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OsmoTECH® HT Automated Micro-Osmometer

1 Reviews
Highlighted Features

● Automation-friendly 96-well plate-based format
● Small sample volume requirement
● The gold standard freezing point depression technology
● Flexible and secure data management
● Supports 21 CFR part 11 and GMP

1 Reviews

OsmoTECH® HT Automated Micro-Osmometer

Pharma Manufacturing - 2022 Pharma Innovation Award winner

96 Well Plate-Based Osmometer for High-Throughput Labs

The OsmoTECH HT, is the only plate-based micro-osmometer currently available to support the growing automation and high throughput needs in bioprocessing. Designed in a 96 well format this automation-friendly instrument ensures efficiency and acceleration of osmolality testing in cell line development, clone screening, early process, and formulation development. The OsmoTECH HT provides intuitive workflows and delivers unsurpassed data management and connectivity with 21 CFR Part 11 compliance features for GMP workflows.

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“Easy to use, reliable, and increases walk-away time!”

“Equipment was easy to set up and easy to use. It runs reliably and is great to have for running many samples.”

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Overview

Upstream Manufacturing Applications

CLONE SCREENING

Speed to market, boost cell longevity, increase yield and reduce production costs — Know more about your clones sooner and select the best clones earlier in the process.

CELL LINE DEVELOPMENT

Boost cell longevity and maximize cell productivity — Optimize osmolality when developing new feeds and additives in cell culture to increase cell longevity.

FORMULATION DEVELOPMENT

Accelerate formulation development and stability testing — Integrate into automated workflows providing excipient concentrations and confirm the soluble content of formulations.

Product Features

EFFORTLESSLY RUN MULTIPLE SAMPLES

The plate-loading format allows samples to be robotically pipetted into the 96-well plate. Load up to two plates onto the device for 192 tests.

AUTOMATION-FRIENDLY WORKFLOWS

Streamline efficiency and reduce hands-on operator time with seamless integration with automation workflows using Ambr®, Cedex® and liquid handling automation systems

MINIMIZE CONSUMABLES REPLACEMENT

Perform up to 1,000 tests before a consumables change is required. Uninterrupted sample testing overnight, weekend, and even holidays.

CONSERVE VITAL SAMPLES

Just a 40µL sample volume is needed for early process osmolality testing; 20 uL for STAT testing.

USER-FRIENDLY INTERFACE

An intuitive operating system and touchscreen interface provides a step-by-step guide to tests and allow users to easily get the status of tests and consumables.

ASSURE ACCURACY

Custom covers seal the plate to prevent sample evaporation to ensure repeatable and reliable results.

FLEXIBLE AND SECURE DATA MANAGEMENT

Quickly save data to a network database, USB device or web server. Automate the sample identification process and instrument control with bi-directional communication to eliminate transcription errors and save time. Easily integrate your results into a data management system and batch records with OPC-UA.

AUTOMATED SELF-CLEANING

Eliminate sample carryover and cross-contamination with automated sampling and fluid cleaning.

CUSTOMIZABLE TEMPLATES

Develop and store templates to reduce set-up time when testing large numbers of samples from bioreactors in your high-volume workflow.

SUPPORT COMPLIANCE

Data integrity features support 21 CFR part 11 compliance for ease of implementation into a GMP environment.

BACKED BY COMPREHENSIVE SUPPORT

Every Advanced Instruments osmometer is backed by a knowledgeable, experienced and responsive customer support team for complete confidence in your instrument.

Ambr® is a registered trademark of Sartorius AG, Cedex® is a registered trademark of F. Hoffmann-La Roche Ltd,

