Aptec Diagnostics nv

F-star is a leading clinical-stage biopharmaceutical company delivering tetravalent bispecific antibodies for a paradigm-shift in cancer therapy. By developing medicines that seek to block tumor immune evasion, the Company’s goal is to offer patients with cancer greater and more durable benefits than current immuno-oncology treatments. Through its proprietary tetravalent, bispecific antibody (mAb²™) format, F-star is generating best-in-class drug candidates with broad therapeutic index and monoclonal antibody-like manufacturability. Building on the combined expertise of its world-class management team and scientific leadership, F-star is poised to deliver the next breakthrough immunotherapies for patients with cancer.

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

Abliance masters essential technologies to develop new generation antibodies. Our team of experts closely works with research laboratories, diagnostic industry, actors of clinical research and biopharmaceutical industry to understand the needs associated with each application, its regulatory environment and economic constraints. Abliance provides antibodies that perform in their application by designing unique solutions.

Founded in 2006, Abyntek Biopharma S.L. is a private Spanish company aimed at providing an integral and personalized service in the supply of antibodies.
Our company has two main business lines. On one hand, we are distributors of over twenty companies offering a comprehensive catalogue of more than 2 million antibodies, ELISA kits and proteins in general. On the other hand, we are the Spanish leading provider of custom monoclonal and polyclonal antibodies for R&D use. To this end, Abyntek can synthesize the necessary antigens (proteins and peptides) or make use of the client´s. We also offer antibody modifications such as biotinylation or conjugation to fluorophores and enzymes.
Come to visit our webpage (www.abyntek.com) and learn more about us. If you have any antibodies need, our international scientific team will be glad to help you!
Contact us and enjoy the experience of a special treat.

Abyntek on Twitter: bit.ly/1rummfr

Accelerō® Bioanalytics GmbH is a certified GLP test facility, and operates in compliance with ICH GCP regulations. Competent authorities approved Accelero´s Biosafety Level S2 laboratories for both microbiology and genetic engineering.

Accelero is proud to serve our clients with:

• OECD GLP approved facilities for analytical, non-clinical studies.
• ICH E6 R1 GCP compliant analytical facility for clinical phase 0 to 3 studies.
• Facility approved for handling and cultivation of BSL-2 micro-organisms (bacteria, yeasts).
• Facility approved for genetic engineering / cloning / analysis of safety level S2 GMOs
(bacteria, yeasts, viruses, plants, animals).
• Approval for the import and analysis of animal by-products from non-EU countries (e.g. like U.S.A., China).

Accelero services include, but are not limited to:

• Pharmacokinetic / toxicokinetic characterization (ELISA, qPCR, immuno qPCR).
• Biodistribution and shedding (qPCR).
• Biomarker screening on the RNA level (qPCR, microarray) and the protein level (microarray).
• Cell-based in vitro immunoassays (ELISA, EliSpot, flow cytometry).
• Particle-based multiplex immunoassays (flow cytometry).
• Particle-based multiplex miRNA (microRNA) assays (flow cytometry).
• Cell proliferation and cytotoxicity assays (flow cytometry, EliSpot).
• Gene expression assays (RTqPCR).
• GLP training services (basic courses, in-house trainings).
• Antibody detection assays (ADA): screening, confirmatory, neutralization (EliSPOT).
• Preclinical consulting services with regards to GLP and bioanalysis.
• Complement activation monitoring.
• Supply chain services e.g. like sample transport and shipping organisation, preparation of clinical kits.

All analytical methods are developed and validated according to the respective EMA, FDA, and/or ICH guidelines.

Accelero® is a trademark fully owned by Accelero Bioanalytics GmbH, Berlin (Germany).

Last update of this page: 31-DEC-2017 by CL