News

Bionter is excited to announce that our exclusive particle counter, EVE, is now available on the Lumetics Link data import engine.

EVE our fully automated particle counter, goes beyond the limits of light obscuration, is non-destructive and fully compliant with all regulations.

An excellent achievement and collaboration for Bionter and Lumetics!

Bionter Announces Partnership Agreement with Midwest Biosolutions to drive market growth in the US

Basel, Switzerland – Bionter, an innovative analytical technology provider, is excited to announce its partnership agreement with Midwest BioSolutions, a prominent sales agency in the US market. The collaboration aims to drive market growth and expand the reach of Bionter’s products and services in the Biopharma industry in the US.

Through this partnership, Midwest Bio will utilize its extensive network and expertise to promote and sell Bionter’s products and services to Biopharma customers across the US. The agreement will enable Bionter to tap into Midwest Bio’s knowledge of the US Biopharma landscape and benefit from its sales and marketing strategies to enhance its market presence and drive growth.

“We are thrilled to partner with Midwest Bio to accelerate our growth in the US market,” said Angelika Schrems, Global Head of Business Development of Bionter. “Their extensive network and expertise in the Biopharma industry will enable us to expand our reach and better serve our global customers with sites in the US.”

The partnership agreement will focus on driving sales growth, developing marketing strategies, and expanding the reach of Bionter’s products and services in the US market. The collaboration will enable Bionter to access new market segments, enhance its customer base, and drive revenue growth.

“Partnering with Bionter is a fantastic opportunity for us to leverage our expertise in Biopharmaceutical manufacturing and complement our current portfolio to drug product testing and provide a broader solution portfolio to our existing clients,” said Jeff London, CEO of Midwest Bio. “We are so excited to enter into this partnership with Bionter and to introduce their superior technologies to North America.”

This partnership agreement is a testament to the commitment of both companies to drive innovation for Biopharmaceutical manufacturers. Stay tuned for more updates as Bionter and Midwest Bio work together to achieve their goals.

For media inquiries, please contact Angelika Schrems at bd@bionter.com.

About Bionter: Bionter is a Swiss-based Biotech start-up. Since the foundation in 2020, Bionter has established successful prototype testing with global Pharma companies, received successful seed funding from the US investor Dynamk Capital and launched their first product in Europe and the US. The team has significant experience in particle analytics as well as the commercialization of analytical testing products. Bionter’s first product, EVE, is a fully automated particle counter, that works non-destructive with the sample used and is fully compliant with current regulations.
Bionter is a premium supplier of analytical testing solutions and contributes to the benefit of people’s health by helping pharma companies and their service providers to bring drugs faster and safer to the market.

About Midwest Bio: Midwest Biosolutions is a US-based manufacturer’s representative group established in 2004. With a team of seasoned business development professionals, they have helped numerous industry-leading, global suppliers establish thriving direct-to-end user sales in the US pharmaceutical/biopharma market. Their knowledge of process applications combined with a vast network of industry contacts, allows them to provide a uniquely experienced perspective to both the suppliers they represent and the customers they support.

Non-destructive particle counting – ten23 health and Bionter collaborate to improve testing of particulates in sterile products.

Basel, 2nd of May 2023 ten23 health, a global contract development and manufacturing organization, and Bionter, a premium supplier of analytical testing technology, announced today their collaboration to advance innovative testing methods of particulate matter.

• Bionter has launched EVE, a fully automated particle testing system, to assess sub-visible particulate contamination for parenteral drug applications based on light obscuration.
• ten23 health has been running customer samples on an EVE system and is also acting as an application center for Bionter.
• Due to the non-destructive nature of Bionter’s EVE particle testing equipment, the same sample can be further analyzed with orthogonal analyzing methods whilst minimizing sample volume needed.
• The Bionter installation complements ten23 health’s comprehensive method and equipment panel for the characterization and assessment of aggregates and particulates, including light obscuration, automated flow imaging, nano-tracking analysis (NTA), Dynamic or Static light scattering stand-alone or coupled with chromatographic separation techniques, as well as identification of visible particles by spectroscopic methods.

Dr. Björn Boll, Senior Director for Particle Characterization and Drug Product Design at ten23 health commented: “We are excited to offer this new technology to our customers. It offers several advantages over established methods that could improve workflows due to automation and reduction of sample consumption.”

 

Dr. Tobias Werk, CEO of Bionter, stated: “We strive to develop innovative solutions for our customers. The partnership with ten23 gives us insight into the daily challenges of biologics analytics and allows and inspires us to further tailor our solutions to the true needs.”

About ten23 health

ten23 health®, located in Basel, Switzerland, is the human-centric and sustainable strategic partner of choice for the pharmaceutical industry and biotech start-ups: we develop, manufacture, and test modern medicines. We support our clients in developing differentiated, stable, usable, and safe injectable treatment options for patients. Our second site, located in Visp, Switzerland, is a world leader in the sterile production of complex pharmaceutical dosage forms and a wholly owned subsidiary of ten23 health. ten23 health combines the latest scientific findings with proven and tested worldclass industry and regulatory expertise to forge new paths for supporting clients. We provide our innovative services in a fair and sustainable manner, respecting people’s health and the future of our planet. ten23 health is solidly financed through the long-term commitment of 3i Group, an internationally reputable equity partner.

