InDevR

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InDevR Collaborates with I&L Biosystems to Market Products in Western Europe

InDevR Collaborates with I&L Biosystems to Market Products in Western Europe

I&L Biosystems GmbH Opens the European Market for InDevR Sales and Customer Support

April 04, 2017 06:00 AM Eastern Daylight Time

BOULDER, Colo.–InDevR, Inc., an innovative life science company dedicated to improving biopharmaceutical and vaccine manufacturing, is pleased to announce an exclusive sales, marketing and customer support relationship with I&L Biosystems GmbH and its subsidiaries. The distribution agreement includes sales and support for the Cypher One™ and soon to launch VaxArray™ product lines throughout Western Europe.

InDevR manufactures and sells Cypher One™, an automated hemagglutination analyzer used by biopharmaceutical vaccine manufacturers and veterinary diagnostic labs. The Cypher One™ system automates and standardizes HA and HAI analysis and provides a digital, traceable record to enhance data quality and reliability. InDevR is also developing a comprehensive vaccine potency platform called VaxArray™. When fully launched, the VaxArray™ platform will measure both hemagglutinin and neuraminidase content of both seasonal and pandemic influenza. VaxArray™ will enable biopharmaceutical manufacturers the ability to generate consistent potency data throughout upstream and downstream testing and enhance process recovery applications. InDevR’s products support vaccine developers and manufactures by providing faster turnaround times and improved results at an affordable price. More information can be found at: https://indevr.com/products

I&L Biosystems, a European sales and marketing leader, was founded in 1991 and has been growing ever since. With a focus on sales and distribution of high-quality laboratory equipment to customers and researchers in the field of microbiology, cell biology, biotechnology and process control, I&L Biosystems have established themselves as a proven leader. I&L Biosystems is located in Germany and expands its coverage of western European countries through subsidiaries located in the Netherlands, France and UK. I&L Biosystems’ mission complements InDevR’s unique product lines as both are focused on modernizing the field of life science with respect to vaccine development and production.

“I&L Biosystems brings unparalleled knowledge and expertise to our current and future customers. They offer in-country support with a team of native language speakers that really understand the challenges, successes and trends our European customers experience on a day to day basis,” said Dawn Bitz, Chief Commercial Officer of InDevR. “We are excited to reestablish this relationship with a trusted partner.”

“Our long-lasting relationship with InDevR is based on trust, scientific exchange and a fundamental connection. The combination of InDevR’s knowledge and I&L Biosystems’ experience in the European market is grounded in past successes. Now we are proud to introduce InDevR’s newest technologies into Europe with the confidence that InDevR instruments will be an incredible benefit to our customers,” said Dr. Sandra Balkow, Scientific Sales Director of I&L Biosystems GmbH.

About InDevR

InDevR has a demonstrated commitment to innovative solutions for the life science industry. With a focus on enhancing vaccines and other biotherapeutics, InDevR has emerged as a leader in progressive analytical technologies which has enable accelerated development and manufacturing of their life-saving products. For more information about the company and products, please visit www.indevr.com or call 303-402-9100.

About I&L Biosystems

I&L Biosystems GmbH and its subsidiaries offer high-tech Life Science products throughout all of Europe. They not only build long lasting partnerships with established suppliers around the world but also continuously integrate new technologies into their portfolio. They offer both evidence based scientific consulting as well as professional technical services, which allows them to provide their customers with the best possible support from initial contact throughout installation and beyond. For further information please visit http://www.il-group.eu

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Cypher One New Software Released

InDevR Launches Next-Generation Software for the Cypher One™ System

Next Generation Cypher One™ Software Increases Functionality and Ensures Data Integrity for the Standardization of Hemagglutination and Hemagglutination Inhibition Assays

BOULDER, Colo.–(BUSINESS WIRE)–InDevR, Inc., an innovative life science company dedicated to improving biopharmaceutical and vaccine manufacturing, today announced the global launch of the next-generation Cypher One™ 3.1 software to further enhance the functionality of the Cypher One™ automated hemagglutination (HA) and hemagglutination inhibition (HAI) interpretation instrument.

The new 3.1 software version provides users with many enhanced features that build upon the usefulness of the existing platform. Next generation software includes an improved interface with a new startup screen and other features making the system more user friendly. Increased plate flexibility has also been integrated giving the user the ability to toggle between horizontal and vertical sample use orientations as well as additional exported analytical data to enable tracking and trending of quality control metrics. Finally, with data integrity needs on the rise, the entire system enables compliance with 21CFR Part 11 and Annex 11 guidance.

