Abzena

Abzena is a global integrated solution and proprietary technologies company to enable the development and manufacturing of biopharmaceutical products.

• Contract synthetic chemistry and bioconjugation research services, focused on antibody-drug conjugates (ADCs)
• Proprietary site-specific conjugation technologies and novel payloads for ADC development; and GMP manufacturer of ADC linkers, payloads & combined linker-payloads
• Immunology research studies, including immunogenicity assessment of candidate biopharmaceutical products
• Protein engineering to create humanized antibodies and deimmunised therapeutic proteins
• Cell line development for the manufacture of recombinant proteins and antibodies
• Contract process development and GMP manufacture of biopharmaceuticals, including monoclonal antibodies and recombinant proteins for preclinical and clinical studies

Adesis [ company website ]

Adesis, Inc. is a US-only operated non cGMP chemistry CRO. We specialize in small molecule syntheses involving heterocycle chemistry, stable isotopes, reference standards, impurity syntheses, metabolite syntheses and advanced intermediates in mg to multi kg scale. Adesis has scientific depth with staffing versatility with over 55 chemists (80% Ph.D.) split 50/50 between discovery chemistry and process/scale-up chemistry. Our versatile 47,000 sq ft facility is designed to be flexible to accommodate the needs of our clients. We have 25 years of proven performance with a 99% project success rate supporting three areas: early stage research, scale up and development, and specialty manufacturing.

Advinus Therapeutics Ltd. [ company website ]

Advinus Therapeutics is a premier Contract Research Organization. Our Chemistry Services support discovery, pre-clinical and early clinical development programs. We provide services in Medicinal Chemistry, Custom Synthesis, Process Research and Development. We expertise in focused Library Synthesis to gram scale synthesis for efficacy and toxicology studies, to multi kilogram scale cGMP scale-up for early clinical development. These services are provided on both fee-for-service (FFS) and full-time equivalent (FTE) basis. Our best-in-class infrastructure, QP-audited cGMP facility and competence in discovery chemistry and process research enable us to develop cost-efficient, environment friendly, safe and robust processes that can lead to development of drug candidates for timely delivery.

Almac Sciences

Alphora Research / Eurofins Alphora [ company website ]

Eurofins Alphora provides API technology development services for complex niche small molecules, covering pre-clinical to Phase III and commercial manufacturing. Alphora operates FDA-approved facilities totalling 51,000+ ft² including cGMP Kilo Laboratories and cGMP Plant operations, R&D and Analytical laboratories, QC/QA, as well as a separate high potency/cytotoxic facility.

AMRI [ company website ]

AMRI, a global contract research and manufacturing organization, partners with the pharmaceutical and biotechnology industries to improve patient outcomes and quality of life. With locations in North America, Europe and Asia, AMRI's team combines scientific expertise and market-leading technology to provide a complete suite of solutions in Discovery, Development, Analytical and Solid State Services, API Manufacturing and Drug Product. The key contact is customerservice@amriglobal.com

Anton Paar USA

APC Ltd [ company website ]

APC Ltd is an award-winning and rapidly growing science and technology driven CMC development and innovation company. Our technology, capabilities, and team help our global biopharmaceutical partners accelerate the development and launch of their medicines. Our vision is to make APC the go to place for pharmaceutical and biotech R&D, and ultimately help patients gain access to their medicines in a quicker, safer, more reliable, and cost-effective manner. APC operates from a world-class pharmaceutical and biotech R&D facility in Dublin, Ireland. This state of the art facility enables APC to bring together unique technology with a world class team of scientists and engineers to pioneer innovation in the sector. APC partner with 8 of the top-10 pharma and 5 of the top-10 biotech firms in the world.

Areas of specialty include:

• Chemical and Bioprocess Design & Optimization
• Batch & Continuous Process Design
• Clinical Process Development
• Post Launch Optimization and 2nd Gen Improvements
• Regulatory Compliant NDA Data Sets
• Chemical & Bio-Process Engineering

Asymchem

Avara Pharma Services [ company website ]

Avara Pharmaceutical Services delivers world class contract manufacturing and technical services to the biopharmaceutical market. Our experience with supply chain, commercialization, product launch and product transfer allows us to sustain exemplary levels of product quality and regulatory compliance. We pride ourselves on our outstanding level of customer service. In addition, we are driven to deliver, your brand, on time, in full and at a fair price. Our extensive experience of supply ranges from the U.S. to international markets. Our Manufacturing and Packaging capabilities include oral solid dosage, API, packaging and a high-containment module.

Avista Pharma Solutions [ company website ]

AVISTA PHARMA SOLUTIONS is a leading US based CDMO known for offering scientifically differentiated solutions with expertise in Drug Development and GMP Manufacturing from Discovery through Proof of Concept. Avista is known for helping clients overcome difficult analytical, formulation and process challenges, while offering these services as standalone or bundled from our three locations (Agawam, MA – Durham, NC – Longmont, CO). For more information on how we can help you overcome your next challenge; contact us at avistapahrama.com.

• Drug Discovery
• Analytical Development/Validation
• Process Chemistry
• Solid State/Preformulation/Formulation Expertise
• API/DP Manufacturing
• Stability Storage/Testing
• Microbiological Testing/Cleanroom Services
• Impurity ID/Extractables & Leachables/Elemental
• Impurities/PGI testing

AXYNTIS

Axyntis, French CMO with 6 GMP manufacturing sites in France, offers a broad range of chemistry and technologies, making it a reliable partner, with experienced teams.