Bioprocessing Industry

Final Product QC

Ensure the quality and safety of your drug product for patients, and minimize the risk of impurities.

Pharmaceutical Quality Control

Any substance entering the body must be physiologically isotonic. Osmolality testing has long been considered a compendial measurement for pharmaceutical quality control and the release of biological drugs (FDA).

Products with an unexpected osmolality can produce negative reactions when introduced into human tissue, causing side effects such as pain at the injection site.

Media Preparation Quality Control

It’s increasingly common for drug manufacturers to outsource the media and components used in manufacturing, making Quality Control (QC) of culture media even more critical for ensuring the quality of processes.

To ensure a proper environment for cell line development, each batch of media must meet predetermined osmolality specifications with the hope of maximizing yield.

Liquid Handling Quality Control

Industry regulations provide confidence in quality, safety, and efficacy of products on the market. The production of any therapeutic must comply with 21 CFR Part 11, GLP, GMP and other ISO standards. 

We support your lab with liquid volume verification technology, training and services to ensure regulatory compliance of your automated liquid handlers, pipettes, and personnel.  

 

Ensure the Quality of Media to Maximize Yields and Provide High-quality Products for Patients

Quality Control is essential to measure that the osmolality of drug products is within set standards throughout manufacturing processes. It ensures biopharmaceutical products are consistently produced to a predetermined yield, purity, and quality.

Formulation Development

Optimize formulation concentration and stability for high yields in manufacturing.

Final Formulation

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

Filtration and Fill

Key compendial release specification to confirm product stability.

Access our Popular Educational Resources

Learn more about how to utilize osmolality to help ensure Quality Control of your drug product - check out our comprehensive educational resources.

Bioprocessing Case Study

SEKISUI XenoTech ensures quality and productivity with the MVS

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Bioprocessing Case Study

Osmolality: A Powerful Tool in Bioprocessing

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Bioprocessing Case Study

Takeda streamlines assay transfer and troubleshooting with the Artel MVS

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Bioprocessing App Note

A Perspective on Various Use Cases of Osmolality in Quality Control

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Bioprocessing App Note

White Paper: Process Optimization for Assays: A Framework for Controlling Variability and Optimizing Assay Performance

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Bioprocessing App Note

How Labs Achieve Data Integrity

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Bioprocessing Webinar

Osmolality for QC of cell therapy cryo-preservative formulation

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Bioprocessing Webinar

Upstream Applications of Osmolality Testing in Cell & Gene Therapy Processes

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Bioprocessing Webinar

Managing Quality and Compliance Operations in an Accelerating Scientific Landscape

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Bioprocessing Posters

Osmolality as a concentration measurement method for key buffers in bioprocessing

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Bioprocessing Posters

Pipetting Viscous Solutions

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Bioprocessing Posters

Osmolality as a valuable tool in formulation studies for advanced therapies

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Bioprocessing Knowledge Center

Data Integrity

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Bioprocessing Knowledge Center

Automated Liquid Handlers as Sources of Error

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Bioprocessing Knowledge Center

Understanding Precision, Trueness and Accuracy

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Associated Products

Bioprocessing Services

Get the best performance from your instruments from the experts who designed them. We provide a range of services and service plans to meet your specific needs.

Our certified Field Service Engineers provide on-site, professional installation, training, validation, and system maintenance support.

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This [OsmoTECH] instrument was a dream come true. The administrator can lock down features and dictate what users can and cannot do. Very easy to use and extremely reliable instrument.

Troy Franz

Paragon Bioservices

The Artel MVS simplifies fluid verification of all automated liquid handlers and multichannel pipettes. The system is fast, calculates all plate and well statistics (Relative Inaccuracy, Coefficient of Variation, Standard Deviation and Mean) and it is simple to set up and use. For all of its capabilities and low-cost point...the MVS is one of the best value purchases I have ever made for my lab.

Mark Orlowski

Pfizer

The best part of the [OsmoTECH] instrument is it gives accurate and reproducible results for any solution and most importantly in less than a minute you have the results.

Brijeshkumar Pandya

Nivagen Pharmaceuticals Inc.

The Artel MVS makes it so easy to do a monthly verification that the 96 channel CORE head on my Hamilton Vantage is dispensing the correct volumes. Doing the confirmation gravimetrically would be so time consuming, but using the Artel dyes and the MVS makes it something one person can do in a single morning. The software is easy to use, and the instrument has not had any maintenance issues.

Katherine Schneider

Pfizer

[The OsmoTECH] achieves high quality and reproducible results. Easy instrument to use and well-presented software.

