Bioanalytical Services 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 end-to-end integrated services, from product development through commercial manufacturing and packaging, with expertise in complex oral formulations. Adare's specialized technology platforms provide taste masking, controlled release, solubility enhancement, and patient-centric dosing solutions. With a proven history in drug delivery, Adare has developed and manufactures more than 45 products sold by customers worldwide.
Capabilities
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
August Bioservices is a growing, US-based CDMO, focused on sterile injectable formulation and fill/finish cGMP manufacturing — optimizing liquid and lyo products, aseptic or terminally sterilized — at both clinical and commercial scale. As a "one stop CDMO shop," we offer turnkey, end-to-end services, and integrated project teams all onsite, under one roof.
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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.
Cambrex
Cambrex is a leading global contract development and manufacturing organization (CDMO) that provides drug substance, drug product, and analytical services across the entire drug lifecycle. With over 40 years of experience and a growing team of over 2,200 experts servicing global clients from North America and European sites, Cambrex is a trusted partner in branded and generic markets for API and dosage form development and manufacturing.
Catalent
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.
Capabilities
Jefferson Institute for Bioprocessing (JIB)
With the mission of providing state-of-the-art education, training and contract services in the fast-emerging field of biopharmaceutical processing, Jefferson Institute for Bioprocessing (JIB) formally opened its doors in 2019 and is the first—and only—specialized education, training and CDMO for biopharmaceutical processing in North America. JIB's 25,000 sq. ft fully closed-processing, CNC, GMP-simulated pilot scale and process development facility houses ready-to-use technologies in fully flexible, ballroom designed suites.
Kymanox Corporation
Kymanox is a life science professional services organization that offers engineering, scientific, and compliance support to companies exclusively in the biotechnology, pharmaceutical, medical device, and combination product industries. With its diverse team, Kymanox helps clients navigate commercialization challenges that arise throughout a product's lifecycle – from early development to post-market commercialization – with optimized safety, quality, efficacy, and accessibility.
MilliporeSigma
Our team of experts will consult with you to develop your specific testing program from our wide array of routine and platform assays to fully characterize and analyze your AAV vector's safety, identity, quality, purity, potency, and stability.
Capabilities
Precision NanoSystems
Precision NanoSystems is a global leader in technologies, solutions and services for the development of Lipid Nanoparticle delivered genomic medicines, including mRNA vaccines and therapeutics. We support (bio)pharma companies who are ushering in the next wave of genomic medicines in infectious diseases, cancer and rare diseases. We work with the world's leading drug developers to understand disease and help create the therapeutics and vaccines that will define the future of medicine.
Capabilities
Pyxant Labs
Navigating a robust regulatory environment, advancing your development program with speed, and accessing a breadth of technical expertise are all critical factors to the success of your program. Pyxant Labs and ImaBiotech provide a range of bioanalytical lab, spatial bioanalysis, and spatial biology solutions. As a result, we will help you advance your molecule from discovery through clinical development and NDA approval.
Quotient Sciences
Quotient Sciences is a drug development and manufacturing accelerator providing integrated programs and tailored services across the entire development pathway for small molecule & peptide drug programs. Cutting through silos across a range of drug development capabilities, we save precious time and money in getting drugs to patients.
Rentschler Biopharma
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.
Capabilities
Resilience US, Inc.
Resilience is a manufacturing and technology company dedicated to broadening access to complex medicines and protecting biopharmaceutical supply chains against disruption. Founded in 2020, the company is building a sustainable network of high-tech, end-to-end manufacturing solutions with the aim to ensure the medicines of today and tomorrow can be made quickly, safely, and at scale. Resilience seeks to offer regulatory capabilities and flexible and adaptive facilities to serve partners of all sizes.
Syngene International
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.
Capabilities