Clara Diagnostics is developing the Exosome Sorting System (ExoSS), a high-throughput microfluidic system for the isolation and purification of exosomes. The company aims to launch the first microfluidic exosome sorting device (ExoSS) into the marketplace for automated, high-specificity, and high throughput preparation of exact exosome subtypes from a variety of biofluids.
The ExoSS system performs isolation 100x faster than ultracentrifugation and able to extract greater than 90% of exosomes with an isolation purity greater than 90%. ExoSS rapidly runs parallel samples continuously, resulting in a platform ideal for large volume processing. Designed for low skill automation, ExoSS has the advantage of extracting all or only specific
types of exosomes from the biological source.
An On Site Non-Clinical Isolation Service (ExoSS OnSite) was launched in November 2018 by the company utilizing the existing ExoSS system.
Clara Diagnostics is focused on establishing strategic partnerships for development in diagnostic and therapeutic applications, equipment manufacturing, antibody sourcing, distribution, sales and marketing.
Hangzhou AllTest Biotech Co., Ltd is located in 550#，Yinhai Street, Baiyang District, Hangzhou Economic-Technological Development Area, the company registered capital of 15 million RMB. The company’s total construction area is about 3200 M2. The company holds strong ability of scientific research and innovative technology. AllTest Biotech leads the development frontier of biological technologies such as monoclonal antibody-colloidal gold and latex technique, gene engineering, compound antigen and immunoassay.
AllTest Biotech is thriving on design, development, manufacturing and sales of the lateral flow rapid IVD products and food safety test product. The product is broadly recognized in the international market for its rapid, convenience and accurateness. AllTest Biotech will strive to become the leader and pioneer in the diagnostic industry field of China and the world.
Kemwell is a contract biologics development and CMO company providing services to global biopharmaceutical organizations. Kemwell facilities, located in Bangalore, India, are designed and developed with technological support from a leading German pharma company. Kemwell provides customers with cost-effective access to state-of-the-art technology for all mammalian cell culture based products’ development and manufacturing.
15,000 sq. m. Kemwell facility consists of a cGMP drug substance manufacturing area with over 4500L bioreactor capacity, sterile fill and finish areas for cGMP drug product manufacturing and process development laboratories to support production of protein therapeutics from mammalian-cell culture – monoclonal antibodies, bi-specific antibodies, fusion proteins, etc. Kemwell is capable of supporting novel, bio-better and biosimilar programs’ preclinical development, clinical development, cGMP clinical manufacturing and cGMP commercial manufacturing.
Kemwell, having established in 1980, had long term associations with pharma majors such as Bayer, GlaxoSmithKline, Merck KGaA, Novartis, Pfizer and others for small molecule contract mfg. and R&D. In 2016, Kemwell divested its small-molecule division to focus on biologics, leveraging its vast and rich experience. Kemwell is now a 100% biologics CDMO.
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
- 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)
- Elemental Impurities
- Mass Spectrometry
- Molecular Biology
- Protein Characterisation
200 highly qualified professionals
more than 35 years’ expertise at the forefront of analytical sciences.
Our core competencies are:
- Development and validation of analytical methods
- Stability studies
- Batch (release) testing
- 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
Symphony was founded by eminent experts from Pharma Industry to create new bench mark in collaborative Research and Services.
Symphony provides Chemistry Services for:
Chemistry support for early stage drug discovery molecules, building blocks & scaffolds, analogues & library compounds synthesis
cGMP Kilo scale manufacturing & supply (up to 25Kg) of clinical drug substance (NCE) for preclinical to clinical studies
CMC documentation & support for NDA submission
Experience of working on more than 40 NCEs for our Global Innovator clients on FTE (Full Time Equivalent) & FFS (Fee For Service) client engagement models.
Custom Synthesis from mg to kg for non-catalogue/expensive catalogue compounds
Non-infringing and cost effective process development for generic APIs and intermediates and technical package submissions for commercial manufacturing
Process validations under cGMP pilot plant
Analytical (HPLC/GC) method development & validations
Symphony has expert team of Scientists and marketing professionals with an excellent track record of Research and timely delivery capabilities.