Bioprocessing Industry

Cell Therapies

Accelerate cell based workflows for quicker cell therapy process development

The Drivers for Change in hiPSC Single Cell Cloning for Master Cell Banks

hiPSC (human induced pluripotent stem cell) are a source of potential cellular immunotherapies. In the commercial setting, hiPSCs start as single cells and are expanded into a Master Cell Bank (MCB) to create a therapeutic cell population.

Cell therapy development workflows are time consuming and often present challenges to auditing and quality control. The production of MCBs must adhere to cGMP (Clinical Good Manufacturing Process) conditions, aiming to optimize cell growth while ensuring their stability and functionality for safe and effective transplantation into patients. FDA requires a comprehensive package of documentation to assure the cell colony was derived from the single cell which is captured throughout the process.

Accelerate Your GMP Cell Line Development Workflow and Be IND-ready

From process development to clinical manufacturing our Solentim portfolio includes GMP-compatible solutions to accelerate your workflow with:

  • Automated, gentle single cell seeding.
  • Clonal assurance with superior high-quality whole well imaging.
  • Time-saving Artificial Intelligence-driven cell detection.
  • Dynamic Clonality Report, for IND submission readiness.
  • Robust data analysis with complete cell audit trail.
  • iPSC matrices to increase cell survival and outgrowth without coating plates.
  • 21 CFR Part 11 compliance for data integrity.

 

 

Optimize Your Cell Line Development

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.

Adding a simple 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 feed and media preparation.

Miniaturized Assays and Low Volumes Leave No Room for Error

The research and development phase of cell therapy is critical. Laboratories must ensure the efficacy, potency, and safety of new treatments. Whether you are working with scarce patient-derived samples or dealing with low yields on your viral capsid harvest, you need your assays to work. Under-dispensing can cause assay failure while over dispensing can drive up cost by being unnecessarily wasteful. 

Ensuring liquid handling performance verification is critical to meet this need. With our technology and services, you can take the liquid handling errors out of the equation! Liquid volume verification can help you ensure that the pipetted volumes are correct (even for volumes as low as 0.1uL) when you are prepping samples for your critical assays, such as qPCR, RT-PCR, NGS, ELISA, or HPLC. 

Optimize Your Cell Therapy Workflow While Maximizing Yields and Providing High Quality Therapies

Ensure stem cells are at the highest viability and product quality levels throughout the entire cell therapy workflow from culture and processing all the way to fill and finish.

Popular Educational Resources

Learn more about how our technologies can be utilized to help accelerate your cell therapy workflow by checking out our educational resources below

Bioprocessing Case Study

Doubling the Speed of Cell Line Development in a Large Pharmaceutical Company

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Bioprocessing Case Study

Reducing the timeline by 30% to produce a monoclonal cell line expressing a clinical candidate bi-specific antibody

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Bioprocessing Case Study

Osmolality: A Powerful Tool in Bioprocessing

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Bioprocessing App Note

8 Ways That Osmolality Testing Improves Cell and Gene Therapy Processing

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Bioprocessing App Note

Development of a Highly Efficient, Documented Workflow for Making Clonal Cell Banks of Gene-Edited iPSCs

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Bioprocessing App Note

High efficiency single cell cloning of iPSCs using combination of MatriClone™ and VIPS®

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Bioprocessing Webinar

New Assurance Rich Clonality Based Workflows for Commercial Cell and Gene Therapy Laboratories

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Bioprocessing Webinar

The Future of Osmolality Testing Within Cell and Gene Therapy

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Bioprocessing Webinar

Osmolality, a Critical Quality Attribute for Cell Line Development and Cell Therapy

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Bioprocessing Posters

Improving Cell Line Development Processes Through Accurate, Low Volume and Rapid Automated Cell Counting and Viability on the ICON™ Instrument Using STUDIUS™ Data Management Software

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Bioprocessing Posters

Assurance of Monoclonality of Recombinant CHO Cell Lines using High Resolution Imaging

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Bioprocessing Posters

Proof that can travel – Documented clonality report for regulatory submission

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Bioprocessing Knowledge Center

Cell Line Development for Biotherapeutics

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Bioprocessing Knowledge Center

Assurance of Clonality

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Bioprocessing Knowledge Center

Data Integrity

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Associated Products

Bioprocessing Services

Get the best performance from your instruments from the people who designed and built them. 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 Advanced Instruments products.

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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 [Insti-reagents] product worked as expected and was very useful in outgrowing clones from a single cell to shaking cultures. Highly recommend.

Nikita Gupta

Ginkgo Bioworks

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.

Marc 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

The [Insti-reagents] product worked as expected and was very useful in outgrowing clones from a single cell to shaking cultures. Highly recommend.

Nikita Gupta

Ginkgo Bioworks

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

[With the VIPS PRO], we can trace back the data to the single cell, select from our top 48 cell lines, and report all the information – our proof of monoclonality is already in there, and that’s really nice.

Jolanda Gerritsen

Genmab

The Enhanced Clonality Reports easily generated by the VIPS/Cell Metric software allows us to track both cells and potential debris from first inception of the single cell in the well, to full-grown colonies enabling us to provide our customers with full traceability and audit trail of each cell line we produce for them with a single, well-crafted document.

Camile Evenou

Celonic AG

The VIPS™ is unique, being the only single cell cloning system on the market that tracks a single cell’s arrival in the actual well with high resolution (z-stack) imaging and to support the subsequent daily whole well imaging provided by the Cell Metric.

Camile Evenou

Celonic AG

The VIPS system allowed us to shave off a few months from our development timeline and select highly stable single clones for manufacturing purposes.

Andy Tsun

Discovery Biology, Biotheus Inc.

The VIPS™ system and software has helped our company to deliver a high-quality data-package that meets global regulatory standards...The ease of use and reliability of the VIPS freed up valuable time.

Andy Tsun

Discovery Biology, Biotheus Inc.

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

Cell Metric X had the best whole-well imaging capabilities and clonality reports and, when we demoed the instrument, we were convinced by the robustness of the system and very high image quality.

Tom Kelly

Janssen

The Solentim ecosystem, [and Cell Metric X], allowed Wheeler to rapidly develop and launch a standardized cell line development service that is integrated with a scalable drug substance process.

Mike Brem

Wheeler Bio

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 Cell Therapies or are interested in learning more, please ask!

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Emma Morris

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Associate Product Manager - Reagents