Technical Specifications

Sample type Aqueous-based solution
Sample volume per test 40 μL
Test time 140 seconds
Sample Capacity Multi plate
Resolution 1 mOsm/kg H2O
Range1 0-2000 mOsm/kg H2O
Accuracy2
(AI standards and reference solutions)		 Mean value ±3 mOsm/kg H2O from nominal value between 0 and 400 mOsm/kg H2O (1 SD)
Mean value ±1% from nominal value greater than 400 to 2000 mOsm/ kg H2O (1 SD)
Within-run Repeatability2
(AI Standards and Reference Solutions)		 Standard deviation ≤3 mOsm/kg H2O between 0 and 400 mOsm/kg H2O
Coefficient of variation ≤1% greater than 400 to 2000 mOsm/kg H2O
Operating conditions Temperature: 18 °C to 35 °C (64 °F to 95 °F)
Humidity: 5 to 80% relative humidity (non-condensing)
Supported Languages English, Simplified Chinese, French, German, Italian, Japanese, Korean, Portuguese, Russian, Spanish, Turkish
Storage temperature -20°C to +45°C (-4°F to +113°F)
Electrical voltage 100 to 240 VAC (50/60 Hz)
Power consumption 60 Watts
Dimensions (D x W x H) 48.9 cm D x 62.87 cm W x 68.58 cm H (19.25” D X 24.75” W X 27 H”)
Net weight 59.7 kg (131.6 lbs.)
Shipping weight 111.9 kg (246.6 lbs.)
Warranty One-year limited warranty on workmanship and parts
  1. Advanced Instruments completes testing from 0 mOsm/kg sample to 2000 mOsm/kg sample during in-house linearity testing.
  2. Performance at reference conditions: 20 °C to 25 °C (68 °F to 77 °F); 30 to 60% relative humidity.

Associated Products

Osmometer Calibration Standards and Reference Solutions

SK-TECHHTOsmoTECH HT Convenience Kit ( Includes 3MA635 , 635910, 635934 , 635920, 3MA029, 3LA028, 202850)
3MA635OsmoTECH HT Calibration and Verification Standard Set

Supplies

635920OsmoTECH HT 96 Well Plate Kit
635934OsmoTECH HT System Fluid
635910OsmoTECH HT Cleaning Reel
HT1000OsmoTECH HT Micro-Sample Tubes, Pkg 1000
240821Sampler Tips, 50/pkg

Accessories

135022Epson Dot Matrix Printer (sold-separately)
AN2TP5Dot Matrix Printer Paper
700056Barcode scanner
Clinitrol 290 Reference Solution

10 x 2mL Ampules

View Product
Osmolality Linearity Set

0, 500, 900, 1500, 2000 mOsm/kg H2O 5x 2x 2mL Ampules

View Product

Applications

Applications

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.

  • Are all of your buffers and media formulated correctly?
  • Does your solution have unexpected components?
  • Are all of the steps involving solutions–i.e. cell growth, dialysis, chromatography–proceeding consistently and as expected?

With the innovative osmometers from Advanced Instruments, you can gain valuable data for managing process and product quality through a simple 90-second test. Osmolality, the measurement of total solute concentration, is a reliable control specification and in-process parameter that can deliver information across the protein therapeutic process development and manufacturing workflow.

See all Advanced Osmometers >

Upstream

Optimize cell culture conditions to maximize cell density and yield.

Cell-Line-Development_TItle

Cell Line Development

Ensure that culture conditions are compatible with your clone and cell culture system contributing to optimal cell density and tite.
Media-Preparation_Title

Media Preparation

Check media composition for optimal cell growth.
Cell-CultureMonitoring_Title

Cell Culture Monitoring

Ensure that culture conditions are correct for proper growth and health of cells. This promotes maximum density and yield.
Downstream

Monitor buffer composition and processes, such as chromatography and filtration, to ensure protein purity and yield.

BufferPreparation_Title

Buffer Preparation

Check for proper buffer composition for efficient processing and optimal quality and yield.
Chromatography_Title

Chromatography

Maintain the purity of the drug intermediates and identify and process deviations that could compromise product yield.
Buffer-Exchange_TItle

Buffer Exchange

Monitor buffer composition and verify proper exchange to optimize the number of diavolumes and acquire the highest product yield with the highest quality.
Fill & Finish

Monitor and verify the concentration of API and excipients to meet internal quality and regulatory requirements

FormulationDevelopment_title

Formulation Development

Optimize formulation concentration and stability for high yield in manufacturing.
Final-Formulation_Title

Final Formulation

Monitor and/or verify the concentration of excipients. Confirm soluble content of formulations. Minimize injection site pain.
Filtration_and_Fill_Title

Filtration and Fill

Key compendial release specification to confirm product stability.

