ABOUT ADVANCED INSTRUMENTS

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:

Cell Therapies:

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

Gene Therapies:

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

Protein Therapies:

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

Vaccines:

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.

WEBINARS

Osmolality has long been considered a critical measurement in Biopharma describing how much of a solute is present in a given solution. It's increasingly applicable in cell and gene therapies. 

In this webinar, industry experts present a summary of published research showing that, in vector manufacturing, osmolality is a factor in control of stability and aggregation for lentivirus and other viral vector types.

In this tutorial, Bill Saccoccio, AI Service Technician, will cover the available options for archiving data from your osmometer and provide guidance on how to connect to a network, LIMS system, or ELN among, others.

If you’re using or planning to use your Advanced Instruments osmometer in a GMP environment then its level of compliance will be part of the discussion during an inspection by regulators such as MHRA, FDA or others. In this session, Ian Ramsay of Ramsay Pharma talks about the deficiencies typically encountered during inspection, in particular, relating to data integrity.

Developments in MAb and Cell and Gene therapies and the need for “warp speed” vaccine development all bring challenges to the formulation of drug products. This is especially the case in a more heavily regulated biopharmaceutical environment. This workshop will dive into how osmolality measurements aid formulation development strategies to ensure consistent and painless injection whether of rapidly developed vaccines, biologic drugs or cryo-preserved cell therapies.

In this workshop, you’ll hear how osmolality is calculated and why it is a critical parameter useful within different disciplines. When injecting biologic solutions into a patient, the osmolality of the solution can have a significant impact on the cellular osmotic balance. See how osmotic pressure is necessary in ensuring patient safety, with the sensitivity of an osmometer reading ensuring a robust measurement of solute concentration.

Your lab may be tasked with complying to various Pharmacopeia such as USP chapter 785 (to which there have been recent changes), EP and others. In this session, osmometer user Aashni Shah, Senior scientist at GSK talk about their approach to the use of calibrators and controls in their QC release testing. Also we will clarify the current state of play around new software and hardware developments which aid compliance.

We see a trend towards increasingly concentrated drug formulations due, for example, to the decreasing popularity of intravenous administration. This trend presents manufacturing challenges. In this presentation we discuss the challenges associated with high concentration and high viscosity monoclonal antibody formulations, how biopharma manages these challenges today and how the Jefferson Institute addresses these issues. We close the session by discussing the challenges for analytical devices in testing these formulations and how advances in osmolality testing in particular are applied to help minimize the risks.

Did you know that the sampler on your osmometer contains a hidden volume calibration tool? You’ll get tips like this plus guidance on good pipetting techniques, maintenance routines and calibration.

Osmolality is a key process parameter in mammalian cell bioprocesses that affects both specific cell growth and specific cell productivity. Published data shows that hyperosmolality, used in a targeted way at particular stages of the biological production process, for certain cell types, can enhance final product yield significantly. This presentation reviews the strategies that can be used to manipulate osmolality to increase production yields of monoclonal antibodies and other recombinant proteins.

In this presentation we explored the quality and significance of osmolality as a predictor for titer, glucose consumption, and growth-inhibitory by-products such as ammonium in mammalian cell culture. The measurements of different runs were used to establish correlations with osmolality and independent runs to test the predictive power of osmolality. Interestingly the osmolality is a good predictor for glucose, ammonium, and dissolved CO2 among others with a weaker power. The implementation of osmolality measurement and its application in bioprocessing is also discussed.

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.

Learn more about our latest osmometers designed for process development while seamlessly transferring into GMP environments with advanced data management features (21 CFR Part 11) in this presentation, hosted by Kendal Studd, Applications Scientist.

Osmolality serves as a key orthogonal property in downstream processing. This webinar will demonstrate the value of osmolality testing as a key process parameter in buffer preparation, purification, and filtration operations.

FDA warning letters due to incomplete data in the pharma and biotech industries can be prevented by ensuring the reliability of electronic records, a process known as Compliance with Data Integrity. 

Osmolality is a measure of solute concentration and an indication of the solution’s osmotic pressure (USP, EP). 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.

As more people, systems and tools consume data, it becomes increasingly valuable because it can be translated into action to improve quality and performance while reducing costs and time to market. However, with additional systems and users comes a risk that, if not managed correctly, can compromise the integrity of data.

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. There are multiple sensor-based parameters that help monitor a purification process, but which ones serve as predictors for protein concentration?

VIDEOS

This virtual demonstration and overview of the OsmoTECH XT demonstrates how easy the instrument is to use and explains more about its key features. Increase your productivity and reliability with powerful freezing point depression technology for osmolality measurement with the OsmoTECH XT.

Increase your productivity and reliability with powerful freezing point depression technology for osmolality measurement with the all-new OsmoTECH XT single-sample osmometer.  The OsmoTECH XT measures the widest variety of sample types (high concentration, high viscosity) accurately across bioprocessing and cell & gene therapy workflows.

Combining ease-of-use with features that streamline compliance with regulatory standards, the OsmoTECH Single-Sample Micro-Osmometer gives biotech and food and beverage labs the insight into their materials and processes to ensure quality while maximizing productivity.

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.

CONTACT INFORMATION

Advanced Instruments, Inc.

2 Technology Way

Norwood, MA 02062

UNITED STATES

Phone: (781) 320-9000

Contact: Shweta Nair

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