Vienna, Austria, 10th April 2024: ViruSure GmbH (www.virusure.com), a leading contract research organization (CRO) providing pathogen safety testing services for the global biopharmaceutical industry, has announced a collaboration agreement with neotem Bioanalytics. With over 25 years of experience, neotem is renowned for its expertise in combining fast and precise transmission electron microscopy (TEM) analysis with the high-quality standards of Good Manufacturing Practice (GMP).

ViruSure specializes in a comprehensive range of services encompassing virus and prion safety testing for biopharmaceutical products. These services include cell banking and characterization, in vivo biosafety studies, molecular and potency testing, GMP storage, sequencing, and Next-Generation Sequencing (NGS). These services are vital for biopharma and biotech companies focusing on biological products such as recombinant proteins, vaccines, human and animal-derived biological products, Advanced Therapy Medicinal Products (ATMPs), and cultured meat.

Dr. Andy Bailey, CEO, and co-founder of ViruSure, expressed his enthusiasm about the collaboration, stating, “We are delighted to announce this collaboration with neotem Bioanalytics, which resolves a bottleneck for high-quality and rapid transmission electron microscopy (TEM) analysis. We anticipate that this collaboration will assist our clients in improving timelines for pathogen safety testing.”

Angelika Spreitzhofer, Director of Quality Assurance at ViruSure, highlighted the commitment to excellence, stating, “I am proud that we could support neotem Bioanalytics in their efforts to enhance the quality system to achieve state-of-the-art GMP-compliant services for cell banks, virus banks, bulk harvests, and AAV testing via transmission electron microscopy (TEM) analysis.”

Dr. Dietrich Bäumer, Project Director at neotem, remarked, “After the move into our new facility, the collaboration with ViruSure marks the next step in our company development, benefiting from access to ViruSure’s wide global client base.”

Ashley Stephen Layland, Project Director & Head of GMP Project Management at neotem, commented on the seamless collaboration between ViruSure and neotem, saying, “It was a great pleasure to work closely together with the ViruSure team to establish rapid procedures for sample preparation and shipment to ensure TEM testing of bulk harvests, cell and virus banks, as well as gene therapy vectors within unbeatable timelines.”

About ViruSure GmbH

ViruSure is an established CRO offering a wide range of services in virus and prion safety testing, cell banking, cell bank characterization, in vivo biosafety studies, molecular and potency testing required by pharma and biotech companies. The company is committed to providing the highest level of quality, customer service, and regulatory compliance for pathogen safety testing. ViruSure’s state-of-the-art facilities in Vienna, Austria, are certified to both GMP and GLP standards, supported by a risk-based quality management system to ensure cutting-edge service to the biopharmaceutical industry. Further information on ViruSure can be found at www.virusure.com.

neotem Bioanalytics-IIT GmbH

neotem Bioanalytics focuses on GMP-compliant electron microscopy services for the biotech and pharmaceutical industry. As part of the “Institut für Innovationstransfer an der Universität Bielefeld GmbH” (IIT-GmbH), neotem has a combined experience of over 40 years in electron microscopy, complemented by expertise in cell culture technology, virology, and quality assurance. Further information on neotem can be found at www.neotembio.com.

Vienna-Bielefeld/17th of April 2024

SOURCE

ViruSure GmbH

MEDIA CONTACT

ViruSure

Dr. Ralf Klein

Director Business Development

+49 174 319 1173

Ralf_Klein@virusure.com

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In light of the current revision of the ICH5QA guideline, the discussion revolved around virus safety testing and new approaches on virus clearance studies, next generation sequencing (NGS) as a new tool in pathogen safety testing, testing strategies for ATMPS, mergence of SARS-CoV-2 in plasma production and virus reduction for plasma derived proteins, analytical methods for gene therapy products as well as continuous manufacturing and its impact in testing strategies.

We would like to thank all renowned external speakers as well as our in-house experts for sharing their knowledge on such relevant topics and facilitating inspiring discussions during the workshop.

The presentation deck from the event is available for downloading. Please find them here.

