HIVE provides a full range arsenal of native and adopted tools and pipelines that allow regulatory and research scientists to generate, store, QC and analyze genomic datasets using a variety of web-driven visual interfaces tailor made for manipulating petascale multi-omics information pertinent to medical product evaluation evidence.
Multi-omics algorithms
HIVE was created as a platform for FDA to accept, archive and analyze genomics big datasets that are submitted to FDA as a part of the evidence for medical product evaluation. HIVE is the only big data, -multi- omics ready ecosystem that has been authorized by federal government to be used in regulatory healthcare context. As such, it has a full range arsenal of native and adopted tools and pipelines that allow regulatory and research scientists to generate, store, QC and analyze genomic datasets using a variety of web-driven visual interfaces tailor made for manipulating petascale multi-omics information. Aligners, germline and somatic variant callers, de-novo assemblers, differential profiling utilities, clusterization, classification methodologies for genotype-phenotype correlations, and artificial intelligence driven pattern recognition algorithms are robust instruments that are used by HIVE experts to assist in preclinical, clinical and post-market research.
Gene/Cell therapy product
Advent of novel onco-diagnostics and immuno-oncology therapeutic products would not be possible without FDAs capacity to retrieve and analyze genetic datasets produced by pharma and biotech for target identification, MOA validation, translational research, clinical validation, and product characterization. Federal government relies on our HIVE technology platform and on standard operating protocols developed by our experts to handle datasets for cell and gene therapy products in oncology, immune oncology, hematology, and microbiome therapies. Expertise and tools are available in HIVE that enable evaluation of allogeneic and autologous gene- edited products, product characterization, and on-target and off-target analysis, single-cell and subpopulation level consistency of T-, B- and NK-cell derived immune cell products.
Product manufacturing consistency
Variety of medical products such as live attenuated vaccines, viral delivery gene therapies and gut microbiome adjustment therapies rely on bioengineered live products for immune system activation, gene delivery and healthy biome composition adjustment. Such products are volatile and quality by design considerations for manufacturing consistency can only be truly achieved through molecular level monitoring of product passages and batches. HIVE experts have designed set of protocols and procedures for FDA use and provide similar services to industry to ensure regulatory compliant manufacturing consistency monitoring infrastructure for genetic drift of live viral products, for microbiome and metagenomic stability of bacterial products.
