BIOTEM Custom Antibodies & Services

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.

Soft Flow was founded in the USA in 1988 and moved to Hungary in 1992. Soft Flow is a leading biotechnology company in the fields of flow cytometry, molecular biology and developing analytical solutions for food/feed safety, with almost 30 years of experience in R&D and cooperation with the market leaders in biotechnology and in food analytics. Soft Flow has grown into an internationally recognized R&D Excellence Center which employs over 60 highly qualified people. The company operates in Pécs, Hungary.
In 2016, Soft Flow was acquired by FOSS Analytical, a Danish company known throughout the world for innovative analytical solutions that help to improve food quality and safety in the global food market.
FOSS employs more than 1600 people working all over the world. The analytical instruments are marketed and sold through a global network of sales subsidiaries in 28 countries and by more than 75 dedicated distributors spread over Europe, North, South and Central America, Africa, Asia, and Australia. FOSS research and development is located in two sites, Hillerød and Pécs.

Activities:
Biotechnology Research and Development
- Monoclonal antibody development
- Polyclonal antibody development
- Recombinant protein development
- Phage display
- Conjugational and Organic chemistry
- Immunoassay development (flow cytometry, ELISA, FLISA, lateral flow)

Bioanalytical Services
- Mycotoxin reference analysis
- Antibiotic reference analysis
- Reference chemical analysis from grain, wine, oil, milk
- HCS microscopy

Reagent Production
- Monoclonal antibodies
- Recombinant proteins
- ELISA kits
- Reagents for multiplex microbead matrix technology

Software and Hardware Development, Engineering
- Designing automated measurement systems, instruments
- Planning and testing the Hardware components
- Creating user interfaces to show results (Angular, HTML, CSS)
- Implementing backend services to analyze and store data (.NET Core, C#)
- Controlling HW components using embedded C++

Evotec is a life science company with a unique business model that delivers on its mission to discover and develop highly effective therapeutics and make them available to the patients. The Company’s multimodality platform comprises a unique combination of innovative technologies, data and science for the discovery, development, and production of first-in-class and best-in-class pharmaceutical products. Evotec leverages this “Data-driven R&D Autobahn to Cures” for proprietary projects and within a network of partners including all Top 20 Pharma and over 800 biotechnology companies, academic institutions, as well as other healthcare stakeholders. Evotec has strategic activities in a broad range of currently underserved therapeutic areas, including e.g. neurology, oncology, as well as metabolic and infectious diseases. Within these areas of expertise, Evotec aims to create the world-leading co-owned pipeline for innovative therapeutics and has to-date established a portfolio of more than 200 proprietary and co-owned R&D projects from early discovery to clinical development. Evotec operates globally with more than 3,700 highly qualified people. The Company’s 14 sites offer highly synergistic technologies and services and operate as complementary clusters of excellence.

Oroxcell is an independent research organization (CRO) offering research services assessing the safety, toxicity and efficacy of active ingredients and finished formulations.

Specialized in in-vitro testing, particularly in 3D Human Models, Oroxcell is developing its business on two fronts:

• Safety & efficacy testing: From screening to GLP Compliant studies, we provide well established In-vitro platform, 2D and 3D models, for performing routine and regulatory safety testing, ADME (Absorption, Distribution, Metabolism, and Elimination) and Toxicity (sensitization, phototoxicity and genotoxicity) tests, bioanalytical studies, for evaluating pharmaceuticals, medical devices, cosmetics, nutraceuticals, home care and chemical products.

• Research & Innovation: Oroxcell provides a wide range of services including R&D project management and technical support, international consortium setup and management and regulatory & toxicology consulting.
We assist you in selecting or developing the best alternative testing methods for your safety and efficacy issues.

Oroxcell has been certified GLP compliant (Grade A, the highest grade) since 2011 by the French National Medicines and Cosmetics Safety Agency, ANSM.


Website: http://www.oroxcell.com
Contact: contact@oroxcell.com

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