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We are excited to announces that the certification process by Oxford Nanopore Technologies has been completed successfully! Find us listed under the global service provider.

Contact us to learn more about how our next generation sequencing (NGS) services can support your needs

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Asahi Kasei Medical has completed its acquisition of Bionova Scientific, LLC, a provider of contract process development services and GMP-compliant contract manufacturing services to biopharmaceutical companies as announced on April 19, 2022. The acquisition represents a strategic complementary addition to Asahi Kasei Medical’s bioprocess business, which is renowned for Planova virus removal filters, MOTIV inline buffer formulation systems, ViruSure viral safety testing services and Bionique mycoplasma safety testing services.

We are very pleased to see Asahi Kasei Bioprocess division expanding into the CDMO business and to strengthen our presence in the US market.

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ViruSure’s dedicated team of experts is working full speed to make it possible to offer our customers NGS-based solutions soon.

The PromethION will further be used for conducting a spiking study together with other industry leaders and regulatory experts of the Advanced Virus Detection Technologies Interest Group (AVDTIG). The aim of this study is to demonstrate virus detection capabilities of long-read NGS technologies. ViruSure joined the AVDTIG a year ago to gain insights into current regulatory opinions and to contribute to the rapidly developing field of NGS with our own pertinent experience and expertise.

Stay tuned for further updates regarding our NGS progresses.

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The acquisition brings together the unique mycoplasma and viral safety proficiencies of ViruSure and Bionique, enabling Asahi Kasei Medical to offer clients expansive and exceptionally reliable biosafety testing support that is based on industry-leading scientific expertise, and is delivered via customized, trustworthy project partnerships. Asahi Kasei Medical is also actively investing in the Bionique facilities in Saranac Lake, NY, USA and employment expansion at the operating sites of both Bionique and ViruSure, to meet increasing demand for its testing services.

“We are excited to have a strategic partner like Bionique as part of the Asahi Kasei Group, and the expertise in mycoplasma testing that they bring will further strengthen our goal to better service our customers in all areas of biosafety testing” said Andy Bailey, CEO of ViruSure.

About ViruSure GmbH

ViruSure is an established CRO offering a wide range of services in the areas of virus and prion safety testing for biopharmaceutical products, cell banking and cell bank characterization services and in vivo biosafety studies (adventitious agent testing, tumorigenicity testing, oncogenicity testing) and molecular and potency testing, all required by pharma and biotech companies specializing on biological products (e.g. recombinant proteins, vaccines, human and animal derived biological products, cell based therapies). The company brings a wealth and breadth of expertise to ensure that biopharmaceutical companies meet all relevant pathogen safety testing requirements. Our goal is simple – to offer the highest level of quality, customer service and regulatory compliance for pathogen safety testing. Our state-of-the-art facilities located in Vienna, Austria are validated and certified to both GMP and GLP standards and all testing services are supported by a state-of-the-art risk-based quality management system which ensures we remain cutting edge partner dedicated to providing, first and foremost, a quality service to the biopharmaceutical industry. Further information on ViruSure can be found at www.virusure.com.

About Bionique Testing Laboratories LLC

Bionique offers the full breadth of mycoplasma testing services from lot to final drug product release testing per regulatory guidelines, as well as a GMP-compliant Real-Time PCR assay to support clients’ needs from discovery to clinical trials. Bionique specializes in mycoplasma testing of cell therapies, cell banks, raw materials, unprocessed bulk harvest, and final drug products. Additionally, our highly experienced team has expertise in method development and validation to support the emerging applications of Rapid Microbial Methods (RMM) and commercialization for biopharmaceutical and cell therapy products. Additional services such as regulatory and compliance consultancy add to Bionique’s unique position in this niche analytical testing space. Located in Saranac Lake, NY, Bionique’s facilities include two GMP-compliant contract testing and contract R&D laboratories. Bionique aims at offering mycoplasma testing services of unsurpassed quality, to meet the custom scientific and regulatory needs of each client and partner. Further information on Bionique can be found at www.bionique.com.

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