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.
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.
Halo Labs offers the industry’s first low volume, fluidics-free analytical system designed specifically to address the demand for quantitative subvisible particle measurement in formulation development, stability testing, and process control. The HORIZON system utilizes Backgrounded Membrane Imaging (BMI) technology to enable high throughput particle imaging with automated analysis - making it possible to rapidly detect, quantify, and characterize subvisible vector particle aggregates with multiple conditions in parallel - even when limited material is available.
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.
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.
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.
With vast experience supporting cell and gene therapy manufacturing from early clinical, through process validation, product optimization, and marketed release, Eurofins BioPharma Product Testing provides comprehensive GMP-compliant CMC testing support for cell and gene therapy products to ensure the identity, potency, purity, and safety of starting materials, intermediate products, vectors, and final drug products as well as support for manufacturing process development and validation.