# Industrialization of Antibody-based Contraceptive MPTs

> **NIH NIH P50** · BOSTON UNIVERSITY MEDICAL CAMPUS · 2020 · $1,101,179

## Abstract

PROJECT ONE: ABSTRACT 
The purpose of the Industrialization Project is to manufacture an antibody-based product for use in women to 
achieve contraception. The Human Contraceptive Antibody (HCA) will be formulated in a vaginal film for on- 
demand protection, and in an intravaginal ring (IVR) for long-term protection. The addition of antibody-based 
contraception will be the commercial driver for a more comprehensive future version of MB66 (anti-HIV/HSV), 
an antibody-based multipurpose prevention technology (MPT) that is currently in a Phase 1 safety trial. 
Because of their potency, specificity, and safety profile, human monoclonal antibodies (mAbs) are leading 
candidates for the generation of highly specific, but mechanistically diverse, contraceptive MPTs. 
The industrialization process of HCA (a Contraception Development Research Project) is turning a laboratory 
process into a consistent and well-characterized process that can mass-produce a quality product. The 
challenges involved in successful industrialization are complex, though highly underestimated in the scientific 
community. Fortunately, manufacturing platforms for monoclonal antibodies have made significant technical 
and therapeutic advances over the last several decades. Although each platform may offer some 
manufacturing advantages, only Nicotiana and Trichoderma are likely to be able to address the unmet needs 
of large, cost-sensitive markets like antibody-based contraceptives. The near-term driving factors for the 
Industrialization Project are speed, quality and research costs favoring transient expression of fully assembled 
antibodies in the plant Nicotiana, while the long-term drivers for large, cost-sensitive markets are rapid cycle 
time (days to weeks), low commercial manufacturing cost (<$10/g of DS), and large commercial scale (>10 
metric tons of DS) favoring antibody expression in the fungus Trichoderma. 
The Specific Aims of Project One are: 
1. To manufacture GMP HCA drug substance (DS) in Nicotiana, and an HCA-film (drug product, 
 DP) for preclinical and clinical studies. 
2. To conduct IND-enabling preclinical studies of HCA film. 
3. To develop sustained release capsules of HCA that can be incorporated in to intravaginal rings. 
4. To industrialize low cost and large-scale Trichoderma manufacturing for an antibody-based 
 Contraceptive MPT.

## Key facts

- **NIH application ID:** 9933968
- **Project number:** 5P50HD096957-03
- **Recipient organization:** BOSTON UNIVERSITY MEDICAL CAMPUS
- **Principal Investigator:** Kevin John Whaley
- **Activity code:** P50 (R01, R21, SBIR, etc.)
- **Funding institute:** NIH
- **Fiscal year:** 2020
- **Award amount:** $1,101,179
- **Award type:** 5
- **Project period:** — → —

## Primary source

NIH RePORTER: https://reporter.nih.gov/project-details/9933968

## Citation

> US National Institutes of Health, RePORTER application 9933968, Industrialization of Antibody-based Contraceptive MPTs (5P50HD096957-03). Retrieved via AI Analytics 2026-05-23 from https://api.ai-analytics.org/grant/nih/9933968. Licensed CC0.

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