BIA Separations, with its 20 years of experience in DSP, is fully dedicated to the development of best-in-class analytical and preparative chromatographic solutions within the Gene and Cell Therapy space. Convective Interaction Media (CIM®), utilized in hundreds of clinical batches are setting the standard of manufacturing highly complex ATMPs such as AAVs, pDNAs, mRNAs, Viral Vaccines and Exosomes today. Choosing BIA Separations as a CRO provides you with the best assurance, not only of quality processing, but also the process controls and high product quality you need, in time.
Bio-Rad designs, manufactures, and distributes a broad range of innovative tools and services to the life science research and clinical diagnostics markets. Founded in 1952, Bio-Rad has a global team of more than 7,750 employees and serves more than 100,000 research and industry customers worldwide through the company’s global network of operations.
Covance Inc., the drug development business of Laboratory Corporation of America Holdings (LabCorp), is the world’s most comprehensive drug development company. Covance and LabCorp are at the forefront of the development of cell and gene therapies based on its well-established, unique expertise and coordinated capabilities in scientific, regulatory, and commercial areas across preclinical, clinical, and post-approval phases. We deliver unique perspectives by leveraging the largest volume of drug development and proprietary lab test data in the world.
Beckman Coulter Inc. is one of the world’s leading manufacturers of measuring instruments and test assays in the field of life science and clinical diagnostics. For the discovery and development of new drugs, their production and medical diagnostics, scientists today need state-of-the-art tools and services to investigate complex biological systems and questions. Beckman Coulter Life Science supports our customers from the scientific, biotech and pharmaceutical sectors with a wide range of systems for the analysis of cells, proteins, particles and genomic materials. Whether pipetting robots or centrifuges, devices for cellular analysis or flow cytometry, antibodies for immunological assays or kits for genomic questions - all these solutions help today’s scientists to answer the challenging questions in the best possible way.
Every day, QIAGEN serves 500,000 customers globally, all seeking insights from the building blocks of life – DNA and RNA. Delivering Sample to Insight solutions for molecular testing, we enable scientists and clinicians to achieve breakthroughs in life sciences research, molecular diagnostics and drug development. We make improvements in life possible.
ACF Bioservices is the only analytical CRO exclusively dedicated to supporting CGT. Our CGT bioanalytical services include de novo assay development through Qualification, Validation, and GMP-compliant release testing. We have experience with immunotherapies – ex-vivo, in-vivo, autologous, allogeneic and non-vector mediated therapies. ACF’s nonclinical in-vivo services (GLP or Non-GLP) can be performed for proof of concept, efficacy, toxicity, biodistribution, and shedding. Our in-vitro services (Non-GLP, GLP, GMP) can Develop, Qualify and Validate relative potency assay, stability assay, neutralization antibody assay, vector infectivity (TCID50). ACF is FDA inspected and AAALAC accredited.
PROGEN provides a line of reliable AAV quantification ELISAs for different serotypes utilizing a unique portfolio of capsid-specific AAV antibodies. In addition, the company offers specific antibodies to study AAV assembly and capsid formation as well as to analyze pre-existing AAV immune responses by neutralization assay. The established manufacturer and supplier of exclusive AAV Titration ELISAs and antibodies for gene therapy research and development was founded in 1983 and is located in Heidelberg, Germany.
Wyatt Technology is the recognized leader in light-scattering-based instrumentation and software for the biophysical characterization of nanotherapeutics, determining size and high-resolution size distributions, particle concentration, encapsulation efficiency, empty:full ratio, zeta potential and more. These tools include: multi-angle static light scattering coupled to size-based fractionation—SEC-MALS and AF4-MALS; high-throughput dynamic light scattering; and MP-PALS for automated electrophoretic mobility. Wyatt's training, service and support are widely considered the industry benchmark of excellence.
SCIEX enables drug discovery and development for biologics and small molecule drugs, providing innovative LC-MS, LC-MS/MS and CE solutions that reduce complexity. Your therapeutics have variable molecular complexity and unique analytical needs. You need to make the best decisions quickly, based on data you can trust. SCIEX has a history of pioneering solutions that enable you to succeed in the face of escalating workloads and more complex biotherapeutic characterization demands. Our biologics characterization solutions make it possible to extend your analytical capability, increase lab throughput, streamline complex workflows and automate data processing – simplifying complex characterization processes and making them more accessible.
Osmolality is a valuable analytical tool in gene and cell therapy process development and manufacturing—giving you increased confidence in your process and product quality. Recent publications support downstream raw materials testing and a novel in-process application in purification. Learn more about our latest osmometers designed for process development while seamlessly transferring into GMP with advanced data management features (21CFR Part 11). Join our presentation, hosted by Kendal Studd, Applications Scientist, download application notes and chat with our product experts.
