Biological E. Limited

This channel is intended only for US and Canadian visitors. The life science business of Merck KGaA, Darmstadt, Germany operates as MilliporeSigma in the US and Canada. An unaffiliated and unrelated company, Merck & Co. holds the rights in the trademark MERCK in the US and Canada.

Bringing pharma and biopharma healthcare solutions to life is complex, requiring specialist knowledge and expertise at every step.

This is why MilliporeSigma offers the BioReliance® portfolio – an offering of exceptional, risk-mitigating approaches, testing, critical services and customized, complete solutions to help you bring life-changing drugs to market, faster. We are a leading GMP and GLP testing services provider for the development of your therapeutics. Regulatory bodies such as the US Food & Drug Administrators (FDA) and the Medicines and Healthcare products Regulatory Agency (MHRA) require products to be tested for compliance before release. With locations worldwide, we offers more than 1,000 tests and complementary services related to biologics safety testing and specialized toxicology. For more information, visit www.bioreliance.com.

Fast-Track Drugs and Biologics, LLC is a contract research organization (CRO) providing strategic planning, clinical trial and regulatory support services to the pharmaceutical and biotech industries for the development and licensure of vaccines and therapeutics for human diseases.

Fast-Track's mission and commitment to our clients is to identify the critical path of pre-clinical and clinical studies and to implement projects required to quickly move products through the development process.

Fast-Track's critical path planning approach ensures our clients the most expedient pathway through the regulatory process with the shortest timeline to product licensure.

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

Akston Biosciences Corporation leverages its novel fusion protein platform to develop and manufacture new classes of biologics, including vaccines, ultra-long-acting insulins, and autoimmune disease therapies. Founded by the team that developed the world’s first clinical glucose-responsive insulin at SmartCells, Inc., Akston’s COVID-19 vaccine candidate is in Phase II trials in the Netherlands. It has partnered with Dechra Pharmaceuticals PLC to commercialize once-a-week canine and feline insulin therapies. The company employs 35 people, has over 3,500 ft2 of research laboratory space and a 12,400 ft2 GMP clean room biologics manufacturing facility.

Avitide discovers, develops, manufactures and supplies custom and catalog biopharmaceutical affinity purification solutions to the biopharmaceutical industry. Avitide’s proprietary AVIPure™ affinity ligand portfolio sets the standard for precise affinity separations and consistent robust performance for its high-valued chromatographic products. Avitide develops these technologies with an industry-leading 3-month, concept to resin delivery service timeline that enables industry biopharmaceutical manufacturers and contract developers to achieve faster bioprocess development timelines, improved process economics, predictable scalability, and enable next-generation integrated continuous downstream processing. Avitide’s commercial resin manufacturing and supply operates under an ISO 9001:2015 quality management system and has been successfully audited for its quality systems and continuity of supply plan for its affinity chromatography products. Avitide has successfully deployed affinity purification technologies towards an array of biological molecules including enzymes, bispecific antibodies, therapeutic scaffolds, growth factors, hormones, insulins, blood factors, Fcfusions, cell-based therapies, vaccines, and gene therapy viral vectors. Avitide's management team brings substantial industry expertise and a successful track record in commercializing innovative biopharmaceutical manufacturing platforms. Avitide is financed by premier venture capital and private equity firms, including Polaris Venture Partners, OrbiMed Advisors, Mithril Capital Management, Sands
Capital Ventures, Section 32, SV Health Investors, Borealis Ventures, and NeoMed Management. For more information, visit www.avitide.com.