Process Optimization with Osmolality Testing | Advanced instruments
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Process Optimization with Osmolality Testing



Optimizing Processes Throughout Development

Biopharmaceutical development and manufacturing involves many complex steps. Ensuring that these processes consistently produce a biopharmaceutical product of predetermined yield, purity, and quality is of utmost importance.

To optimize your manufacturing processes, osmolality can be used to monitor cell culture and fermentation to ensure optimal cell health, and consequently, high product quality and yield.

Through process optimization, you can ensure precise buffer preparation and prove complete buffer exchange to improve purification efficiency while safeguarding your biologics as it passes through storage, reconstitution, and injection.

Applications

Cell Line Development

Osmolality can be used in several different ways during cell line development to help provide an ideal environment for cells to reach optimal attributes and improve the yield of cell and gene therapy products.

Cell media with higher osmolality has been used to maximize productivity by increasing specific production rates of waste and/or slow cell growth. It is critical to closely monitor the osmolality level of your media as extreme osmolality in media can compromise cell growth which can negatively impact yield or lead to batch failures.

Cell Culture Monitoring

Osmolality continues to serve as a Critical Process Parameter (CPP) in cell culture monitoring. Consumption of media substrates and production of waste by the cells create a dynamic osmolality profile. Additionally, different feeding and supplementation strategies, as well as pH control strategies using specific gas levels, will impact the osmolality differently [1, 2].

Osmolality is a critical indicator of lactate production (influenced by pH) and media base addition, ultimately impacting glycosylation in cell culture. Monitoring this parameter is essential to understanding and optimizing growth and productivity.

Learn about more applications of osmolality in our whitepaper – 8 Ways That Osmolality Testing Improves Cell and Gene Therapy Processing

References

  1. Ferreira, T.B., et al., Two different serum-free media and osmolality effect upon human 293 cell growth and adenovirus production. Biotechnol Lett, 2005. 27(22): p. 1809-13.
  2. Gilbert, A., Y. Huang, and T. Ryll, Identifying and eliminating cell culture process variability. Pharm. Bioprocess., 2014. 2(6): p. 519-534.

Buffer Exchange

Support high filtration recovery for high product yield using Osmolality during Ultrafiltration/diafiltration (UF/DF) and tangential flow filtration (TFF).

Viruses, especially lentiviruses (LVs), are much larger than mAbs, so getting high recovery and consistent process performance during UF/DF can be difficult. Osmolality plays a crucial role in reducing the potential for Adeno-associated virus (AAV) aggregation and has been used to check levels of excipients that prevent the build-up of AAV2 vectors improving yield during this critical step.

For diafiltration (DF) runs preceding formulation, osmolality testing can be used to check the efficiency of buffer exchange. It can also be used to assess the optimal number of diavolumes (DVs) by monitoring the osmolality trend and determine when a plateau occurs.

Learn more in our Application Note – Osmolality as a concentration measurement method for key buffers in bioprocessing

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JIB Paper Educational Resource Tile Dec 2020

Reliable Osmolality Testing of High Concentration mAb Formulations

Osmolality: A Predictor in Mammalian Cell Culture

Upstream Applications of Osmolality Testing in Cell & Gene Therapy Processes

The Future of Osmolality Testing Within Cell and Gene Therapy

An Insider’s Look: How One Parameter Can Optimize Key Phases of Bioprocessing Workflows

Maximizing Product Titer By Strategic Control of Osmolality in Mammalian Cell Bioprocesses

Designed to meet the high sample throughput, regulatory compliance (including 21 CFR part 11), and data management needs of busy bioprocessing and biomanufacturing labs, the OsmoTECH PRO Multi-Sample Micro-Osmometer combines ease-of-use with accurate and precise osmolality measurements for reliable and reproducible results. Optimize and ensure the quality and consistency of buffers, media, product, excipients, and process parameters to maximize biologic yield, quality, and purity.

Increase your productivity and reliability with powerful freezing point depression technology for osmolality measurement with the all-new OsmoTECH® XT single-sample micro-osmometer.  The OsmoTECH XT measures the widest variety of sample types (protein/sugar concentration, viscosity) accurately across bioprocessing and cell & gene therapy workflows. It’s also designed to make your work as streamlined and comfortable as possible with even more robust data integrity and compliance features to match your digital environment.