Overall the Cypher One™ system simplifies analysis of HA and HAI assays, provides enhanced data integrity and reduces risk by providing interpretation consistency and standardization to minimize human errors. The Cypher One™ is used by leaders in the field of human and veterinary flu vaccine manufacturing, contract research organizations, academic institutions, veterinary diagnostic labs, and government entities.

The launch of the next generation 3.1 software expands the benefits of the Cypher One™ instrument and provides an opportunity to continue standardization and data record creation of hemagglutination analysis in serology and virology testing,” says Dawn Bitz, Chief Commercial Officer at InDevR. “With this launch, we continue our dedication to improving influenza vaccine manufacturing by developing innovative, analytical tools that provide superior results.”

Hemagglutination assays are widely used in serology and virology, with applications ranging from blood typing to vaccine efficacy. Currently, hemagglutination assays rely on subjective, manual interpretation, which can lead to significant variations in the measurement between technicians and laboratories. There are a number of industrial and government groups calling for improved standardization in vaccine characterization, e.g., Global Health Network’s CONSISE (https://consise.tghn.org/). In response to these initiatives, InDevR developed an optical analyzer with proprietary software to automate and standardize results interpretation.

Development of the Cypher One system was funded in part by a National Institutes of Health 2-year Phase 1 Small Business Innovation Research grant sponsored by the National Institute of Allergy and Infectious Diseases (R43 AI106054).

For more information about the Cypher One system, click here.

About InDevR

InDevR has a demonstrated commitment to innovative solutions for the life science industry. With focus on enhancing vaccines and other biotherapeutics, InDevR has emerged as a leader in progressive new analytical technologies that enable accelerated development and manufacturing of these life-saving products. For more information about the company and products, please visit www.indevr.com or call 303-402-9100.

HHS is not responsible for the contents of this release. The statements contained in this release do not constitute endorsement or recommendation by the U.S. Government or HHS.

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VaxArray Study Published in Vaccine

VaxArray Flu Vaccine Potency Study Published in Vaccine

InDevR’s Study, “VaxArray Assessment of Influenza Split Vaccine Potency and Stability” published in Vaccine

BOULDER, Colo.–(BUSINESS WIRE)–InDevR, Inc., an innovative life science company dedicated to improving biopharmaceutical and vaccine manufacturing, announced study results and publication of “VaxArray Assessment of Influenza Split Vaccine Potency and Stability” in the pre-eminent journal Vaccine.

In the study, the VaxArray Seasonal HA potency assay exhibited good overall accuracy, precision, and stability indication properties when compared to single radial immunodiffusion assay (SRID/SRD) for both monobulk intermediates and multivalent split-virus flu vaccines from the 2015-2016 flu season. Relative to SRD, VaxArray exhibited a number of advantages, including speed (time to result 2 hrs vs. 48 hrs), off-the-shelf availability, greater sensitivity, wider linear dynamic range, and application to in-process samples. This work establishes VaxArray as a promising alternative to SRD in vaccine potency determination.

The VaxArray assay is the first commercially available kit for rapid quantification of flu vaccine potency. The current gold standard method (SRD) is tedious and time-consuming, requiring hours of skilled hands on time for analysis. To conduct SRD, each laboratory must obtain all of the materials to create immunodiffusion gels, thus analysis can be inconsistent between laboratories. In contrast, VaxArray reagent kits are produced under ISO 13485:2003 quality management systems and are available for immediate use. Because VaxArray is off-the-shelf, the assay can be used at all stages of flu vaccine development, from the “seed lab” where virus growth is optimized, throughout all purification, concentration, and formulation steps.

“This study represents the first published results for VaxArray applied to a commercially available split-virus flu vaccine. An exciting message of the VaxArray story is that it can help manufacturers improve their development and characterization of vaccines, even in the upstream processes that involve challenging conditions,” said Kathy Rowlen, Chief Executive Officer of InDevR.