Claudia Chadford

Touchlight Genetics

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

Greg Hautke

Baxter Healthcare

We use the PCS pipette calibration system. It has always been super reliable and accurate, and we have never had a single issue in the 8 years I have worked with it. The kits containing the solutions for the PCS are customizable, so you don't have to buy solutions you don't need. We do performance checks on our pipettes on a daily basis, so we could not live without it! It makes our jobs so much easier too!

Joan Kozlowski

Fresenius Kabi

The Artel PCS makes checking the pipetting proficiency of new hires quick and easy. It's also great for checking pipettes that may not be functioning properly.

Eric M

Sanofi

The Artel MVS has been a huge help for our lab in validating volumes on new automated liquid handlers. Always gives consistent results, easy to use, software is extremely straightforward, and any time we have an issue, it's super easy to get help from the Artel team. Thank you!

Leah Chong

Invitae

The MVS system is extremely useful for periodic performance QC testing of high-throughput liquid handlers, high-throughput liquid handler calibration, and various liquid handler/single channel pipette tip type/lot QC. The MVS system requires minimal maintenance and MVS manager software is intuitive to use and flexible to set up various plate layouts to meet user’s need. The customer service is very responsive and helpful. They provide a notification for calibrator plate re-certification annually ...

Hyun-Wu Lee

Canada's Michael Smith Genome Sciences Centre

The [Artel MVS] product is accurate and reliable. With the addition of the pre-owned models of MVS readers, it also becomes affordable. The expansion of the dye solutions to include MasterMix and Serum along with their original aqueous offering makes Artel a definitive liquid class setup solution. The FSE performing setup and the account manager were on-time, responsive, and supportive during install and (most importantly) afterwards.

Kevin Kim

Avellino Labs

The Artel application scientist is easy to work with, knowledgeable about interpreting test data and giving advice, and flexible to help onsite if needed. I would recommend the Artel MVS because it saves time and material cost. Most important is having a standard method to calibrate different pipettes and optimize liquid class on automated liquid handlers while managing the sources of variability systematically.

Michelle Mak

10x Genomics

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

Alexander Shapiro

Precision NanoSystems

The [OsmoTECH] is highly effective and obtained results are of high quality. With this instrument I can develop my formulation for meeting the osmolality criteria for drug products.

Siva Bingi

Intas Pharmaceuticals

[The OsmoTECH is] easy to use and robust piece of equipment that met all our user and regulatory requirements. The hardware is sleek, efficient and easy to use. The integrated software has built in data integrity controls and is thoroughly tested through validation test scripts / reports.

J. Lacey

Replimune

The Artel PCS fulfills our requirements on ISO compliant pipette calibration and testing. Results are reproducible and variance is lower than in manual process. Personnel is easily trained on the device. Process is faster than manual process.

Andreas Heider

Axolabs GmbH

The MVS system is fairly intuitive to use. Not only can we use this for our internal automated liquid handler volume verification, tip test and calibration work, we have been using the system to offer external volume verification service to our collaborators. The system is very durable without significant issues and easy to maintain. MVS reagent orders are always processed and delivered in a timely manner. Our regional specialist periodically checks in to ask if the system is working as expected.

Hyun-Wu Lee

Canada's Michael Smith Genome Sciences Centre

The [Artel MVS] is easy to use, gives accurate and reliable results. It's a great way to quickly determine the functioning of the automation systems that we install and maintain.

Thobias Haakman

Beckman Coulter

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

Walter Wasylenko

Baxter Healthcare Corporation

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

Will Heaton

DiscGenics

The MVS has been a great asset to my team's measurement capabilities for the past 10 years. We just recently purchased the newest version of the MVS. We had a lengthy delay in our PO process and Nate the Artel Account manager has been very understanding and has helped us the entire way. The system makes accuracy and precision testing for liquid dispensing very efficient. When we need additional supplies or support questions the Artel staff has always been top tier. We plan to try the new Artelware software and move away from the older Data manger software.

Dan Baumgartner

Metrologist, Bayer

Once we brought [the Artel MVS] into the lab, we realized we could push to small volumes. We typically work beyond the liquid handler’s specifications, and we can do this because we have Artel to verify their performance.

Robert Grbac

SEKISUI XenoTech

The Artel MVS System has greatly improved our laboratory quality processes, not only streamlining instrument qualifications but accelerating verification and validations.

Chris Trefill

SummerBio

We rely on the MVS for verifications and liquid class development and optimization…

Thai Truong

Janssen R&D

The [Artel MVS] simplified and streamlined our QC process…

Natalie Grow

Bristol-Meyers Squibb

The MVS system has been vital to our lab operations.

Hyun-Wu Lee

Canada's Michael Smith Genome Sciences Centre

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

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If you have any questions about Final Product QC or are interested in learning more, please ask!

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Shweta Nair

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Sr Product Manager, Biopharma