BioAscent

Clean Cells is a GMP-licensed Contract Development and Manufacturing Organization providing R&D, production and quality control testing services to the biopharmaceutical industry.
Our two-part site located in Western France holds an innovative process development platform, BSL2 and BSL3 GMP manufacturing laboratories and analytical areas to develop bespoke assays and perform GMP testing.
Clean Cells is part of the Clean Biologics group and benefits from the additional experience of sister company Naobios, a CDMO with considerable experience in the development and manufacture of virus-based products.

EDASA Scientific Limited is a Chemistry Contract Research Organization active in Organic Synthetic Chemistry.

Exclusive access to the best Russian brains and facilities.
Cutting-edge thinking.
Progressive research.
A highly experienced and flexible approach.
EDASA delivers innovative compounds and creative solutions with considerable economies of cost and time.

EDASA Scientific provides solutions for:

Medicinal Chemistry Projects
Custom Synthesis
Natural Product Synthesis
Synthetic Pathway Design & Optimization
Compound Isolation/Purification Services
Synthetic Scale up Work & API production
Radio-Labeling
Chemical Waste Management

EDASA Scientific’s R&D site is based in Moscow State University’s (MSU) Science Park. As a result, EDASA Scientific has access to MSU’s facilities, as well as a broad range of scientific instruments for compound characterizations such as X-ray, bidimensional NMR, elementary analyzers, and HPLC. EDASA Scientific has access to talented MSU students and premium Russian scientists to be allocated for our collaborator‘s projects. We are also able to partner with MSU’s biological organizations for project follow-ups in biology.

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.

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

ABS Laboratories is a MHRA, GLP and GCP accredited contract research organisation. We specialise in the quantification of drugs, metabolites and biomarkers in biological fluids using LC-MS/MS, GC-MS, LC-UV and multiplexed biomarker assays.

Our bioanalytical staff are experts in developing, validating and applying sophisticated analytical techniques to achieve the desired out comes all within the regulatory frame work.

ABS prides its self on the quality of its customer service and rapid turn around times. Our skills and state of the art equipment enable us to support a wide range of studies small and large.

We have a wealth of experience supporting Pharmaceutical R&D, Universities and Charitable Organisations from in-vitro research through to preclinical and clinical studies to final MAA/NDA submission. We are also proud to work with the NHS supporting clinical diagnosis, screening and therapeutic drug monitoring.

ABS also owns a large library of validated bioanalytical methods for multiple drugs so is pleased to offer very rapid initialisation and analysis of study samples.