Newsletter | July 21, 2021

07.21.21 -- Optimizing Cell And Gene Process Development And Manufacturing

8 Ways That Osmolality Testing Improves Cell And Gene Therapy Process Development And Manufacturing

Osmolality is a measure of solute concentration and an indication of the solution’s osmotic pressure. It provides the concentration of any solution and has several potential applications within cell and gene therapy development and manufacturing. Learn more about the role osmolality plays in viral vector stability.

Upstream Applications Of Osmolality Testing In Cell And Gene Therapy Processes

Osmolality can be used as a versatile, robust tool to help improve cell and gene therapies, adding a necessary and beneficial process parameter. This presentation focuses on the incorporation of osmolality testing into upstream applications, which include media development, feeding strategies, and the minimization of aggregation.

Data Integrity And Compliance: What Every Lab Should Know

While FDA 21 CFR Part 11 allows life sciences organizations to use e-records in place of paper, a piece of software by itself cannot be compliant. Any critical software must be supported by a properly conceived and performed validation project, normally following current GMPs. Here's how to develop and perform GMP validation.

Osmolality As A Concentration Measurement Method For Key Buffers In Bioprocessing

The manufacturing of biologics is a complex and costly process by which a protein is recovered and purified of contaminants to ultimately generate a drug product. This is accomplished through a chain of filtration and chromatography processes. This study was conducted to understand how osmolality can serve as a concentration measurement and how it compares to pH and conductivity measurements.

Reliable Osmolality Testing Of High-Concentration Monoclonal Antibody (mAb) Formulations

Osmolality testing has several bioprocessing applications, and new use cases are constantly emerging. The osmolality of monoclonal antibody (mAb) formulations is typically determined using freezing point depression or vapor pressure osmometers. This article evaluates two osmometers for measuring concentrated protein formulations.