Application Notes

  1. Osmolality as a concentration measurement method for key buffers in bioprocessing (Poster)
  2. Osmolality as a concentration measurement method for key buffers in bioprocessing (Application Note)
  3. Osmolality as a valuable tool in formulation studies for advanced therapies (Poster)
  4. Osmolality as a predictor for model-based real-time monitoring of concentration in protein chromatography (Research Paper)
  5. Reliable Osmolality Testing of High Concentration mAb Formulations (Scientific Resource)

References

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.

  • Are your stem cells at highest viability and product quality levels throughout culture and passaging?
  • Are you ensuring a high rate of cell recovery post-thaw?
  • Are the methods and processes used for transduction optimized for your system?

Using osmolality can help your group answer these questions early in the process, ultimately helping you save time, money, and limited or costly reagents. Adding a simple 90-second osmolality measurement to the in-process parameters you measure is a quick and easy way to ensure optimal cell growth, during process development and manufacturing as well as during buffer and media preparation.

With the innovative osmometers from Advanced Instruments, you can keep delicate cells at optimal growth and gain valuable data for managing process and product quality across the cell therapy process development and manufacturing workflow.

See all Advanced Osmometers >

Looking for more information on how osmolality can be an important tool in the formulation of cellular & T-cell based therapies? Check out this in-depth article published on MDPI by a GSK’s R&D group in the UK.

Learn More
Upstream

Characterize media and optimize transduction of cells with lentivirus to optimize cell viability and size.

Cell-Line-Development_TItle

Cell Line Development

Ensure appropriate trending by monitoring small-scale cell culture for some cell therapies.
Media-Preparation_Title

Media Preparation

Characterize media formulation and QC raw materials for optimal cell growth.
Cell-CultureMonitoring_Title

Cell Culture Monitoring

Ensure that culture conditions are correct for proper growth and health of cells. This promotes maximum cell viability.
Downstream

Optimize downstream processing by confirming buffer concentrations and minimizing shock to cells.

BufferPreparation_Title

Buffer Preparation

Check for proper buffer composition for efficient processing and optimal quality and yield.
Chromatography_Title

Chromatography

Maintain purification conditions to maximize yield and protect cells.
Buffer-Exchange_TItle

Buffer Exchange

Optimize solution concentrations for UF/DF concentration and buffer exchange to acquire the highest product yield with the highest quality.
Fill & Finish

Monitor and ensure final composition and manage cryopreservation and storage.

FormulationDevelopment_title

Formulation Development

Optimize formulation concentration and composition drug safety.
Final-Formulation_Title

Final Formulation

Confirm concentration of formulations and ensure compatibility of cells with cryopreservatives.
Filtration_and_Fill_Title

Formulation and Fill

Key compendial release specification to confirm stability.

Application Notes

  1. 8 Ways That Osmolality Testing Improves Cell and Gene Therapy Processing (Scientific Resource)
  2. Osmolality as a concentration measurement method for key buffers in bioprocessing (Poster)
  3. Osmolality as a concentration measurement method for key buffers in bioprocessing (Application Note)
  4. Osmolality as a valuable tool in the cryopreservation of advanced therapies (Poster)

References

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.

  • Are you looking for ways to increase vector stability?
  • Is your gene therapy group looking for higher transfection efficiency and higher viral vector production?

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

With the innovative osmometers from Advanced Instruments, you can gain valuable data for managing process and product quality through a simple 90-second test. When done right, osmolality, the measurement of total solute concentration, is a reliable control specification and in-process parameter that can deliver information across the gene therapy process development and manufacturing workflow.

See all Advanced Osmometers >

Looking for more information on how osmolality can be an important tool in supporting QbD in Cell and Gene Therapy manufacturing processes? Check out this in-depth article published by the Alliance for Regenerative Medicine in partnership with NIMBL.

Learn More
Upstream

Optimize cell culture conditions and media selection to maximize cell density, size and, ultimately, virus yield.

