OsmoTECH® PRO Multi-Sample Micro-Osmometer

Automation to fit your growing lab

The [OsmoTECH PRO] is great for accurate and precise osmolality, giving reliable and reproducible measurements.

Varun Khurana / Glaukos

Ease of Use, Accurate Osmolality Measurements, & Reliable Results

OsmoTECH PRO incorporates freezing point technology to test osmolality ensuring accurate and precise measurement of your essential parameter in process control and QC. It is enhanced with advanced data management options and can integrate seamlessly into high throughput workflows.

Highlighted features
  • Multi-sample Osmometer
  • Walk-away Testing
  • Reliable & Consistent Performance
  • Robust Data Integrity
  • Intuitive Interface
  • Pharmacopeia Compliance

Integrates Easily in Your Bioprocessing Workflow

Optimize your workflow with automated testing and cleaning while maintaining regulatory compliance (including 21 CFR part 11), and data management needs of busy bioprocessing and biomanufacturing labs.

The OsmoTECH PRO Multi-Sample Micro-Osmometer ensures your lab is more efficient, freeing you up to spend more time on what matters.

Industry Applications

In Biotech Labs

Maximize biologic yield, quality, and purity by optimizing and ensuring the quality and consistency of your buffers, media, product, excipients, and process parameters.

In Food & Beverage Labs

Boost efficiency, ensure product quality, and maintain process consistency with osmolality testing from formulation to release.

Product Features

  • 20- position sample turntable
  • Walk-away testing
  • Intuitive touch-screen interface for easy operation

  • Just a 30 μL sample volume

  • Freeze-point depression technology
  • 0 – 2000 mOsm/kg H2O

  • Bi-directional capability with OPC-UA to lab management and middleware software​

  • Integrated barcode scanner for sample identification and reduced transcription errors
  • Automatic, manual, synchronous back up
  • Complete time-stamped record of usage, role, and actions requiring reason for settings changes
  • Ability to annotate test results via the handy comments field

  • Active Directory/LDAP options minimize manual input and the risk of errors
  • Automatic or manual backups
  • 3 levels of user access
  • Automatic logout timer
  • Unlimited results and events storage

  • 21 CFR part 11 / EU Annex 11
    • e-Signature
    • Three level user access
    • Password protection
    • And more
  • GMP environment
  • Pharmacopeia osmolality testing guidelines

  • Network share (pdf & csv)
  • Open Protocol Communication (OPC-UA)
  • LIS (TCP/IP) Communication
  • Bi-directional data management capability with OPC-UA to connect lab management (LIMS) and middleware software
  • Active directory
  • USB download
  • Optional dot-matrix printer
Sample type Aqueous-based solution
Sample volume 30 ± 1 μL
Test time 90 seconds (typical) to test single sample 40 minutes (typical) to test 20 samples
Sample Capacity Multi sample
Resolution 1 mOsm/kg H2O
Range 0-2000 mOsm/kg H2O
Accuracy2 0-400 mOsm/kg H2O: mean value ± 3 mOsm/kg H2O from nominal value
400-2000 mOsm/kg H2O: mean value ± 0.75% from normal value
Within-run Repeatability2 0-400 mOsm/kg H2O: standard deviation ≤ 3 mOsm/kg H2O from nominal value
400-2000 mOsm/kg H2O: Coefficient of Variation ≤ 0.75%
Temperature effects3 Less than 1 mOsm/kg H2O per 5 °C (9 °F) ambient temperature change
Calibration 0*, 50, 850, and 2000* mOsm/kg H2O (* optional)
Supported Languages Simple Chinese, English, French, German, Italian, Japanese, Korean, 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) 39 cm x 25 cm x 46 cm (15.3” x 10” x 18”)
Net weight 13.2 kg (29 lbs.)
Shipping weight 17.7 kg (39 lbs.)
Warranty One-year limited warranty on workmanship and parts

Osmometer Calibration Standards and Reference Solutions

SK-TECHPROConvenience Kit (Includes: 3MA029, 3MA005, 3MA085, 3MA200, 3LA028, 222825, 222840, 202850, 240821)
3MA029Clinitrol™ 290 Reference Solution, 10×2 mL ampules
3MA0000 mOsm/kg H2O Calibration Standard, 10×2 mL ampules
3MA085850 mOsm/kg H2O Calibration Standard, 10×2 mL ampules
3MA2002000 mOsm/kg H2O Calibration Standard, 10×2 mL ampules
3LA028Osmolality Linearity Set 100-2,000 mOsm 5x2x5 mL
3MA002Osmolality Linearity Set, 100-2,000 mOsm 5x2x2 mL

