OsmoTECH® PRO Multi-Sample Micro-Osmometer | AI
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OsmoTECH® PRO Multi-Sample Micro-Osmometer

NOMINEE – SelectScience Scientists’ Choice Awards 2020 “Best New Lab Product”

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.

Highlighted features:
  • Multi-sample osmometer
  • Gold standard freezing point technology
  • Robust data integrity
  • Supports 21 CFR part 11, GMP, and EU Annex 11 compliance
  • Meets Pharmacopeia osmolality testing guidelines

Overview

Industry Applications

biotech

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.

food

IN FOOD & BEVERAGE LABS

Maintain efficiency while ensuring product quality and process consistency with osmolality testing from formulation to release.

PRODUCT FEATURES

EFFORTLESSLY RUN MULTIPLE SAMPLES

A 20-position sample turntable enables walk-away testing.

INTUITIVE TOUCH-SCREEN INTERFACE

The menu-driven operating system, multi-language capability and touchscreen graphic interface all make for easy operation.

SMALL SAMPLE REQUIREMENT

Just a 30 μL sample volume is needed, facilitating sample-limited applications.

INDUSTRY LEADING ACCURACY AND PRECISION

OsmoTECH PRO utilizes the gold-standard testing method—freezing point depression—to accurately and precisely determine osmolality.

FACTORY CALIBRATED

The system is factory calibrated and ready to test. Recalibration is only required if quality control is out of specification, or after maintenance.

MAINTAIN TRACEABILITY

The integrated barcode scanner simplifies sample identification and reduces transcription errors.

PRESERVE YOUR AUDIT TRAIL

Get a complete time-stamped record of usage, role, and actions requiring reason for settings changes, as well as the unique ability to annotate test results via the handy comments field.

PROTECT YOUR DATA

Active Directory/LDAP options minimize manual input and the risk of errors. Automatic or manual backups, three levels of user access, and an automatic logout timer keep your data safe during idling. Plus, you get unlimited results and events storage

EASILY INTEGRATE DATA MANAGEMENT INTO YOUR ESTABLISHED WORKFLOW

Quickly save data to a network database, USB device, or the embedded Web server and eliminate the need to manually manage date and time by synchronizing with network time.

EXPORT DATA WITH EASE

Move data using Open Protocol Communication (OPC), USB download, Network share, IS (TCP/IP communication), and an Optional DOT-MATRIX PRINTER.

BACKED BY COMPREHENSIVE SUPPORT

You can purchase any Advanced Instruments osmometer with complete confidence as every instrument is backed by a knowledgeable, experienced, and responsive customer support team.

Technical Specifications

Sample typeAqueous-based solution
Sample volume30 ± 1 μL
Test time90 seconds (typical) to test single sample 40 minutes (typical) to test 20 samples
Sample CapacityMulti sample
Resolution1 mOsm/kg H2O
Range0-2000 mOsm/kg H2O
Accuracy20-400 mOsm/kg H2O: mean value ± 3 mOsm/kg H2O from nominal value 400-2000 mOsm/kg H2O: mean value ± 3 0.75% from normal value
Within-run Repeatability20-400 mOsm/kg H2O: standard deviation ≤ 3 mOsm/kg H2O from nominal value 400-2000 mOsm/kg H2O: Coefficient of Variation ≤ 0.75%
Temperature effects3Less than 1 mOsm/kg H2O per 5°C (9°F) ambient temperature change
Calibration0*, 50, 850, and 2000* mOsm/kg H2O (* optional)
Supported LanguagesSimple Chinese, English, French, German, Italian, Japanese, Korean, Russian, Spanish, Turkish
Storage temperature-20°C to +45°C (-4°F to +113°F)
Electrical voltage100 to 240 VAC (50/60 Hz)
Power consumption60 Watts
Dimensions (D x W x H)39 cm x 25 cm x 46 cm (15.3” x 10” x 18”)
Net weight13.2 kg (29 lbs.)
Shipping weight17.7 kg (39 lbs.)
WarrantyOne-year limited warranty on workmanship and parts

Associated Products

Osmometer Calibration Standards

50, 850 & 2000 mOsm
10 x 2mL Ampules

Osmolality Linearity Set

100-2,000 mOsm
5x 2x 5mL Ampules

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 AmpulesView
3MA0000 mOsm Calibration Standard, 10×2 mL AmpulesView
3MA085850 mOsm Calibration Standard, 10×2 mL AmpulesView
3MA2002000 mOsm Calibration Standard, 10×2 mL AmpulesView
3LA028Osmolality Linearity Set 100-2,000 mOsm 5x2x5 mLView

Supplies

222825Disposable sample tubes
222840Probe wiper rings
202850Swab Cleaner Kit
240821Sampler Tips, 50/pkg

Accessories

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

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.

Applications

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.

Upcoming Trade Shows

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 your transduction mechanics being optimized?

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 >

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.

Upcoming Trade Shows

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 >

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.

Upcoming Trade Shows

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].

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

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

Comparison Guide

All models support
  • Pharmacopeia testing guidelines

Workflow Features
Best for labs with daily sample processing needs of:>10/day>10/day1-10/day1-10/day
Sample volume100 µL30 µL20 µL250 µL
Sample introductionAutomated liquid handling sample cup (automated)Sample cupOne-step directSample cup
Operating range (mOsm/kg H2O)0 – 4,0000 – 2,0000 – 2,0000 – 4,000
Test time (seconds)1809090120
Compliance Support Features
Supports 21 CFR Part 11 & EU Annex 11 compliance
Supports Pharmacopeia testing guidelines compliance
Instrument Features
Integrated barcode scanner
Printer
Multi-language touchscreen display
User name & password compatibility
Multi-sample capacity
Automated cleaning between samples
Automated sample pipetting
Temperature control methodDry cooling (No heat transfer fluid)Dry cooling (No heat transfer fluid)Dry cooling (No heat transfer fluid)Heat-transfer fluid
Data Management Features
TCP/IP
USB
Webserver
OPC-UA, Network share,
Database backup
DTE RS-232, Barcode port
Part #A2OOsmoTECHPROOsmoTECH3250

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Educational Resources

Brochure

OsmoTECH® PRO Multi-Sample Micro-Osmometer

Q&A Resource

Data Integrity & Compliance – what every lab needs to know

Research Paper

Osmolality as a predictor for model-based real-time monitoring of concentration in protein chromatography

We are open and continue to provide essential lab supplies during the COVID-19 pandemic. Answers to your FAQ’s can be found here.

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