Bioprocessing Industry

Bioprocessing Compliance & Conformity

Compliance is at the core of our instruments designed for the bioprocessing industry.

Meet Pharmacopeia Guidelines

Pharmaceutical companies are required to meet specifications for the excipients, drug substances, and final drug products.

These specifications should meet the quality standards in the:

  • United States Pharmacopeia/National Formulary (USP/NF)
  • European Pharmacopoeia (EP)
  • Japanese Pharmacopoeia (JP)
  • Chinese Pharmacopiea (CP)

Compendial pharmacopeial tests are standardized protocols for many pharmaceutical raw materials and finished products.

The OsmoTECH portfolio of osmometers meets osmolality testing guidelines stated in the above mentioned pharmacopeias. Ensuring the quality of products manufactured, released, and distributed globally in the biopharmaceutical industry.

Ensure Data Integrity and Data Management

Data integrity is the completeness, consistency, and accuracy of data. In the pharmaceutical and biotechnology industries, this can be achieved by ensuring the trustworthiness and reliability of electronic records.

The OsmoTECH portfolio of osmometers and the Artel portfolio of liquid handling calibration and verification instruments help you maintain compliance with built-in data integrity features that help support 21 CFR Part 11 and EU Annex 11 regulations.

Some features include:

  • Three-level user access
  • Password protection (LDAP)
  • Complete audit trail
  • Secure electronic signature

Regulatory Compliance & Conformance to ISO Standards are at the Heart of Data Integrity

In the world of liquid handling devices, whether your company needs to comply with legal requirements from regulatory agencies, or voluntarily aligns its processes to published consensus standards, your lab will benefit from increased productivity, higher quality results, and easier audits.

In both cases, there are two ISO standards and one ASTM standard important to note: ISO 23783 for automated liquid handlers, and ISO 8655, as well as ASTM E1154 for manually-operated liquid handling devices. The new ISO 23783 series was published in 2022, and major revisions to ISO 8655 and ASTM E1154 were published in 2022 and 2023, respectively.

Definitions, requirements and acceptable methods for measuring the volumetric performance, including dual-dye ratiometric photometry, are described in ISO 23783 Part 2 for automated liquid handlers, and in ISO 8655 Parts 7 & 8, as well as in ASTM E1154 for manually-operated liquid handling devices. Training requirements for pipette operators are described in ASTM E1154. Our Artel portfolio of liquid handling calibration and verification products, services, and trainings can help you conform to these standards.

GMP-Assurance

As safety and efficiency of a product are crucial in cell therapy, we are focused on providing the highest levels of hardware, software, consumables and service to ensure our solutions are GMP-ready.

The STUDIUS Powered Ecosystem delivers a consistent workflow when creating Master Cell Banks by incorporating critical data from VIPS® PRO single cell seeding and Cell Metric® X clone verification and colony outgrowth monitoring. The platform enables seamless data analysis across multiple instruments, eliminating a tedious and error-prone review of spreadsheets, while maintaining data integrity and traceability, and preparedness to be used in 21 CFR Part 11 compliant environments.

MatriClone contains the recombinant laminin-511 E8 protein fragment, the same component found in clinical grade laminin products, ensuring quality and consistency across your research and GMP iPSC workflows when combined with VIPS PRO’s GMP-certified single use consumables.  

Popular Educational Resources

Learn more by checking out our educational resources below

Bioprocessing Case Study

Successfully filing an IND using Solentim’s VIPS™ single cell cloning system

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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

Data Integrity and Compliance: What Every Lab Should Know

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Bioprocessing App Note

How Labs Achieve Data Integrity

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Bioprocessing App Note

How STUDIUS™ is Changing Cell Line Development

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Bioprocessing Webinar

New and Revised ISO Standards

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Bioprocessing Webinar

iPSCs & Single Cell Isolation – Considerations of Clinical Manufacturing Workflow

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Bioprocessing Webinar

Panel Discussion: ISO Standards, Calibrations, and Routine Tests for Liquid Handling Instruments

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Bioprocessing Posters

Animal Component Free Cell Culture Supplements to Accelerate Stable Cell Line Development

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Bioprocessing Posters

Exploring Osmolality as a CQA within RNA Therapeutics

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Bioprocessing Posters

Effect of Liquid Handling Quality Control on Biological Assay Performance

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Bioprocessing Knowledge Center

Data Integrity

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Bioprocessing Knowledge Center

Ratiometric Photometry Technology

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Bioprocessing Knowledge Center

Understanding Precision, Trueness and Accuracy

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Associated Products

Support, Maintenance, and IQOQ Services

Get the best performance from your Solentim 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 equipment.

Learn more

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 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

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

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 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 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 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

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

Equipment was easy to set up and easy to use. The [OsmoTECH HT] runs reliably and is great to have for running many samples.

Monica G

Biotech

[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

Before this instrument, all our clonal analysis was done manually. We used to spend hours on the microscope looking for wells containing colonies possibly derived from single cells. Now, everything is automated, we since we can track the cell growth over time, we can be absolutely sure that a particular clones is derived from a single cell.

Rodrigo Santos

Horizon Discovery

Very easy to use and produces good quality cell images, which are essential when monitoring outgrowth after limiting dilutions. The 10 plate cassette with automatic loading is very helpful for high throughput experiments, and the versatility of plate type makes the cell metric even more useful.

Ngarangi Mason

Horizon Discovery

The Cell Metric was designed with the end user in mind. Setup and use are easy and the ability to generate a clonality report at the end of a project is fantastic. I would highly recommend taking a very close look at the Cell Metric before adding any imaging system to a CLD workflow.

Ray Davis

RuffLife Consulting

The Solentim Cell metric has become a crucial instrument in our cell line development process. The instrument has allowed us to create reliable and consistent data which in turn results in us being able to track our cell lines and compare them to each other with ease. Images produced by this instrument are always of high quality, and it is easy to train new member of the team on this platform as the system is very user-friendly! ...The instrument is certainly worth the money we paid as it has allowed us to determine monoclonality and track colony growth ...

Emily Agro

Ultragenyx Pharmaceuticals

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

During expansion, we use InstiSHAKE CHO to support the adaptation of our clones to shaking culture. Thanks to InstiSHAKE CHO, we have significantly reduced the number of clones lost (by 90%) and have reduced the amount of time taken for cells to reach our desired viable cell density and viability by 7 days.  Taken together, the combined use of InstiGRO CHO and InstiSHAKE CHO can accelerate our CLD workflow up to 3 weeks with little compromise to productivity. 

CHO+PLUS

We use InstiGRO CHO to improve the efficiency of our cloning projects. The supplement has helped us achieve clonal outgrowth >80% and has reduced the time taken for clones to reach our desired confluence by 2 weeks! Taken together, the combined use of InstiGRO CHO and InstiSHAKE CHO can accelerate our CLD workflow up to 3 weeks with little compromise to productivity. 

CHO+PLUS

[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 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], 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

We’re here to help

If you have any questions about Bioprocessing Compliance & Conformity or are interested in learning more, please ask!

Contact Us

Sam Murray

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Director, RAQA & Service