Introduction of a process mass intensity metric for biologics.

Biopharmaceuticals (or biologics), large molecule therapeutics typically produced using biotechnology, are a rapidly growing segment of the pharmaceutical market. As such, the environmental footprint of the production of these molecules is coming under scrutiny from various stakeholders such as healthcare providers, investors, and even employees. Process mass intensity (PMI), originally adopted for small molecules by the Green Chemistry Institute Pharmaceutical Roundtable, is a simple metric that can also be applied to evaluate the process efficiency of biopharmaceutical production. PMI for biologics is defined as the total mass input in kg of water, raw materials and consumables, required to make 1 kg of active pharmaceutical ingredient. Six large pharmaceutical companies participated in a benchmarking exercise to calculate the PMI for monoclonal antibody (mAb) production. On average, 7700 kg of input is required to produce 1 kg of mAb. Over 90% of the mass is due to water use, highlighting the water-intensive nature of biologics production.

Rates and correlations of change in three dimensions of recovery within a recovery model oriented therapeutic community.

This is a 10 year longitudinal study of recovery progress within a residential program based upon therapeutic community principles and a Seven Domains Enhanced Recovery Model (Young and Ensing, 1999). A broad suite of measures associated with one of three definitions of recovery (symptom, function, and personal focused recovery) were administered along three longitudinal courses. Normalized mean rates of change and mean shared variances for these scales were examined for three subgroups based on length of stay. Measures associated with the same definition of recovery correlated moderately to strongly but measures did not correlate between facets, suggesting relative independence between definition facets. The results of this analysis suggest the existence of qualitatively distinct subgroups with different change dynamics. The aggregate means of these facets showed correlated change, while individual recovery pathways did not, suggesting significant heterogeneity in individual pathways of recovery. These findings support the conceptualization of recovery as a complex, heterogeneous and multi-faceted process. Practically, these findings emphasize the need for holistic, flexible and individualized recovery supports and that research into these constructs should include at least these facets over a longitudinal time frame.

Early report on the effectiveness of a recovery model oriented therapeutic community for individuals with complex and persistent recovery challenges.

This study summarizes the results of a 10 year longitudinal study of individual recovery progress within a residential program based upon therapeutic community principles and a Seven Domains Enhanced Recovery Model that emerged from a grounded theory analysis of real life recovery experiences (Young and Ensing, Psychiatr Rehab J 22:219-231, 1999). The four primary hypotheses of the study predicted significant and moderately sized effect sizes on a holistic set of measures, corresponding to the Enhanced Recovery Model. Results indicate support for all hypotheses; statistically significant and moderate to large effects were found in all domain measures for the participants, most of whom had multiple unsuccessful previous treatment attempts. These results indicate that this theoretical structure and residential model is effective in supporting recovery for individuals with complex and persistent challenges across the broad range of recovery domains. Conceptually, this also adds quantitative support for the Seven Domains Enhanced Recovery Model, complementing previous qualitative studies.