Case study on the environmental monitoring for biological manufacturing using Time-lapse Shadow Image Analysis.

Bioburden control in the manufacturing facility is a serious concern regarding biologics due to the possibility of an significant economic impact due to batch failure from a bioburden incident. As a case study on effectively establishing a microbiological environmental monitoring program for cleanrooms, we focused on Time-lapse Shadow Image Analysis as a kind of Rapid Microbiological Method. In this study, the superior rapidity and accuracy were indicated for reference strains and environmental microbial on both 90 mm plate and RODAC plate at 25-30 °C.

Stabilizing effect of β-cyclodextrin on Limaprost, a PGE₁ derivative, in Limaprost alfadex tablets (Opalmon) in highly humid conditions.

Stabilization against humidity of Limaprost (a prostaglandin E₁ derivative), which is currently marketed as Opalmon, was undertaken using β-cyclodextrin (β-CD). Aqueous solutions of Limaprost alfadex/dextran 40 were lyophilized with and without β-CD. Limaprost alfadex lyophilized with β-CD was more chemically stable in humid conditions than that without β-CD.

Identification of fungi based on the nucleotide sequence homology of their internal transcribed spacer 1 (ITS1) region.

In this study, we examined the identification of fungi based on the sequence homology of the internal transcribed spacer 1 (ITS1) region. A newly designed primer pair could amplify the target region of all 42 strains tested. The PCR products were sequenced and the sequence homologies were searched by BLAST.