Cell-Line-Development_TItle

Cell Line Development

Ensure that culture conditions are compatible with your clone and cell culture system, contributing to optimal cell density and titer. Maximize transfection efficiency for optimal yield.
Media-Preparation_Title

Media Preparation

Characterize media preparation and composition for optimal cell growth.
Cell-CultureMonitoring_Title

Cell Culture Monitoring

Ensure that culture conditions are correct for proper growth and health of cells. This promotes maximum cell density and yield.
Downstream

Check raw material concentration and perform in-process monitoring of purification and filtration steps to maximize purity, cell/virus stability, and yield.

BufferPreparation_Title

Buffer Preparation

Check for proper buffer composition for efficient processing and optimal quality and yield.
Chromatography_Title

Chromatography

Maintain the purity of the drug intermediates, protect the viral vector and genetic content within the vector during process, and identify process deviations that could compromise product yield.
Buffer-Exchange_TItle

Buffer Exchange

Monitor buffer composition and verify proper exchange to optimize the number of diavolumes and acquire the highest product yield with the highest quality.
Fill & Finish

Monitor and ensure final composition, dosage, and stability

FormulationDevelopment_title

Formulation Development

Optimize formulation concentration and composition for high yield in manufacturing.
Final-Formulation_Title

Final Formulation

Monitor and/or verify the concentration of excipients. Confirm soluble content (solute concentrations) of formulations. Ensure compatibility of precious product with cryopreservatives.
Filtration_and_Fill_Title

Filtration and Fill

Key compendial release specification to confirm product dosage specifications.

Application Notes

  1. 8 Ways That Osmolality Testing Improves Cell and Gene Therapy Processing (Scientific Resource)
  2. Osmolality as a concentration measurement method for key buffers in bioprocessing (Poster)
  3. Osmolality as a concentration measurement method for key buffers in bioprocessing (Application Note)
  4. Osmolality as a valuable tool in the cryopreservation of advanced therapies (Poster)

References

Personal Care

Osmolality testing has unlimited applications in areas of personal care and hygiene. Products that come into contact with or penetrate the skin must have an osmolality within a physiological range to avoid damaging cells and tissues. In some instances, slightly hypo- or hyper-osmotic solutions are generated to promote wetting or drying effects. The manufacturing of skincare products, personal lubricants and optical products

One key to a youthful look is healthy and moisturized skin. Proper hydration of skin depends on a balance of water flow into and out of skin cells and, thus, depends on osmolality. Osmolality testing of skincare products provides assurance that the product will have moisturizing effects and serves as a control during the production process.

The osmolality of personal lubricant formulations impacts their effect and safety. The World Health Organization (WHO) stated that the osmolality of these solutions should not exceed 1200 mOsm/kg, with this limit decreasing to a more iso-osmotic level in the future.

Similar value for osmolality testing can be clearly seen in optical applications. Eye drops and other optical products are designed to lubricate or protect the eye. The goal of these solutions (e.g. adding moisture, removing moisture, etc.) dictates an ideal osmolality range.

See all Advanced Osmometers >

References

  • Aragona P et al. Physiochemical Properties of Hyaluronic Acid-Based Lubricant Eye Drops. Trans Vis Sci Tech. 2019;8(6):2.
  • Corrales R et al. Effects of Osmoprotectants on Hyperosmolar Stress in Cultured Human Corneal Epithelial Cells. Cornea 2008;27:574-579.
  • WHO/UNFPA/FHI, 2011-. Advisory Committee Notes to the Female Condom Technical Review Committee Meeting. [Geneva, Switzerland].

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.

Vaccines are derived from a variety of sources, both living and synthetic, meaning a variety of bioproduction workflows are required. These workflows include some common use cases for osmolality testing, including the following:

  • 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.

Differentiation in use cases for osmolality testing are outlined below:

Monoclonal Antibody Vaccines

Osmolality testing should be performed on hybridoma cell media to ensure optimal antibody production rates.

  • The rate of antibody production in hybridoma cells depends on the osmolality of the medium in which the cells are grown.
  • The osmotic agent used to affect the osmolality levels also impacts Ab production.

Viral Vaccines

Osmolality testing should be performed on media solutions to optimize cell size and viral vector stability.

  • Osmotic pressure affects the size of the morphology of insect cells and viruses.
  • The osmolality of the media affects the composition of the lipid bilayer membrane of enveloped viruses. This directly impacts the vector stability.

mRNA and DNA Vaccines

Delivery systems and mechanisms should be tested for osmolality.