We provide contract development and manufacturing services that enable pharma and biotech companies to deliver medicines to patients. From the building blocks of life to the final drug product, our solutions are created to simplify your outsourcing experience and provide a reliable outcome when you expect it. Our extensive track record includes commercialization of pioneering therapies and manufacturing of a wide variety of therapies. Together, we can bring the next medicine to life.
As novel cell and gene therapies continue to expand, you need a solution that can manage the complete product development process from discovery and development through pre-clinical and clinical research, through post-market safety monitoring. WellSky Biotherapies allows you to build workflows and manufacturing procedures to effectively manage autologous and allogeneic protocols. It expands your ability to centralize and share data through a single system while decreasing batch review, approval, and release times, accelerating understanding of therapeutic outcomes.
Malvern Panalytical is a leading supplier of innovative material characterization solutions for pharmaceutical development and gene therapy. Our toolset addresses the analytical challenges in this field, where biomolecular stability, activity, potency and purity are key product attributes. Our technologies address rapid AAV titer, full:empty ratio, purity, detection and quantification of aggregates and fragments, and stability under thermal stress. Learn more about our dynamic light scattering, SEC-MALS, nanoparticle tracking analysis, SAXS, and microcalorimetry solutions.
Here’s the deal. We’re all about helping researchers break free from tools that just don’t cut it. Unleashing problem-tackling products that make a huge difference in the real science they do every day. Check out Stunner – the ultimate gene therapy tool! Quantifying the empty/full ratio of AAV sucks. Current techniques only quantify bits and pieces of your AAV and require tons of sample, it's a hassle to see which capsids are stuffed with DNA. Stunner combines UV/Vis, DLS and SLS to quickly tell the whole story about your AAV’s titer – label-free, standard-free and hassle-free.
At their core, gene therapies are comprised of nucleic acids, proteins and lipids that need to be fully characterized, and for which precise chemistry, manufacturing and control (CMC) processes must be established to ensure their safety and efficacy. Waters offers a broad set of tools, solutions and expertise in biomolecular separations, mass analysis and biophysical characterization to support the development and commercialization of these new and exciting modalities.
Bio - Techne
Bio-Techne is a global life science company providing innovative products and resources for the research and clinical diagnostic communities. Our expertise across three operating divisions spans laboratory research, preclinical and clinical studies, and reagents for manufacturing therapeutic and diagnostic tests, making us uniquely suited to serve the immune cell therapy research community. We develop and manufacture NK cell isolation and expansion kits, specialized NK cell culture media, and high-quality proteins, and we have established ourselves as the world leader in immunoassays.
Boston Analytical is a cGMP compliant, FDA/DEA registered, ISO/IEC-17025:2005 certified analytical laboratory. We have the latest bioanalytical equipment and can help with peptide, protein, and oligonucleotide analysis and characterization under guidance documents such as ICH Q6B. Boston Analytical offers compendial methods as well as methods developed specific to your products. Boston Analytical offers compendial methods as well as methods developed specific to your products.
BioIT Solutions delivers highly adaptable data management and workflow systems ready-made for today’s fast paced Biotech laboratory. Streamline your operations with BioIT Solutions’ 1PLATFORM4 Process Development and Analytical Testing Software Suite. We combine our IT expertise gained from decades of experience in the biopharmaceutical industry with our flexible 1PLATFORM4 Software Suite to provide solutions that are rapidly deployed and customized in a cost-effective manner.
Siemens Healthcare Laboratory
Siemens Healthcare Laboratory is CAP accredited, CLIA licensed laboratory based in Berkeley CA and is a part of Siemens Healthineers. SHL offers end-to-end diagnostic services and solutions which includes viral vector shedding, infectivity, and neutralizing antibody development services for biopharmaceutical gene-therapy therapy development programs. Our services range from biomarker discovery, development, acquisition, and set-up of clinically validated technologies for clinical trials and patient testing to the introduction of new laboratory diagnostic tests and IVD predevelopment.
Halo Labs knows stability and particles. The Aura, our flagship product, can count and characterize subvisible particles - and tell you whether they are aggregated viral capsid, or external contaminants. A simple, plate-based approach enables low-volume (5µL), high-throughput, fully automated particle imaging and analysis at any stage from developability assessment through quality control.
Gyros Protein Technologies
Gyros Protein Technologies provides enabling peptide synthesis and bioanalytical solutions, helping scientists in research through bioprocess applications. Our peptide synthesizers and chemistries deliver uncompromising purity, flexibility and quality in less time. Sensitive, accurate and robust nanoliter-scale immunoassays for pharmacokinetics/pharmacodynamics, immunogenicity and quantitating bioprocess impurities and viral titer are performed on our proprietary platforms [Gyrolab™ xPand and Gyrolab xPlore™]. Peptide synthesis and bioanalytical solutions: accelerate your discovery, development and manufacturing of safer biotherapeutics. Gyros Protein Technologies is a division of Mesa Laboratories.