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At Advanced Instruments, we believe that quality and productivity go hand-in-hand and have built a family of products and services to help biologics manufacturers and process developers ensure the yield, purity, and consistency of biopharmaceutical products through osmolality testing.
Whether you need to maintain optimal cell growth, ensure active pharmaceutical ingredient (API) purity and yield, or confirm quality during fill and finishing, we offer an osmometer that will keep your processes productive and on track, saving time and reducing costly re-work.
Osmolality can be applied across several applications:
When the therapeutic you’re developing is cell-based, constant monitoring to optimize growth and ensure consistent culture conditions throughout multiple stages is critical for success. Osmolality testing can help you determine if:
- Your stem cells at highest viability and product quality levels throughout culture and passaging
- You are ensuring a high rate of cell recovery post-thaw
- If your transduction mechanics are being optimized
Consistency is critical when producing genetic therapies, including viral vector delivery and gene editing. Small deviations in the composition of cell growth media can have unwanted effects on cell density, cell composition, and virus yield. Using osmolality can help your group work towards those goals, as well as answer:
- how to optimize the physiological range for transfection complexes
- identifying media needs
- determining effects of osmotic pressure on the stability of a complex
When it comes to process development and manufacturing of protein therapeutics, whether you’re making an antibody-based or other protein therapeutic, what you don’t know can slow you down. Osmolality can help you determine if
- Your buffers and media are formulated correctly
- If your solution has unexpected components
- The steps involving solutions–i.e. cell growth, dialysis, chromatography – are proceeding consistently and as expected
Osmolality testing is required to ensure that the final vaccine product is safe for administration. The osmolality must be within a physiological range to be introduced in human tissues. There is also evidence that injectable formulations with high osmolality may cause pain at the site of injection.
These are some common use cases for osmolality testing within vaccine development:
- Upstream cell culture and/or cell expansion requires maintaining an environment at the appropriate osmolality for the specific cell type. For those modalities that are cell-based, regular osmolality testing will ensure that the media and environment are optimized.
- Buffers used during any downstream processing should be tested for osmolality to verify the concentrations of the solutions that are meant to protect the drug substance throughout the chromatography and/or filtration operations.
- Final product testing must include osmolality to verify identify and safety of any injectable.
Visit our website, www.aicompanies.com, to learn more about our OsmoTECH ® portfolio of bioprocessing osmometers.
Here we detail the osmolality testing of various formulations containing sodium hyaluronate, with a range of viscosities, including semi-solid gels. The testing is part of a QC check within the end user’s formulation development process, making it a critical part of their work and an example of real-world application of osmolality.
Process development is a critical part in both upstream and downstream and in recent years, osmolality, a measure of solute concentration, has been shown to be strongly implicated across the entire gene therapy process workflow. Data from a recently completed study shows that a significant increase in yield and quality of an AAV was realized from a timed osmolality shift.
Osmolality Is A Predictor For Model-Based Real Time Monitoring Of Concentration In Protein Chromatography
The bottleneck for real time control and real time release is lack of product-specific in-line sensors or fast at-line
methods suitable for model-based prediction of process outcome. Learn how osmolality as an at-line method is an excellent predictor together with UV280 and UV260 for protein quantity in model-based prediction using partial least squares methodology.
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Whilst osmolality is a compendial QC test for final product release, it can also provide the excipient concentration and can confirm the soluble content of formulations.
pH and conductivity measurements can be affected by environmental conditions and are not appropriate concentration measurements for all buffers (e.g. nonionic or weak electrolytes). This study compared osmolality to pH and conductivity across a wide range of concentrations of
common downstream buffers.
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.
Challenges remain to be solved in making cell and gene therapies accessible to larger patient populations. Cell and gene therapy development can benefit from emerging and novel uses for osmolality testing in advanced therapy production.
Osmolality testing has several bioprocessing applications, and new use cases are constantly emerging. This paper evaluates two osmometers for measuring concentrated protein formulations.