  • mRNA can be complexed with different agents (e.g. PEI) for delivery within the body. Osmolality impacts the stability of the complex of viral models.
  • Osmolality impacts the ability to penetrate the target cell membrane.

COVID-19 vaccine development often falls into these development categories. To better understand how osmolality testing benefits the production of therapies, visit the respective tabs: Protein Therapies, Cell Therapies, Gene Therapies, Oligonucleotides.

See all Advanced Osmometers >

An example of an accelerated mRNA vaccine production workflow is below:

Accelerated Development
(as little as 1 year)

References

Oligonucleotides

This novel field involves the use of antisense oligonucleotides (ASOs), aptamers, siRNAs, miRNAs and synthetic mRNAs to control the expression of genes that have been associated with diseases. Multiple Advanced Instruments customers within this field use osmometers to verify the concentration of the solutions carrying their precious products. Ultimately, the quality of the drug is dependent on the process controls implemented throughout the workflow. Below are some of the current uses for osmolality testing in this field:

Buffer QC

Osmolality specifications for buffers to preserve and protect the critical quality attributes of the product as it is being developed.

Final Product

Compendial release test needed to confirm the identity and concentration of the oligo product for safe use.

Because this is an emerging field, it comes with a number of development and application challenges:

  • Delivery of RNAs across the lipid bilayer and into cells
  • Immunogenicity once in the body
  • High rates of degradation of oligos by plasma and tissues

Drug delivery into the target cells requires the proper osmotic pressure, similar to the parameters around viral transfection in vector development. The optimal osmolality of the delivery complex (e.g. mRNA:PEI) should be determined and monitored during this process. This specification will provide repeatable successful delivery of the drug.

See all Advanced Osmometers >

References

Related Products

Comparison Guide

All models support

Pharmacopeia testing guidelines
New!

OsmoTECH® HT Automated Micro-Osmometer

OsmoTECH® PRO Multi-Sample Micro-Osmometer

OsmoTECH® XT Single-Sample Micro-Osmometer

OsmoTECH® Single-Sample Micro-Osmometer

Model 3250 Single-Sample Osmometer
Being discontinued Dec. 31, 2020
Workflow Features
Best for labs with daily sample processing needs of: >20/day >10/day 1-10/day 1-10/day 1-10/day
Sample volume 40 µL 30 µL 20 µL 20 µL 250 µL
Sample introduction 96 well plate Sample cup One-step direct One-step direct Sample cup
Operating range (mOsm/kg H2O) 0 – 2,000 mOsm/kg H2O 0 – 2,000 mOsm/kg H2O 0 – 4,000 mOsm/kg H2O 0 – 2,000 mOsm/kg H2O 0 – 4,000
Test time (seconds) 140 90 Less than 150 in low range, Less than 190 in high range 90 120
Multi-sample capacity
Automated cleaning between samples
Complex Matrices (High Concentrations, Sugars, & Proteins)
Integrated barcode scanner
Onboard Video Instructions
Multi-language touchscreen display
Compliance Support Features
Supports 21 CFR Part 11 & EU Annex 11 compliance
Electronic Signature (Review & Approve)
Supports Pharmacopeia testing guidelines compliance
Instrument Features
Username & Password Compatibility (With Active Directory)
Dot-matrix Printer
Data Management Features
Network Connection
Network share
Automatic backup
Control device remotely via OPC-UA
USB
Webserver for remote data viewing
Data Storage Capacity Unlimited Unlimited Unlimited Unlimited
Levels of users access 3 Levels 3 Levels 3 Levels 3 Levels
Data Format .csv & pdf .csv & pdf .csv & pdf .csv & pdf
Part # OSMOTECHHT OsmoTECHPRO OsmoTECHXT OsmoTECH 3250
Download Chart as a PDF

  1. Sold separately
  2. Single direction control only
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Educational Resources

Brochure

OsmoTECH® HT Automated Micro-Osmometer

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Q&A Resource

Data Integrity & Compliance – what every lab needs to know

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Poster

Product In Action – OsmoTECH® HT Automated Micro-Osmometer

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