Draconis Pharma

Quality Assistance S.A. is a leading European Contract Research Organisation providing the pharmaceutical industry with all the analytical services required by EMA and FDA regulations for the development and marketing of innovative human medicinal products.

We assist our clients from candidate selection, through non-clinical and clinical studies, to marketing authorisation, using our state-of-the-art, product-dedicated expertise in analytical sciences.

For each customer and each project, we design customised solutions, define analytical protocols, develop and validate specific new analytical methods and perform characterisation, stability, pharmacokinetic, biomarker and immunogenicity studies as well as batch release testing, in order to evaluate the Quality, Safety and Efficacy of the given drugs.

Quality Assistance S.A. is an expert for the development of:
- Biologics (monoclonal antibodies, ADCs, proteins)
- New Chemical Entities, oligonucleotides, peptides
- Nanomedicine products
- Vaccines
- Cell-Based and Gene Therapy Medicinal Products

The company holds a unique position on the market with:
All its laboratories on one site (Donstiennes, Belgium)
- Bioanalysis (PK/TK/Immuno)
- Bioassays
- Biochemistry
- Chromatography
- Elemental Impurities
- Mass Spectrometry
- Microbiology
- Molecular Biology
- Protein Characterisation
200 highly qualified professionals
more than 35 years’ expertise at the forefront of analytical sciences.

Our core competencies are:
QUALITY (CMC)
- Development and validation of analytical methods
- Characterisation
- Stability studies
- Batch (release) testing
SAFETY/EFFICACY (Bioanalysis)
- Development and validation of bioanalytical methods
- PK/TK studies
- Immunogenicity studies
- Biomarker studies

The Quality Assistance environment is GMP, GLP and GCLP/GCP compliant.

Visit www.quality-assistance.com for more information

Ablynx, a Sanofi company, is engaged in the development of Nanobodies®, proprietary therapeutic proteins based on single-domain antibody fragments, which combine the advantages of conventional antibody drugs with some of the features of small-molecule drugs. Nanobodies have potential uses in the treatment of a range of serious and life-threatening human diseases. Ablynx advances a portfolio of Nanobody-based therapeutic programs in several major disease areas, including inflammation, haematology, immuno-oncology and oncology.

The acquisition of Ablynx (June 2018) continues Sanofi’s commitment to breakthrough innovation, focused on technologies addressing multiple disease targets with single multi-specific molecules. Sanofi is committed to accelerating Ablynx’s Nanobody development programmes.

Aptum is dedicated to assisting companies and academic researchers in the development of vaccines and research antibodies. Our unique software, based on own, patent-pending algorithms, allows to detect most immunogenic regions in the molecule, to define the ability of the peptide or protein fragment to elicit strong humoral or T-cell response. We also evaluate the sequence for its immunological complexity that allows to predict how specific to this particular molecule the immune response will be.

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.

Celentyx is a human immune system focused R&D and service company specialising in immuno-oncology, inflammation and autoimmunity in vitro assays using healthy donor and patient tissues and cells.

Celentyx’s unique ImmuKnowlogy™ platform allows rapid analysis of drug action on human immune cells - from healthy donors or patients with defined clinical disease. Drawing on the World-leading expertise of Celentyx personnel, which along with our strategic relationships with the MRC Centre for Immune Regulation and the Centre for Translational Inflammation Research (at the Queen Elizabeth 'Super-hospital', Birmingham), enables the human immune system to be investigated at the highest levels of resolution.

Celentyx's ImmuKnowlogy™ services enable partners to quantify efficacy, elucidate the mechanism of action of an immunomodulatory drug, facilitate lead candidate prioritisation or identify potentially negative impact of a drug on the human immune system prior to first administration to man.

Celentyx's Novel Clinical Indication Profiling™, which applies the powerful Immuno-Profiling™ platform to reprofile (repurpose) drug candidates for diseases of the human immune system (e.g. inflammation, autoimmune disease, allergy, graft rejection, lymphoma, leukaemia), has created an increasing portfolio of valuable drug indications.