Bioanalytical Services CMO Sourcing Center
A lack of – but severe need for – bioanalytical services to support cell and gene drug and therapy development programs is one of the biggest complaints heard from biotechnology companies of all sizes.
As batch sizes, one-off treatments and personalized medicine require frequent product changes, timelines and even clinical trials are also compressed. A wide variety of bioanalytical support services from an early stage of development is critical to move programs forward to commercial success. Services include analytical method development, transfer and validation on a variety of different platforms, and requiring biochemistry, molecular biology, cellular biology, and QC experience.
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Bioanalytical Services CMOs
Adare Pharma Solutions
Adare Pharma Solutions is a global technology-driven CDMO providing turnkey product development through commercial manufacturing expertise focused on oral dosage forms for the Pharmaceutical, Animal Health, and OTC markets. Adare’s specialized technology platforms provide taste masking, ODTs, and customized drug-release solutions. With a proven history in drug delivery, Adare has developed and manufactured more than 40 products sold by customers in over 100 countries globally.
Ajinomoto Bio-Pharma Services
As a leader in small molecule manufacturing, Ajinomoto Bio-Pharma Services has over 40 years of experience providing high quality APIs and intermediates for pharmaceutical companies throughout the world.
August Bioservices is a US-based CRO/CDMO, offering a full range of drug discovery, drug development and drug manufacturing capabilities from preclinical to commercialization and many steps in between. August Bioservices is a team of highly experienced life science experts providing rigorous research, pharmaceutical development, and manufacturing services to clients in the pharmaceutical and biotechnology space.
BD Medical - Pharmaceutical Systems
BD Medical - Pharmaceutical Systems is a global leader in supplying the pharmaceutical industry with innovative, high-quality, clinically-proven and customized pre-fillable parenteral drug delivery systems. Our offering includes an extensive portfolio of pre-fillable syringes, self-injection systems, safety and shielding solutions. Our products are designed to protect, package, and deliver drug therapies and to maximize healthcare worker and patient safety.
Catalent is a global leader in providing integrated services, superior drug delivery technologies and manufacturing solutions to help life science innovators develop and launch successful pharmaceuticals, biologics and consumer health products.
IDT Biologika is a contract development and manufacturing organization offering services for partners committed to the development and marketing of therapeutic and prophylactic vaccines and other biological products. Focused on viral live vaccines and other biopharmaceuticals such as recombinant proteins and monoclonal antibodies, IDT Biologika utilizes state-of-the-art facilities and offers many years of experience in the development of production processes and commercial manufacturing.
JOINN Biologics can take your project from "Digital DNA to final drug product in a vial" all under one roof. We have our own proprietary JOINN CHO-K1 cell line and we are currently validating a Bosch & Strobel vial filling line. Using our new ambr 250, we can optimize your cell culture conditions prior to scale-up for cGMP production of clinical stage bio-therapeutics.
Northway Biotech, an end-to-end CDMO supports biopharmaceutical customers worldwide. Its highly experienced team executes projects from cell line construction and process development to cGMP manufacturing. The company's wide-ranging expertise and vertically integrated service offering translate to the ability to rapidly execute multiple projects from its state-of-the-art GMP facilities while ensuring full process and product compliance at all stages of research, development, and commercial manufacturing.
Ology Bioservices® is now part of Resilience (National Resilience, Inc.). Resilience is a first-of-its-kind manufacturing and technology company offering a network of high-tech, end-to-end manufacturing solutions including production of cell and gene therapies, viral vectors, oncolytic viruses and vaccines. Resilience offers the highest quality and regulatory capabilities with support from IND through Licensure, along with flexible and adaptive facilities to serve partners of all sizes.
Rentschler Biopharma, a global leading CDMO, is your outsourcing partner of choice for bioprocess development and cGMP manufacturing. With almost 50 years of proven scientific expertise, we guarantee best-fit solutions for clinical and commercial supply. Our commitment is reflected in our exceptional client-oriented project management and regulatory support. We are headquartered in Laupheim, Germany, with a second site in Milford, MA, USA.
Syngene's Large Molecule Bio Analytical Laboratory is India’s premier GLP certified and GCLP compliant lab specializing in immunogenicity and pharmacokinetic (PK) analysis of biologics and biosimilars. The laboratory has extensive experience in working with monoclonal antibodies, recombinant proteins, enzymes, biomarkers, cytokines, vaccines and growth hormones during the early and late phases of the drug development (preclinical and clinical) process.