# Core B: Industrialization Core

> **NIH NIH U19** · ALBERT EINSTEIN COLLEGE OF MEDICINE · 2020 · $181,343

## Abstract

ABSTRACT: CORE B
Monoclonal antibodies (mAbs) are one of the most successful classes of drugs with the proven ability to
address a variety of human health needs ranging from oncology, inflammatory diseases, and infectious
diseases. Recent studies have demonstrated efficacy of mAbs against the most virulent infections
including Nipah, Hendra, Ebola, Marburg and Lassa. Antibodies isolated from human survivors, the
focus of the Prometheus CETR, have the advantage of having been a component of a successful host
response to a pathogen. Further, these mAbs were positively selected for by the human immune
response to the target pathogen. Therefore, these survivor mAbs will have an increased chance of
being safe and efficacious compared to mAbs generated from other platforms. MAbs also offer a
stunning degree of customization based on the importance of mechanisms of action. Different classes,
sub-types, point mutations and N-glycosylation states can dramatically impact the potency of a
prophylactic or therapeutic mAb candidate. The manufacturing platforms, formulation methods, and
safety profiles of mAbs are well-established. Thus, mAbs offer a low-risk technology platform for
prophylactics and therapeutics for the Category A threats (i.e. agents that pose the highest risk to
national security and public health) to be addressed by the Prometheus CETR. Core B, in conjunction
with Research Project III, will also evaluate the use of DNA-encoded mAbs (DMAbs), a potentially
transformative technology that turns the patient’s own muscle cells into mAb producers.
The Industrialization Core (Core B) is focused on ensuring the down-selection process of the CETR
results in: 1. Manufacturable mAbs; 2. A product that satisfies the Target Product Profile (TPP); 3. Data
sets and materials (e.g. cell banks) that are appropriate and supportive of regulatory filings with the
Food and Drug Administration (FDA) to transition the products into advanced development. The
Industrialization Core has two Aims: 1) Provide product development experience to Research Projects
and the Cores to assure studies are compatible with industry and regulatory expectations, and 2)
Transition products to advanced development.

## Key facts

- **NIH application ID:** 9872997
- **Project number:** 5U19AI142777-02
- **Recipient organization:** ALBERT EINSTEIN COLLEGE OF MEDICINE
- **Principal Investigator:** Kartik Chandran
- **Activity code:** U19 (R01, R21, SBIR, etc.)
- **Funding institute:** NIH
- **Fiscal year:** 2020
- **Award amount:** $181,343
- **Award type:** 5
- **Project period:** — → —

## Primary source

NIH RePORTER: https://reporter.nih.gov/project-details/9872997

## Citation

> US National Institutes of Health, RePORTER application 9872997, Core B: Industrialization Core (5U19AI142777-02). Retrieved via AI Analytics 2026-05-23 from https://api.ai-analytics.org/grant/nih/9872997. Licensed CC0.

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