Development of the VaxArray Influenza product was supported in part by SBIR Phase I and II grants from the National Institute of Allergy and Infectious Diseases (NIAID). In addition to VaxArray for seasonal flu vaccines, InDevR is developing advanced versions of the assay for use with potential pandemic strains of influenza, for high throughput applications and even neuraminidase quantification. The VaxArray platform can also be adapted for other vaccines. According to Rowlen, “With appropriate changes to the reagents, the VaxArray platform could be used to determine potency for any vaccine. For example, in response to recent outbreaks, we are now exploring application of VaxArray to Ebola, Zika and other vaccines.”

VaxArray Influenza potency assay is available as a testing service or a product kit. More information is available at: VaxArray™ Influenza.

About the Study:

“VaxArray Assessment of Influenza Split Vaccine Potency and Stability,” by Laura R. Kuck, Ph.D.; Stephen Saye; Sam Loob; Sylke Roth-Eichhorn, Ph.D.; Rose Byrne-Nash, Ph.D.; Kathy L. Rowlen, Ph.D.: http://www.sciencedirect.com/science/article/pii/S0264410X17302220 published by Elsevier JVAC-D-16-01994R1 (now JVAC 18403) doi: 10.1016/j.vaccine.2017.02.028

About InDevR:

InDevR has a demonstrated commitment to innovative solutions for the life science industry. With focus on enhancing bioprocessing for vaccines and other biotherapeutics, InDevR has emerged as a leader in progressive new analytical technologies that enable accelerated development and manufacturing of these life-saving products. For more information about the company and products, please visit www.indevr.com or call 303-402-9100.

About Vaccine:

Vaccine is the pre-eminent journal for those interested in vaccines and vaccination. It is the official journal of The Edward Jenner Society and The Japanese Society for Vaccinology and is published by Elsevier www.elsevier.com/locate/vaccine

Copies of this paper are available to credentialed journalists upon request; please contact Elsevier’s Newsroom at newsroom@elsevier.com or +31 20 485 2492

HHS is not responsible for the contents of this release. The statements contained in this release do not constitute endorsement or recommendation by the U.S. Government or HHS.

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Dawn Bitz Joins InDevR

InDevR Appoints Dawn Bitz as Chief Commercial Officer

Addition Strengthens Executive Team and Provides Demonstrated Leadership in Executing Commercial Strategies for Life Sciences Products

BOULDER, CO (June 28, 2016) — InDevR, a Boulder-based progressive analytical technology, life science instrumentation and medical device company, announced the appointment of Dawn Bitz as Vice President, Chief Commercial Officer, effective immediately. Prior to joining InDevR, Mrs. Bitz, was a successful entrepreneur and executive holding $500M+ global P&L responsibilities.

“Dawn is a tremendous leader who will build a world-class commercial team at InDevR,” said Dr. Kathy Rowlen, Chief Executive Officer. “Her experience in growing world-class businesses, planning and executing commercial strategies and overseeing multiple launches will play a critical role in InDevR’s next phase of growth”.

During her outstanding 20+ year career, Mrs. Bitz has been a successful corporate executive, entrepreneur and consultant. She has held prominent positions with multi-billion dollar medical device and pharmaceutical companies, consulted for small and mid-cap companies, led mergers and integrations of $250M acquisitions, and has held $500M+ P&L responsibilities globally. Early in Ms. Bitz’ career she worked clinically on the ambulance and in the hospital and managing both pharmaceutical and medical device research studies. She translated that foundation into a successful business management and commercial career. Ms. Bitz has led global marketing, sales, product development, business development and commercial operations for companies like Covidien, Boston Scientific and UCB Pharma. She also founded and sold a consumer product goods and technology company. Ms. Bitz will lead InDevR’s commercial efforts, including product sales, marketing, business development and licensing, communications, public relations and investor relations.

Ms. Bitz holds undergraduate degrees in biology and chemistry from Texas Christian University and is a registered nurse and paramedic.

“I am excited to join InDevR at a time when we have the opportunity to shape commercial strategies for new and innovative ways to streamline and expedite the commercial vaccine production process. I look forward to building and leading a top-tier organization that will impact our ability to fight influenza and other public health issues,” said Mrs. Bitz.

About InDevR
InDevR has a demonstrated commitment to innovative solutions for the life science industry. With focus on enhancing vaccines and other biotherapeutics, InDevR has emerged as a leader in progressive new analytical technologies that enable accelerated development and manufacturing of these life-saving products. For more information about the company and products, please visit www.indevr.com or call 303-402-9100.

Certifications

ISO 13485:2016 Certification

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