Anogenital Crohn's disease with vitiligo.

Cutaneous Crohn's or anogenital granulomatosis is a rare disorder, which presents commonly as swelling and erosions on anogenital area and associated with features of intestinal Crohn's disease. We report a case of 23-year-old female who presented with vitiligo patches on back and legs for 1-year, painful edema and ulcers on anogenital area and oral cavity for 9 months and diarrhea with bleeding per annum for 1 month. Features on ultrasonography, multislice computed tomography scan, colonoscopy, and biopsy from nodule on anal wall were suggestive of granulomatous Crohn's disease.

Microscale acoustic disruption of mammalian cells for intracellular product release.

High-throughput microscale models for cell culture are critical for biopharmaceutical process development and drug discovery compound screening. While analytical methods are readily available for quantifying cell number and secreted product concentration, the recovery and measurement of intracellular products are significantly affected by the method of cell disruption. For example, the detergents often used in product extraction are incompatible with lipid-enveloped viruses.

Design-for-Six-Sigma To Develop a Bioprocess Knowledge Management Framework.

Unlabelled: Owing to the high costs associated with biopharmaceutical development, considerable pressure has developed for the biopharmaceutical industry to increase productivity by becoming more lean and flexible. The ability to reuse knowledge was identified as one key advantage to streamline productivity, efficiently use resources, and ultimately perform better than the competition. A knowledge management (KM) strategy was assembled for bioprocess-related information using the technique of Design-for-Six-Sigma (DFSS).

Quantitation of interaction of lipids with polymer surfaces in cell culture.

As cell culture medium development efforts have progressed towards leaner, serum-free, and chemically defined formulations, it has become increasingly important to ensure that the appropriate concentrations of all nutrients are maintained and delivered at point of use. In light of concurrent efforts to progress to disposable polymeric storage and culture platforms, the characterization and control of medium component interactions with container surfaces can be a key issue in ensuring consistent delivery of these medium formulations. These studies characterize the interactions of lipids with culture surfaces typically encountered in the bioprocess industry using model systems.

Inactivation of adenovirus type 5 by caustics.

Adenovirus shows significant promise as a vehicle for transfer of therapeutic genes into humans. Based on the importance of this viral vector, it is critical that adequate decontamination procedures are implemented during its large-scale production in multiproduct manufacturing facilities to prevent cross-product contamination and to reduce the risk of personnel exposure. Liquid decontamination procedures based on caustics are easily implemented in a manufacturing setting and are not corrosive to stainless steel surfaces at the concentrations found to inactivate viral proteins and nucleic acids.

Inactivation of adenovirus types 5 and 6 by Virkon S.

Throughout the pharmaceutical industry, adenovirus-based products are being developed for human use as vaccine vectors and gene therapy delivery vehicles. The implementation of effective decontamination procedures is critical to the successful manufacture of these products to minimize the risk of personnel exposure and prevent product cross-contamination in the manufacturing facility. In this investigation, we have conducted small-scale decontamination studies to determine the efficacy of Virkon S on the inactivation of adenovirus types 5 and 6 in suspension.

Thermal inactivation of adenovirus type 5.

Adenovirus-based products are being developed for human use as vaccine constructs and gene therapy vehicles. In order to operate by cGMP guidelines and to address biosafety concerns, it is imperative to ensure that adequate decontamination procedures are implemented in adenovirus manufacturing facilities. Liquid decontamination procedures based on heat treatment are relatively easy to employ in a manufacturing setting.