What is HIVE?

A comprehensive bioinformatics and regulatory analytics platform for all genomic and biomarker data. HIVE has been used by the FDA for regulatory decisions and research projects since 2013.

Trusted Platform

HIVE is the only software with the Authorization to Operate (ATO) for analyzing genomic data in the FDA regulatory review environment and has been used by the FDA for regulatory decisions since 2013.

Now Widely Available

By using HIVE and aligning to FDA bioinformatics standards and protocols, biopharma sponsors expedite their regulatory approvals by months.

Use Case: At this Cell & Gene Therapy biotech client, bioinformatics issues led to a hold by the FDA.

What Happened?

Delayed phase 1 clinical trial by 6 months
Burned ~ $15,000,000 of costs
Lost up to ~ $75,000,000 of revenue

The Embleema Solution

Lifted the FDA hold (accelerated approval by 4 months)
~ $12,000,000 of cost savings
~ $50,000,000 of future revenues added

Scientific Leadership

The HIVE team is a co-author of the IEEE BioCompute standard, a framework for standardizing & sharing computations & analyses which eases the exchange of HTS workflows between the FDA, pharmaceutical companies, contract research organizations, providers & academic researchers. HIVE has published over 40 peer reviewed scientific articles.

The Most Comprehensive, Cloud-Based, Regulatory Analytics Platform in the Industry

Platform Features

Versatile Data Retrieval

Open APIs for third-party system integration

Extensive knowledgebases curated and shared in common with the FDA


Provenance & Standards

Full provenance of data and analytics using BioSample & BioCompute accepted by the FDA

Comprehensive data standardization and harmonization


Sole platform with FDA authorization to operate (ATO) in a regulatory environment

NIST 800 compliant, FISMA-M compliant, HIPAA and GDPR-enabled

CFR21 Part 11

Federal Archive

Federally–approved archival system

Supports long-term storage of scientific data data, analytics, and methods to interpret it

Regulatory Analytics

Comprehensive data standardization and harmonization

Peer-reviewed algorithms and pipelines used by the FDA

Visualizations & Interpretation

Interactive visualizations of terabytes of multi-omics data

Present your data in easily analyzable format

Rapidly address key concerns from the FDA and accelerate your approvals

  • On-target / off-target activity of your cell & gene therapy
  • Manufacturing consistency of your product
  • Compliance to FDA bioinformatics standards and protocols

Establish patient monitoring in line with FDA requirements

Expert Consulting for Confidence in your Data

Differentiated Research and Regulatory Bioinformatics for Life Sciences

Life sciences align with the FDA on their genomic data management, analytics and submission to accelerate NDAs, BLAs and INDs.

Use Case: Viral Vector Therapy Manufacturing Consistency

The FDA Office of Vaccines Research and Review (OVVR) uses HIVE to perform genomic analysis of viral vector product and vaccine batches, “making them significantly safer and more effective.” (*) HIVE detected a pathogenic mutation in a polio vaccine batch (**)

What is the current problem?

Non-comprehensive (miss revirulent genomic mutations of the attenuated virus)

Time consuming
(~6 months)

Cost prohibitive

Raises ethical questions on level of animal testing

The Embleema Solution

HIVE performs a population analysis at genomic level (NGS) of batches of Viral Vector product, providing a significantly more sensitive and comprehensive comparison at molecular level with the reference sample and a less expensive solution for manufacturing consistency.


Fast (1 week)

Analysis accepted by the FDA

Cut back on animal testing

Set-up a more accurate vaccine manufacturing consistency quality-control at genomic level, reducing your dependency on animal-based tests & saving you time and money.

Are you struggling to understand the FDA's requirements for bioinformatics? Are you on FDA hold? Are you about to submit an IND or BLA? We can help.