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.
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.
Vironova is a Swedish biotechnology company providing comprehensive, hardware, software, and services for the analysis of nanoparticles. Vironova revolutionizes access to transmission electron microscopy–based image analysis in biopharmaceutical development. Our solution enables automated analyses for faster and better informed decisions to secure robust bioprocessing and final product quality.
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.
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.
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.
Brammer Bio is dedicated to providing clinical and commercial viral vectors for in vivo gene and ex vivo gene-modified cell therapies, from process and analytical development through commercial approval. We have a highly skilled team of scientists with expertise from over 100 client projects to tackle the challenges posed by these novel technologies and help accelerate their transition from the clinic to patients, while focusing on meeting cGMP standards. Brammer Bio is Helping to Cure.®
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.
Isoplexis is dedicated to the fight against cancer and the world's toughest diseases with its award-winning single-cell detection systems. By revealing unique immune biomarkers in small subsets of cells, we advance immunotherapies and targeted therapies to a precise, personalized stage. IsoPlexis systems advance the field of single-cell biology and biomarkers creating solutions to overcome the challenges of complex diseases.
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.
Advanced Instruments recognizes the need for reliable process parameters in gene and cell therapy production. Our osmometers can support workflow optimization in cell culture (increasing yield and reducing aggregation), viral vector purification, buffer QC, and formulation. The OsmoTECH® Single-Sample Micro-Osmometer and OsmoTECH® PRO Multi-Sample Micro-Osmometer provide valuable concentration measurements while delivering robust data management, operational efficiency, ease of use, and compliant features (GMP, 21 CFR Part 11, EU Annex 11).