About Bionter

Bionter is a Swiss-based Biotech start-up. Since the foundation in 2020, Bionter has established successful prototype testing with 4 global Pharma companies, received successful seed funding from a US investor and launched their first product in Europe and the US. The team has significant experience in particle analytics as well as the commercialization of biotech products. Bionter’s first product, EVE, is a fully automated particulate matter detection system, that works non-destructive with the sample used and is fully compliant with current regulations. Bionter is a premium supplier of analytical testing solutions and contributes to the benefit of people’s health by helping pharma companies and their service providers to bring drugs faster and safer to the market.

Media contacts:

ten23 health: Mara Willa, mara.willa@ten23.health; +41 79 489 39 05

Bionter: Angelika Schrems, angelika.schrems@bionter.com; +41 77 266 53 96

3i Group: Kathryn van der Kroft, Kathryn.VanDerKroft@3i.com; +44 20 7975 3021

Tobias Werk, CEO of Bionter, is interviewed by Jim Cornall, moderator at Labiotech, about the latest news of Bionter.

https://podcast.labiotech.eu/

RIEHEN, Switzerland, April 27, 2022 – Bionter AG, experts in sub-visible particle testing, announced the completion of a $3 million Series Seed financing from Dynamk Capital. Bionter revolutionizes analytical testing of subvisible particles in the biopharmaceutical industry in respect to economy, process time and safety.

Proceeds from this round will help the company to expand their committed team, launch their first solution in 2022 ,and fuel their pipeline with new innovative developments.

“Bionter technology is a game changer in subvisible particle counting, one of the most important quality attributes of administered liquid biologics,” said Reinhard Vogt, chair of the Board of Bionter and Venture Partner at Dynamk Capital”

The financing accelerates the already exceptional momentum for Bionter’s initial offering. Bionter’s complete solution includes a particle counter supported with single-use consumables, maintenance and training, applicable for biotech’s drug product sector and based on a new combination light obscuration technology and smart automation.

A challenge faced by the biopharmaceutical industry is how to minimize the amount of costly sample required to determine particle count. Bionter’s device reduces the overall sample volume required, saving material for other analytical endpoints, hence reducing costs. Its smart automated workflow drives efficiency, minimizes human interaction and therefore improving reliability, data integrity and in turn patient safety. Bionter’s particle counter is also compliant to current USP/EP/JP regulations familiar with manufacturers.

The company has completed development of its patented technology and will launch it end of May 2022.

“This financing enables us to bring our first product to our customers while driving the development of new innovations,” said Dr. Tobias Werk, CEO of Bionter. “We are thrilled to have Dynamk Capital join our team, as they provide a wealth of experience growing life science tools companies and help position Bionter and help us to make our vision a reality.”

About Bionter AG
Bionter (www.bionter.com) is a recently founded Switzerland based company with the purpose of revolutionizing analytical testing for the benefit of people’s health. Bionter is driving patient safety, cost efficiency and sustainability through disruptive innovations in particle testing that are increasing the quality of drug product testing. Bionter`s first product is a particle counter that is not only fully automated but also allows non-destructive sample testing.

About Dynamk Capital
Dynamk Capital is a growth equity and venture capital firm focused on life sciences industrials. Dynamk’s investment strategy is centered on identifying companies developing disruptive technologies, tools, and services that enable the full biopharma continuum across discovery, development, and manufacturing of biotherapeutics, including cell & gene therapies and vaccines. Please visit www.dynamk.vc for more information.

RIEHEN, Switzerland, March 22, 2022 – A Swiss start-up is hoping to lower the costs of biologics development by adapting a quality control technology to the pharmaceutical industry. The new light obscuration instrument for sub-visible particle testing during product formulation is Bionter’s first product and will be launched between May and August.

“The light obscuration instrument is the first in a family of products, and the unique thing is that it doesn’t consume samples during testing,” explains Bionter’s CEO, Tobias Werk, PhD. “During formulation development, light obscuration alone consumes thousands and thousands of samples, and the material alone easily exceeds $1,000 for a single sample. So, by making it non-destructive, you open lots of opportunities to get insights faster and lower the cost of development.”

According to Werk, light obscuration technology is an established technique for sub-visible particle testing in the formulation phase of biologics development. However, because the technology was adapted from aerospace, he says it really wasn’t configured to the specific needs of the pharmaceutical industry.

“Light obscuration technology was developed around 1960 and was adopted into pharmaceutical [research] as a requirement because it could substitute for microscopy,” he explains. But, Werk says, since the technology has largely remained unchanged, except for the substitution of a laser for bulbs in the 1980s, this inspired him to set up Bionter in 2020 with the aim of creating tailored technologies for the pharma industry.

The new light obscuration instrument avoids destroying the sample by incorporating a drying step into the analytical process, he points out, which prevents contamination dilution as different samples are moved through the system.

Werk automated the instrument to allow operators to leave the equipment and changed the fluidics to deal with the viscosities for high-concentrated protein formulations and other biologics.

The new instrument, he notes, also didn’t require specific regulatory approval. “Our method uses off-the-shelf light obscuration technology, so it still conforms with regulations,” he says.

Werk is scheduled to speak about his technology this week at the Bioprocessing Summit Europe.