Conversion of an intensified fed-batch to an integrated continuous bioprocess

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Engaging an unstably housed population with low-barrier buprenorphine treatment at a syringe services program: Lessons learned from Seattle, Washington.

Background: Clinic-imposed barriers can impede access to medication for opioid use disorder (MOUD). We evaluated a low-barrier buprenorphine program that is co-located with a syringe services program (SSP) in Seattle, Washington, USA. Methods: We analyzed medical record data corresponding to patients who enrolled into the buprenorphine program in its first year of operation. We used descriptive statistics and tests of association to longitudinally evaluate retention, cumulative number of days buprenorphine was prescribed, and toxicology results. Results: Demand for buprenorphine among SSP clients initially surpassed programmatic capacity. Of the 146 enrolled patients, the majority (82%) were unstably housed. Patients were prescribed buprenorphine for a median of 47 days (interquartile range [IQR] = 8-147) in the 180 days following enrollment. Between the first and sixth visits, the percentage of toxicology tests that was positive for buprenorphine significantly increased (33% to 96%, P \u3c .0001) and other opioids significantly decreased (90% to 41%, P \u3c .0001) and plateaued thereafter. Toxicology test results for stimulants, benzodiazepines, and barbiturates did not significantly change. Conclusions: SSP served as an effective point of entry for a low-barrier MOUD program. A large proportion of enrolled patients demonstrated sustained retention and reductions in opioid use, despite housing instability and polysubstance use

CureGN Study Rationale, Design, and Methods: Establishing a Large Prospective Observational Study of Glomerular Disease

Glomerular diseases, including minimal change disease, focal segmental glomerulosclerosis, membranous nephropathy, and immunoglobulin A (IgA) nephropathy, share clinical presentations, yet result from multiple biological mechanisms. Challenges to identifying underlying mechanisms, biomarkers, and new therapies include the rarity of each diagnosis and slow progression, often requiring decades to measure the effectiveness of interventions to prevent end-stage kidney disease (ESKD) or death. Multicenter prospective cohort study. Cure Glomerulonephropathy (CureGN) will enroll 2,400 children and adults with minimal change disease, focal segmental glomerulosclerosis, membranous nephropathy, or IgA nephropathy (including IgA vasculitis) and a first diagnostic kidney biopsy within 5 years. Patients with ESKD and those with secondary causes of glomerular disease are excluded. Clinical data, including medical history, medications, family history, and patient-reported outcomes, are obtained, along with a digital archive of kidney biopsy images and blood and urine specimens at study visits aligned with clinical care 1 to 4 times per year. Patients are followed up for changes in estimated glomerular filtration rate, disease activity, ESKD, and death and for nonrenal complications of disease and treatment, including infection, malignancy, cardiovascular, and thromboembolic events. The study design supports multiple longitudinal analyses leveraging the diverse data domains of CureGN and its ancillary program. At 2,400 patients and an average of 2 years’ initial follow-up, CureGN has 80% power to detect an HR of 1.4 to 1.9 for proteinuria remission and a mean difference of 2.1 to 3.0mL/min/1.73m2 in estimated glomerular filtration rate per year. Current follow-up can only detect large differences in ESKD and death outcomes. Study infrastructure will support a broad range of scientific approaches to identify mechanistically distinct subgroups, identify accurate biomarkers of disease activity and progression, delineate disease-specific treatment targets, and inform future therapeutic trials. CureGN is expected to be among the largest prospective studies of children and adults with glomerular disease, with a broad goal to lessen disease burden and improve outcomes