Diatheva srl

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

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

Adaltis S.r.l. is an international IVD company headquartered in Rome, Italy.

Adaltis develops, manufactures and markets in-vitro diagnostic systems and reagents to detect viral infections, diagnose immune system diseases and measure human hormone responses.

http://www.adaltis.net/products/

Personal LAB - fully automated 2 plate microELISA/IFA analyser
NEXgen - fully automated 7 plate microELISA / IFA analyser
EXTRAlab - Robotic systems for liquid handling, extraction/purification of nucleic acids
Pchem Family - clinical chemistry systems for 120-500 tests/hour
(Instruments and dedicated reagents).
HEMO One - Point of Care Analyser (Diabetes / Vitamin deficiencies / Metabolic disorders / Inflammatory diseases)

With more than 10 thousands of instruments installed worldwide, Adaltis is known for excellence in performance and innovation.

Adaltis’ development and production of reagents include a wide range of assays:
- Diagnostic kits for detection of infection agents by real-time PCR (MOLgen Line)
- MicroELISA kits (EIAgen)
- Clinical Chemistry / Turbidity / Latex (CHEMgen)
- Genomics & Bioinformatics

MDx kits and reagents for DNA/RNA complete extraction kits providing a wide range of clinical specimens (liquids, tissue, cells etc.), compatible with most DNA extraction kits on market.

Adaltis provides:
Dedicated Customized Services and Antibody Production.
Adaltis has a strong record in OEM / ODM development and production of systems and kits. Well known partners have experienced and enjoy the expertise and quality products of Adaltis.

Adaltis is ISO 9001 and ISO 13485 certified. Our products are IVD-CE marked.

All of our products are backed by dedicated application support and technical service.

Customer Care Center:
info@adaltis.net

Sales and Marketing Office:
sales@adaltis.net

Order Handling and Logistics:
order@adaltis.net

Tel: + 39 0774 5791

Explicyte is a family brand of specialty preclinical services launched by ImmuSmol, a bordeaux-based company. The first brand, Explicyte Immune-Oncology offers preclinical contract research services in immuno-oncology.

Explicyte Immuno-Oncology currently offers to test innovative cancer immunotherapies in vivo, using syngeneic mouse tumor models treated with immune checkpoint inhibitors (eg. anti-CTLA-4 and anti-PD1/PD-L1 antibodies). In addition, Explicyte is setting up an in vitro platform for the identification and optimization of novel immunomodulators. Equipped with high-content analysis technologies, the platform focuses on live phenotypic screening in co-cultures of immune and cancer cells, as well as molecular cell-based assays for the assessment of immune checkpoint inhibitors.

Within Basel neighbourhood and at the very heart of Europe (the triple border of France, Germany and Switzerland), Firalis is a pioneering biotechnology company, active in discovery, development and qualification of biomarkers (BM).

1) BIOMARKER PRODUCTS
Firalis develops BM-based diagnostic, prognostic and theranostic tools:
● RUO Kits (Research-Use-Only), based on validated innovative biomarkers
● IVD Tools (In Vitro Diagnostic), based on a combination of clinically qualified biomarkers

2) BIOMARKER R&D
● Development of proprietary BMs
- Cardiovascular, Inflammatory, Autoimmune and Neurology
● Drug Safety & Drug Efficacy
● Patient Stratification
● Personalized Medicine

3) BIOMARKER-RELATED CRO SERVICES
BM Discovery for laboratories, biotechs and pharmaceutical industry:
- Proteomics: Soluble biomarker measurements with several immunoassays technologies (ELISA, multiplex and high sensitivity platforms such as Luminex® BioPlex 200™, Meso Scale Discovery®, Singulex Erenna®, Protein Simple Ella™, Olink and Siemens Dimension® EXL™ 200)
- Genomics/Transcriptomics: Targeted sequencing of miRNA and mRNA (HTG EdgeSeq), lncRNA screening via Firalis proprietary platform, Next-Generation Sequencing (NGS) services (RNA-Seq, whole genome and exome sequencing, etc.) and qPCR/microfluidic qPCR (Gene Expression, SNP, CNV, etc.)
- Flow Cytometry: Immunophenotyping of preclinical and clinical samples, monitoring of pharmacodynamics on target cells in response to treatment and biomarker discovery
- Assay development and validation on various platforms, development of critical reagents (antibodies and proteins)
- Biobanking and sample repository services supported by LIMS
- Data analysis using multi-parametric statistics and development of predictive models
- Support of regulatory activities related to biomarker qualification with Health Authorities (FDA/EMA)
- Quality environment (ISO 9001, ISO 13485 (GMP), ISO 17025 (GLP/GCLP))

For more information please visit our website.