Supplies

222825Disposable sample tubes
222840Probe wiper rings
202850Swab Cleaner Kit
240821Sampler Tips, 50/pkg
800097Pipette Tips (5-200 μL) Pack of 10

Accessories

135022Epson Dot Matrix Printer (sold-separately)
AN2TP5Dot Matrix Printer Paper
Osmolality Linearity Set

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

View Product
Osmometer Calibration Standards

Available from 0-4000 mOsm/kg H2O 10 x 2 mL Ampules

View Product
Protinol™ Protein-Based Controls

Protinol 3-Level Osmometer Control 3x3x3 mL

View Product

Biotech Services

Get the best performance from your osmometer from the people who designed and built it. We provide a range of services and service plans to meet the different needs of our customers. Our certified Field Service Engineers provide on-site professional support for the installation, training, validation, and maintenance of your osmometers.

Learn more

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 our innovative osmometers, 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 of our Osmometers

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

  • Amaral AI et al. Improving retroviral vectors production: Role of carbon sources in lipid biosynthesis. J Biotechnol. 2008 Nov 25;138(3-4):57-66.
  • Burger C et al. Systemic Mannitol-Induced Hyperosmolality Amplifies rAAV2-Mediated Striatal Transduction to a Greater Extent Than Local Co-infusion. Mol Ther. 2005 Feb;11(2):327-31.
  • Ferreira TB et al. Two different serum-free media and osmolality effect upon human 293 cell growth and adenovirus production. Biotechnol Lett. 2005 Nov;27(22):1809-13.
  • Rodrigues AF et al. Production of Retroviral and Lentiviral Gene Therapy Vectors: Challenges in the Manufacturing of Lipid Enveloped Virus. In Viral Gene Therapy, ed. Ke Xu. London:IntechOpen Limited. 2011.
  • Cordova A et al. Osmotic Shock and the Strength of Viral Capsids. Biophys J. 2003 Jul;85(1):70-4.
  • Coroadinha AS. Effect of Osmotic Pressure on the Production of Retroviral Vectors: Enhancement in Vector Stability. Biotechnol Bioeng. 2006 Jun 5;94(2):322-9.

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 our innovative osmometers, 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 of our Bioprocessing Osmometers

Application Notes

References

  • Casula E et al. Osmotic behaviour of human mesenchymal stem cells: Implications for cryopreservation. PLoS One. 2017 Sep 8;12(9):e0184180.
  • Li Y and Ma T. Bioprocessing of Cryopreservation for Large-Scale Banking of Human Pluripotent Stem Cells. Biores Open Access. 2012 Oct;1(5):205-14.
  • Petrenko Y et al. Clinically Relevant Solution for the Hypothermic Storage and Transportation of Human Multipotent Mesenchymal Stromal Cells. Stem Cells Int. 2019 Jan 20;2019:5909524.
  • Rafiq QA et al. The role of biopreservation in cell and gene therapy bioprocessing. Cell & Gene Therapy Insights. 2017. ISSN: 2059-7800. 335-344.
  • Bohnenkamp H et al. Bioprocess development for the cultivation of human T-lymphocytes in a clinical scale. Cytotechnology. 2002 Jan;38(1-3):135-45.
  • Nie Y et al. Scalable Passaging of Adherent Human Pluripotent Stem Cells. PLoS One. 2014 Jan 30;9(1):e88012.
  • Potočar U et al. Adipose-Derived Stem Cells Respond to Increased Osmolarities. PLoS One. 2016 Oct 5;11(10):e0163870.

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 our innovative osmometers, 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 of our Osmometers

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

  • Amaral AI et al. Improving retroviral vectors production: Role of carbon sources in lipid biosynthesis. J Biotechnol. 2008 Nov 25;138(3-4):57-66.
  • Burger C et al. Systemic Mannitol-Induced Hyperosmolality Amplifies rAAV2-Mediated Striatal Transduction to a Greater Extent Than Local Co-infusion. Mol Ther. 2005 Feb;11(2):327-31.
  • Ferreira TB et al. Two different serum-free media and osmolality effect upon human 293 cell growth and adenovirus production. Biotechnol Lett. 2005 Nov;27(22):1809-13.
  • Rodrigues AF et al. Production of Retroviral and Lentiviral Gene Therapy Vectors: Challenges in the Manufacturing of Lipid Enveloped Virus. In Viral Gene Therapy, ed. Ke Xu. London:IntechOpen Limited. 2011.
  • Cordova A et al. Osmotic Shock and the Strength of Viral Capsids. Biophys J. 2003 Jul;85(1):70-4.
  • Coroadinha AS. Effect of Osmotic Pressure on the Production of Retroviral Vectors: Enhancement in Vector Stability. Biotechnol Bioeng. 2006 Jun 5;94(2):322-9.

