Development and implementation of novel community outreach methods in women's health issues: the National Centers of Excellence in Women's Health.

Numerous outreach efforts have been employed to educate both lay and professional communities about many medical issues. As part of our contracts with the Public Health Service, Office of Women's Health, Department of Health and Human Services, the National Centers of Excellence (CoEs) in Women's Health have been charged with creating innovative and effective methods of educating these audiences about the major issues involved in women's health. This mission is particularly critical in the arena of women's health, as women are responsible for approximately 75% of the healthcare decisions made by and for American families, and past efforts to provide them with good, evidence-based information have been fraught with difficulties ranging from financial to cultural. We report herein some of our successful novel outreach efforts. A common thread throughout this account is that among the most successful of the outreach activities are those that involve or incorporate existing community groups committed to women's health.

Role of quality control in validation of biopharmaceutical processes: case example of clean-in-place (CIP) procedure for a bioreactor.

If ever clear instruction and close teamwork is needed, it is in the validation of manufacturing processes. All members of the Validation Team need to understand how the Quality Control testing fits into the overall validation work plan. This affords the team members the opportunity to understand how data will be used and avoids a situation where the test results either invalidate or inadequately support the validation plan. A case example is presented for an approach used to validate Clean-in-Place (CIP) procedures for 1600 L bioreactors which are operated on a campaign basis for multi-biopharmaceutical synthesis.

Visualization of time-dependent inactivation of human tumor cathepsin B isozymes by a peptidyl fluoromethyl ketone using a fluorescent print technique.

A peptidyl fluoromethyl ketone (Z-Phe-Ala CH2F) was found to be an effective compound in a time dependent inactivation of cathepsin B isozymes from a number of tissues including human tumors. The effect was visualized by employing an activity-specific fluorescent print technique preceded by isoelectric focusing. The technique could yield additional information of selective inhibition of isozymes as observed with rat pancreas. The fluoromethyl ketone is 30-fold more potent than the known inhibitor of cathepsin B, Z-Phe-AlaCHN2 in parallel evaluation. Furthermore, the fluoromethyl ketone may have in vivo potential in the inhibition of cathepsin B, in view of the results of toxicological studies. The findings demonstrate that the application of enzyme-directed overlay membranes, impregnated with specific substrates, following isoelectric focusing could be very useful in the study of proteases and their involvement in the oncogenic process.