Cellular Technology Limited — CTL

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

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.

View our Disclaimer – http://hub.am/1nostJZ

Bio-Xtal is historically a provider of structural biology services.
Since twelve years, our know-how in structural biology allowed us to perform projects ranging from domain definition to the structure resolution of protein/ligand or protein/protein interactions by Xray crystallography and NMR.
We put an emphasis on monitoring the activity of our targets to ensure the relevance of the structural data we deliver. Our policy is to systematically develop home designed activity assays during our structural biology projects.
Mastering eukaryotic and prokaryotic expression systems allows us to supply high quality protein for the needs of your compound screening as well as for structural studies of the selected compound’s complexes, guarantying the coherence of the results obtained on both sides
A new key service from of Bio-Xtal is the cytosoluble single chain antibody fragment selection (Cytobody™). These can be raised against any antigen within a very short delay (4 weeks) and are very well expressed in either mammalian or bacteria cells.
This allows their expression in Coli for large scale production and expression within mammalian cells for cellular biology applications.
The applications of the Cytobodies ranges from the discovery of new druggable sites in multi-domain proteins to immuno-detection, cell imaging, protein purification, and protein stabilisation.

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.