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 of our 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.

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.

  • 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.

  • 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.

  • 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.

References

  • Hasan et al. Osmolytes in vaccine production, flocculation and storage: a critical review. I. 2019; 15(2): 514–525.
  • Coroadinha, AS et al. Effect of osmotic pressure on the production of retroviral vectors: Enhancement in vector stability. Biotechnol Bioeng 2006; 94(2):322-9.
  • Tanja A. Grein, Tobias Weidner and Peter Czermak. Concepts for the Production of Viruses and Viral Vectors in Cell Cultures. New Insights into Cell Culture Technology, pp.173-191.

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 of our Osmometers

References

  • Pardi, N., Hogan, M., Porter, F. et al. mRNA vaccines — a new era in vaccinology. Nat Rev Drug Discov 17, 261–279 (2018)
  • Poveda C, Biter AB, Bottazzi ME, Strych U. Establishing Preferred Product Characterization for the Evaluation of RNA Vaccine Antigens. Vaccines (Basel). 2019 Sep 27;7(4). pii: E131.
All models support
Pharmacopeia testing guidelines
New!
Being discontinued Dec. 31, 2020
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
Supports 21 CFR Part 11 & EU Annex 11 compliance
Electronic Signature (Review & Approve)
Supports Pharmacopeia testing guidelines compliance
Username & Password Compatibility (With Active Directory)
Dot-matrix Printer
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
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Application Note

Improving Titer, Quality And Efficiency Of AAV Manufacturing And Production By Optimizing Osmolality

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Application Note

How Labs Achieve Data Integrity

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Webinar

Examining The Use Of Osmolality Within Viral Vector Manufacturing

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Knowledge Center

Osmometers – Principle, Types & Uses

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Knowledge Center

What Is Osmolality?

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Knowledge Center

Freezing Point Depression Theory

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What our customers say

We had a demo of the [OsmoTECH PRO] instrument after seeing it at BPI East. The sales managers were prompt in setting up a lunch and learn. The instrument itself was very easy to run samples on and allowed for true load and walk away functionality. The sales managers were thorough professionals, waiting for our PO to go through and working with us to ensure we received the item within a week of ordering. It has the ability to run 20 samples at a time and is great value for the money spent.

Kanaka Bhere

Boehringer Ingelheim Animal Health

The [OsmoTECH PRO] instrument is extremely effective, easy to set up and validate, gives quick results and is extremely accurate.

David Longino

Aspek Pak

The [OsmoTECH PRO] is great for accurate and precise osmolality, giving reliable and reproducible measurements.

Varun Khurana

Glaukos

[The OsmoTECH PRO] instrument is simple to operate with minimal consumables.

Greg Hautke

Baxter Healthcare

This [OsmoTECH PRO] osmometer is an accurate and convenient tool for the needs of our lab. Our lab works in the developmental stage of pharmaceuticals, and requires quick, precise bursts of osmolality checking for QC - and this instrument (with a load capacity of 20 samples) takes care of those needs. With developmental drugs, limited sample volume is often an issue - this instrument only needs 30uL (and takes ~90 seconds a measurement).

Sasha Sheptovitsky

Alexion Pharmaceuticals

Osmolality measurements are easy and reliable with this [OsmoTECH PRO] instrument.

Kevin Kent

Boehringer-ingelheim

[The OsmoTECH PRO is] very easy to use for all technicians in a quality control lab. Small sample size. Friendly technicians that explained how to use the product very well.

Cathy Gladkowski

Biologos LLC

[The OsmoTECH PRO is] very easy to use due to short analysis time and sample preparation.

Karthik Venkatachalam

Pfizer

[The OsmoTECH PRO is a] great system for multiple sample testing. Very straightforward and easy to use.

Bobby Grigoropoulos

Fresenius Kabi USA

The [OsmoTECH PRO] is very easy to use. Allows my lab to update a 20+ year old instrument, also from Advanced.

Walter Wasylenko

Baxter Healthcare Corporation

[The OsmoTECH PRO is an] excellent product and extremely efficient! Easy to clean and maintain. Excellent customer support and allows increased in-process testing capabilities.

Seth Rindner

Biologos LLC

The OsmoTECH PRO is working pretty well so far! ... As far as reproducibility, data integrity, ease of use etc. I think it is a very good upgrade for us! On the whole we’re quite happy, I'd recommend this device to a colleague looking for a new high throughput osmometer.

Sean Clements

Takeda

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Austria: +49 695 0606 800
Belgium: +31 6 899 25902
France: +33 456 681 861
Germany: +49 695 0606 800
The Netherlands: +31 6 899 25902
United Kingdom: +44 740 890 1366

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