR an Answer to the Need for Rapid Microbiology Tests for Pharmaceutical Products?
Room: 201B ~ 1:45PM - 3:15PM (Thursday, March 04, 2010)
Biotechnology Sessions Sponsored by:

Sponsored By: Pall Life Sciences

Since it’s discovery 25 years ago PCR technology has been widely applied to several different applications ranging from food testing to biodefense. It is gradually making inroads into the pharmaceutical sector. But the big question is: “will the pharmaceutical industry broadly adopt PCR to replace traditional microbiology testing to get faster results?” Presentation will review common concerns and questions with adoption of PCR methods. It will also discuss case study to evaluate the suitability of nucleic acid based systems for pharmaceutical applications. Data will be presented on sensitivity, specificity and accuracy for use in routine pharmaceutical testing with case studies.
Speaker:
Maitry Ganatra , Pall Life Sciences

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