HIVE-CMC Manufacturing Consistency

The Manufacturing Development of Complex Biological Medicinal Products is Under Increasing Scrutiny by Regulators

HIVE-CMC enables sponsors to meet stringent FDA quality guidelines throughout the entire process development workflow to optimize purity and safety

Summary Report

Summary results are shareable with the FDA in native HIVE Pack format through the dnahive.fda.gov portal

Sequencing Retrieval

FASTA Files

FASTQ Files

Sequencing QC

Nucleotide & Phred QC Profiling

Sequencing Census

Codonoic QC & Complexity QC

Sequencing Alignment Variant Calling

 Alignment (SAM/BAM)

Consensus on Reference

Mutation and in-del profiling

Clonal Subpopulation Analysis

List of all clones with coverage distribution

Extensive analysis of every clone

Annotation Mapping

Mapping of all mutations, in-dels, and clonal bifurcation points

Functional annotations of variations


HIVE CMC Suite


HIVE – Viral Product

Enables sponsors to meet stringent FDA quality guidelines by implementing controls for detection of genetic drift for viral and vaccine products. This ultimately results in optimization of purity and safety of the products.

HIVE – Cell Therapy

Enables sponsors to characterize quality of cells by monitoring RNA expression of subpopulations of immune cells at a single cell genomic level. It also provides ability to monitors cells in-vivo for post-market evaluation of cell therapy products.

HIVE – Stem-Cell Therapy

Enables sponsors to characterize cells by monitoring RNA, and microRNA expression of subpopulations of immune cells at a single cell genomic level. It provides ability to select higher quality batches of volatile product with better safety and efficacy profile.

Realize the Benefits of HIVE CMC


Get Faster and More Accurate Results

Reduce Animal Testing

Align with the FDA

Contact us and schedule a demo.