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.
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.