Analysis and evaluation of single-use bag extractables for validation in biopharmaceutical applications.

Unlabelled: This paper describes an approach of extractables determination and gives information on extractables profiles for gamma-sterilized single-use bags with polyethylene inner contact surfaces from five different suppliers. Four extraction solvents were chosen to capture a broad spectrum of extractables. An 80% ethanol extraction was used to extract compounds that represent the bag resin and the organic additives used to stabilize or process the polymer films which would not normally be water-soluble.

Prostaglandin H synthase 2 variant (Val511Ala) in African Americans may reduce the risk for colorectal neoplasia.

Prostaglandin H synthase 2 (also known as cyclooxygenase-2) is thought to play a role in the prevention of colon cancer by aspirin, an inhibitor of the enzyme. We used DNA heteroduplex analysis to screen the prostaglandin H synthase 2 gene, to search for naturally occurring enzyme variants that may simulate the effects of aspirin. We found among African-Americans a single-nucleotide polymorphism that changes valine to alanine at residue 511 (V511A; GTT>GCT; g.

Vitamin D receptor polymorphisms and risk of colorectal adenomas (United States).

Objective: The purpose of this study was to determine whether vitamin D receptor (VDR) gene polymorphisms influence risk of colorectal adenoma.

Methods: Polymorphisms in the 5' and 3' ends of the VDR gene were genotyped for 373 colorectal adenoma cases and 394 controls.

Results: Overall, there was no significant association between the 5' (FokI) or the 3' (BsmI) polymorphisms and adenoma risk.