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OsmoTECH® XT Single-Sample Micro-Osmometer

Best-in-class osmolality performance
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In the beginning, you never know which kind of samples you’re going to test, and the [OsmoTECH XT] osmometer offers an amazing range of osmolality testing: from 0 to 4000 mOsm/kg H2O.

Kayla Pasake / The Center for Breakthrough Medicines

Best-in-class osmolality performance, designed with you in mind​.

OsmoTECH XT empowers labs with accurate and precise osmolality analysis for a wide range of liquid samples across bioprocessing and cell & gene therapy workflows.

Streamline your osmolality workflow with a user-friendly interface and ensure robust data integrity with compliance features to match any digital environment.

Highlighted features
  • Widest Range Osmolality Testing
  • Small Sample Size                 ​
  • Intelligent Freezing Technology
  • Intuitive Interface
  • 21 CFR Part 11, GMP, EU Annex 11 Compliance
  • Pharmacopeia Compliance

Confidence in your process and quality control

Osmolality testing with OsmoTECH XT ensures reliable and robust analysis providing you with confidence in the development of a quality therapeutic. The OsmoTECH XT unlocks the next generation of freezing point depression testing to determine the osmolality of even the most complex samples. Engineered in collaboration with scientists across bioprocessing workflows to address the unique user and data security pain points found throughout every stage of the bioprocessing workflow.

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

  • Only 20 μL sample volume with optimized cooling engine
  • Measure even the most complex samples with more accuracy and precision

  • Measure high concentrated solutions such as proteins and sugars
  • Remove dilutions

  • 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

  • Positive displacement sampler
  • Aspirate highly viscous sample types (hyaluronate, cryopreservatives, etc.)

  • 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

  • Large touchscreen

  • Integrated consumable shelf
  • Clean-room friendly consumables
Sample type Aqueous-based solution
Sample volume 20 ± 1 μL
Test time ≤150 seconds in low range; ≤190 seconds in high range
Sample Capacity Single sample
Resolution 1 mOsm/kg H2O
Range 0-4000 mOsm/kg H2O
Accuracy ±2 mOsm/kg H2O from nominal value between 0 and 400 mOsm/kg H2O (1 SD)

±0.5% from nominal value between 400 and less than 1500 mOsm/kg H2O (1 SD)

±1% from nominal value from 1500 to 4000 mOsm/kg H2O (1 SD)
Within-run Repeatability (AI Standards and Reference Solutions) Standard deviation ≤ 2 mOsm/kg H2O between 0 and 400 mOsm/kg H2O

Coefficient of variation ≤ 0.5% between 400 and less than 1500 mOsm/kg H2O

Coefficient of variation ≤ 1% from 1500 to 4000 mOsm/kg H2O
Supported Languages English, Simplified Chinese, 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) Not including test kit: 15″ x 14″ x 10″ (38 cm x 36 cm x 25 cm)

Including test kit: 15″ x 14″ x 11.5″ (38 cm x 36 cm x 38 cm)
Net weight 5.9 kg (12.9 lbs.)
Shipping weight 11.4 kg (25 lbs.)
Warranty One-year limited warranty on workmanship and parts
  1. Subject to change

Osmometer Calibration Standards and Reference Solutions

SK-TECHXTOsmoTECH XT Convenience Kit (Includes: XT100, 3LA051, 3MA029, 3LA151, 3LA301, 3LA028, 3MA000, 3MA400)View
3MA0000 mOsm/kg H2O Calibration Standard, 10×2 mL ampulesView
3MA029Clinitrol™ 290 Reference Solution, 10×2 mL ampulesView
3LA051500 mOsm/kg H2O Calibration Standard, 10×5 mL ampulesView
3LA1511500 mOsm/kg H2O Calibration Standard, 10×5 mL ampulesView
3LA3013000 mOsm/kg H2O Calibration Standard, 10×5 mL ampulesView
3MA4004000 mOsm Calibration Standard, 10×2 mL AmpulesView
3LA028Osmolality Linearity Set 100-2,000 mOsm 5x2x5 mLView
3MA002Osmolality Linearity Set, 0-2,000 mOsm 5x2x2 mLView

