QUALITY ASSISTANCE S.A.

PathoQuest, spin out of Institut Pasteur, is a genomic expert company offering a game-changing next-generation sequencing (NGS) platform for microbiology testing.
The company has developed 2 applications:
• The QC of biological drugs (ATMP, Vaccines, antibodies…) allowing robust and fast analysis under GLP grade.
• The diagnosis of bloodstream Infections (including sepsis) directly from blood.
PathoQuest’s technology combines proprietary sample preparation protocols, applicable to several types of biological samples with proprietary pathogen genome sequence databases and automated analysis pipelines.

BIOLOGICS TESTING OFFER
PathoQuest offers Biotech and biopharmaceutical companies GLP grade solutions to secure the biosafety of biological drugs like cell & gene therapy products, vaccines and, recombinants by preventing adventitious agent contamination and cell-line misidentification.
Advanced NGS-based solutions supplement or replace traditional testing methods and support the strategic decision-making process allowing for a robust and unambiguous level of testing and faster turnaround time.
Based in Paris, France, PathoQuest has established a U.S. subsidiary and is expanding its capabilities by implementing a state-of-the-art testing facility at its location near Philadelphia. The company has also signed in 2018 a strategic partnership with Charles River Lab (Boston, USA)

DIAGNOSIS OF BLOODSTREAM INFECTIONS
- PathoQuest has developed iDTECT® Blood Test, the first and only clinical CE In Vitro Diagnostic (IVD) metagenomic test for infectious diseases.
- The test provides directly from blood to clinicians and microbiologists an improved method for detecting pathogens, particularly for immunocompromised patients with suspected infections. This new molecular diagnostic test is designed to improve antibiotic stewardship and lead to better patient care through personalized treatment.

For more information about PathoQuest, feel free to reach out!

HalioDx is an immuno-oncology diagnostic company providing oncologists and drug development organizations with first-in-class Immune-based diagnostic products and services to guide cancer care and contribute to precision medicine in the era of immuno-oncology and combination therapies.

Leveraging the pioneering work of Dr Jérôme Galon, HalioDx provides a unique range of immune scoring solutions including its flagship Immunoscore® assay for the assessment of the immune contexture of a tumor, as a key determinant of patients’ outcomes and response to cancer treatments.

HalioDx has developed a unique Biopharma partnering ecosystem for the identification of clinically relevant biomarker signatures, the demonstration of their clinical utility in trials and the development and commercialization of resulting diagnostic or companion diagnostic tests. Our programs draw on our expertise and focus on immuno-oncology, a complete suite of genomic and proteomic biomarker profiling services, a world-class data analysis and biostatistics platform, and CLIA-certified laboratories with compliant facilities in Europe and in the US to develop, manufacture, register and market in vitro diagnostic (IVD) products. HalioDx has rapidly become the preferred partner of Biopharma developing therapeutic antibodies, vaccines, chemotherapies, oncolytic peptides, and CAR-T cell therapies.

About Immunoscore®
Immunoscore® is an in vitro diagnostic test measuring the host immune response at the tumor site. It provides a robust, precise, quantitative, and consensus assessment of lymphocytic infiltration and has been shown to predict patient outcome and response to therapies in several indications.
Immunoscore® was included in the 2020 European Society of Medical Oncology (ESMO) Clinical Practice Guidelines for Diagnosis, Treatment and Follow-up for Localized Colon Cancer.
Immunoscore® is commercially available in more than 20 countries.

Selexis SA, a JSR Life Sciences Company, is the global leader in cell line development with best-in-class modular technology and highly specialized solutions that enable the life sciences industry to rapidly discover, develop and commercialize innovative biologic medicines and vaccines. Our global partners are utilizing Selexis technologies to advance more than 130 drug products in clinical development and the manufacture of eight commercial products. As part of a comprehensive drug development

As part of a comprehensive drug development process, the Company’s technologies shorten development timelines and reduce manufacturing risks. In June 2017, Selexis became part of the JSR Life Sciences group. JSR’s contract development and manufacturing organization (CDMO) service offering leverages the full capabilities of Selexis’ proprietary SUREtechnology Platform™ to offer an end-to-end solution to industry. More information is available at www.selexis.com.

The SUREtechnology Platform™ incorporates a number of proprietary technologies that are unique to Selexis:

ADVANCED GENE TRANSFECTION TECHNOLOGY AND PROCEDURES
- Selexis SGE® (Selexis Genetic Elements)
- SUREtech Vectors™

MEDIA AND FEED STRATEGIES

PROPRIETARY CHO-K1 CELL LINE
- Selexis SURE CHO-M Cell Line™ (CHO-K1)

GENOME AND TRANSCRIPTOME
- SURE CHO-Mplus Libraries™
- SUREscan®

Selexis is a science-driven organization, founded on the academic interests and discoveries of its core scientific team in molecular biology, cellular physiology, and genetic engineering, and is committed to the application of these insights and methods to continuous process improvement and practical problem-solving through close interaction with its industry clients and collaborators.

Global clients, representing the complete spectrum of life science enterprises—from research laboratories and biotech startups to Big Pharma—have utilized the unparalleled proprietary technology and highly specialized services of Selexis.

There are several GLP-compliant non-clinical CRO’s. Why choose the Aurigon Group?
• We're big enough to provide a full service, but small enough to fully adapt to your needs
• Our qualified staff consists of 70+ professionals, with even 30+ years of experience
• Our proven track record of more than 5700 studies gives us a solid base to serve your needs
• Our flexible approach and your direct contact to the Study Director gives you full control of your study

Aurigon offers a full range of in vivo and in vitro non-clinical services from development candidate to marketed product. These services include, but are not limited to: PK/PD, ADME, bioanalytics, toxicology and safety pharmacology in all species used in toxicity testing ranging from mouse to minipig.

For our clients we provide tailor-made services on a variety of test item classes including NCE, NBE, herbal extracts, vaccines, medical devices to name a few. We intend to build up long-term partnerships by acting as a problem-solver in our partners’ projects; keeping their budget, timeline and goals in mind.

Aurigon shares its expert knowledge and performs GxP training services (GLP, GMP for batch release assays, GcLP). Our clients will benefit from our comprehensive experience and get new insight into the GxP regulated environment.

As Central European Center for Minipig Research we possess a spacious site as well as sound professional experience for minipig testing. This is accompanied by facilities for small and large animal testing (rodents, rabbits, dogs, ...) as well as in vitro laboratories close to the city borders of Budapest. Furthermore, we maintain a well-equipped bioanalytical department in Budapest.

For more detailed information about our broad service portfolio you may also visit our website (www.aurigon.eu).

Get in touch and let us foster your project a wing stroke ahead!

Studies are performed by our sister company, ATRC Aurigon Toxicological Research Center Ltd.

EirGen Pharma, a subsidiary of OPKO Health Inc., was established in 2005 and employs over 200 people at two sites in Waterford, Ireland. Voted Irish Pharma company of the year (SME) in 2017 EirGen produces and supplies various pharmaceutical products globally, including those required for cancer treatment. OPKO is a publically traded healthcare company involved in the discovery, development, and commercialization of next-generation diagnostics, pharmaceuticals, and vaccines. EirGen Pharma R&D - an OPKO company, our Research & Development facility opened in June 2017.