Bioxtal

For over a quarter of a century, we have been supplying the world’s laboratories with the clinical diagnostic tools to effectively diagnose and monitor disease.

Binding Site was founded by a group of researchers from the Medical School at Birmingham University, UK. In the early 1970s, this group were researching innovative ways of producing antibodies. Today, we continue to build upon our specialist protein heritage offering an expanding menu of over 200 protein assays across a range of clinical diagnostic systems.

As demand grew for our expanding range of specialist protein assays, we introduced clinical diagnostic systems into our product offering in late 2007. Together, our specialist protein systems and assays provide laboratories with a complete specialist protein solution.

Our flagship assay, Freelite®, is the only serum free light chain assay recommended by national and international guidelines for the diagnosis, prognosis and monitoring of Multiple Myeloma and other B cell dyscrasias (cancers of the plasma cells). Our specialist protein systems are optimised for running Freelite® and other high sensitivity assays.

Understanding the impact of laboratory diagnostics on clinical patient management, we have never lost sight of the ultimate beneficiary of our products – the patient.

Binding Site – Committed to improving patient lives worldwide through education, collaboration and innovation.

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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.

Genalyte is a tech-enabled, full service CAP accredited and CLIA certified laboratory. We perform the majority of tests with our rapidly deployable mobile laboratory in under 30 minutes. Our central lab handles tests that cannot be performed onsite. All results are run through ClouldLab, our proprietary telehealth platform, for quality oversight and monitoring by Clinical Lab Scientists.
Core to our mobile capabilities is the Maverick platform, which has unprecedented serological testing functionality - permitting up to 64 simultaneous immunoassays on whole blood in 15 minutes. The platform achieved FDA clearance in Oct 2019. In these unprecedented times, we have developed a rapid COVID-19 serology test for IgG and IgM antibodies, while simultaneously including flu and other respiratory illnesses for differential diagnosis. Our COVID-19 serology panel will be available in early April.

For more information, visit www.genalyte.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

TGA BioServices, an Absorption Systems'​ Company, is an FDA inspected contract research laboratory providing the Pharmaceutical, Biotechnology and Research communities a comprehensive range of laboratory services in support of research and clinical studies. We offer the client a complete package of customized testing systems utilized in preclinical through Phase IV studies, all in compliance with cGLP and cGMP requirements.

We specialize in the development and validation of immunoassay systems for the detection of target molecules, antibody responses and quantification in total compliance with QA and cGMP standards.

TGA BioServices also offers in vivo mouse studies for the optimization of vaccine immunization schedules, dosing, adjuvant screening, immunogenicity testing for the release and stability of bulk and finished clinical product, as well as complete antibody development programs. Furthermore, we offer Guinea pig dermal sensitization testing for the identification of contact allergens. All programs are supervised by an in-house Institutional Animal Care and Use Committee (IACUC), while the facility is USDA registered and AAALAC accredited.

Other services provided include FACScan cell labeling studies, tissue culture, endotoxin testing, basic R&D activities, sample storage, specimen collection kits with on-site training, data management, protocol generation (SOP), database/statistical analysis and consultation. TGA BioServices has the credentials your project is searching for.