Supplies

XT100Micro-Sample Test Kit: 1 box of 100 chamber cleaners, 100 sampler tips, 1 plunger wireView
3M0828APlunger Wire, 1 per order (Replaces 3M0828- Plunger Wires, set of 2. Please note: A plunger wire is included in every 133800, TECH250, and XT100 Micro-Sample Test Kit box.)View
3M0825Ease-Eject 20-Microliter SamplerView

Accessories

135022_EUEpson Dot Matrix Printer (sold-separately). For CE marked printers - For all of EU & UK onlyView
135022_EX-EUEpson Dot Matrix Printer (sold-separately). For all other countries US, Canada, S.Korea, India, Australia etc.View
AN2TP5Dot Matrix Printer PaperView
Clinitrol™ 290 Reference Solution

10 x 2 mL Ampules

View Product
Osmometer Calibration Standards

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

View Product
Osmolality Linearity Set

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

  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

  • 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.

See all of Our Osmometers

 

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.
  • Pardi, N., Hogan, M., Porter, F. et al. mRNA vaccines — a new era in vaccinology. Nat Rev Drug Discov 17, 261–279 (2018).
  • Choi H-J, Song J-M, Bondy BJ, Compans, RW, Kang S-M, Prausnitz MR (2015). Effect of Osmotic Pressure on the Stability of Whole Inactivated Influenza Vaccine for Coating on Microneedles. PLoS ONE 10(7): e0134431.
  • Rosinski, M. Osmolarity effects on observed insect cell size after baculovirus infection are avoided using growth medium for sample dilution. Biotechnol Prog. 2000 Sep-Oct;16(5):782-5.
  • Sonia Gutiérrez-Granados, Laura Cervera, Amine A. Kamen & Francesc Gòdia (2018): Advancements in mammalian cell transient gene expression (TGE) technology for accelerated production of biologics, Critical Reviews in Biotechnology.

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!
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
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
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Case Study

Osmolality: A Powerful Tool in Bioprocessing

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Application Note

A Perspective On Various Use Cases Of Osmolality In Quality Control

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Application Note

Osmolality Monitoring For UF/DF And CEX Capture Of MAbs From Mammalian Cell Cultures

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Application Note

8 Ways That Osmolality Testing Improves Cell And Gene Therapy Processing

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Application Note

Data Integrity And Compliance: What Every Lab Should Know

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Application Note

Reliable Osmolality Testing Of High Concentration MAb Formulations

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What our customers say

[The OsmoTECH XT is] easy to use, reliable and self-navigating options menu.

Alexander Shapiro

Precision NanoSystems

[The OsmoTECH XT is a] robust and versatile instrument that meets all of our osmolality needs!

Will Heaton

DiscGenics

The Osmotech XT provides data integrity compliance, ensuring the reliability and accuracy of our results. The ease of use, great value for money, and exceptional after-sales service have significantly improved our processes. The support team is always available for any questions, provided on-site training, and continues to assist with upgrades as needed. I highly recommend this instrument to anyone in the field.

Caitlin Wint

Validation Manager at cutting edge cell therapy developer

In the beginning, you never know which kind of samples you’re going to test, and the [OsmoTECH XT] osmometer offers an amazing range of osmolality testing: from 0 to 4000 mOsm/kg H2O.

Kayla Pasake

The Center for Breakthrough Medicines

Osmolality testing is crucial for process development, analytical development and GMP testing. We need to meet the regulatory requirements [with the OsmoTECH XT] for the product to be released to the market or to be released to go to a patient.

Kayla Pasake

The Center for Breakthrough Medicines

Request Pricing

For a quotation, to arrange a demonstration, or for more information please contact us by phone or complete the form.

Austria: +49 695 0606 800
Belgium: +31 6 899 10929
France: +33 456 681 861
Germany: +49 695 0606 800
The Netherlands: +31 6 899 10929
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Austria: +49 695 0606 800
Belgium: +31 6 899 10929
France: +33 456 681 861
Germany: +49 695 0606 800
The Netherlands: +31 6 899 10929
United Kingdom: +44 140 321 0400

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Austria: +49 695 0606 800
Belgium: +31 6 899 10929
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Germany: +49 695 0606 800
The Netherlands: +31 6 899 10929
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Austria: +49 695 0606 800
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