# NovaAPI: Terminal Sterilization of Drug Substances and Products

> **NIH NIH R44** · NOVASTERILIS, INC. · 2024 · $860,611

## Abstract

PROJECT SUMMARY / ABSTRACT
NovaSterilis, Inc. intends to develop and commercialize its novel sterilization platform based on supercritical carbon
dioxide (scCO2) and powerful sterilant, NovaKill™ for the pharmaceutical market – NovaAPI™. Sterilization of drug
substances (or active pharmaceutical ingredients; APIs) and drug products is a challenging application due to the
complexities of many drugs and biologics and the minimal compatibility of current sterilization modalities (e.g., steam,
radiation, ethylene oxide). Sterilization in the pharmaceutical industry is typically reserved only for drug substances that
move onto final assembly (i.e., aseptic processing and packaging), which does not provide the level of protection of
sterilization. Products intended to be sterile should be terminally sterilized in their final container whenever possible
(referred to as terminal sterilization) according to the FDA. However, there are very few drug products that utilize terminal
sterilization, and with respect to drug products in sealed containers (e.g., lyophilized drugs or formulated drugs) or
prefilled syringes, the only option for drug companies is to use aseptic processing for final assembly of these products,
which is a time consuming and resource heavy process. While the global sterilization services market for drugs is significant
at roughly $6 billion USD, offering solutions to drug manufacturers for terminally sterilizing drug containing end products
would be a game changer. The global prefilled syringe market alone is estimated to be $5.4 billion USD by the end of 2021,
and currently, the only solution for final assembly of these products is through aseptic processing. This represents a
significant opportunity for the NovaSterilis NovaAPI™ solution, with the potential for enormous upside in providing safer
products, eliminating the need for aseptic processing for process-compatible products and expanding on the number and
type of drug substances/products that can be terminally sterilized.
Previous research results support continued development of the NovaSterilis platform for sterilization of drug substances
and products with the potential for developing a terminal sterilization process for final drug products in vial/syringe
format. We have partnered with a global leader in sterilization services for the broader program, which should provide
significant application, customer, and market insight to the project. iFyber has proposed the following Specific Aims in this
Fast Track proposal to prepare NovaAPI™ for commercialization:
Phase I Specific Aims:
 · Aim 1: Establish a drug substance compatibility matrix for a select number of drugs using NovaAPI™
 · Aim 2: Establish baseline conditions for terminal sterilization of end products
Phase II Specific Aims:
· Aim 3: Complete assessment of sterilization validation process for SAL 10-6 for drug substances/products.
· Aim 4: Complete sterilization residuals testing following regulatory guidelines.
·...

## Key facts

- **NIH application ID:** 10976481
- **Project number:** 4R44AI170431-02
- **Recipient organization:** NOVASTERILIS, INC.
- **Principal Investigator:** Aaron D Strickland
- **Activity code:** R44 (R01, R21, SBIR, etc.)
- **Funding institute:** NIH
- **Fiscal year:** 2024
- **Award amount:** $860,611
- **Award type:** 4N
- **Project period:** 2022-07-11 → 2025-12-31

## Primary source

NIH RePORTER: https://reporter.nih.gov/project-details/10976481

## Citation

> US National Institutes of Health, RePORTER application 10976481, NovaAPI: Terminal Sterilization of Drug Substances and Products (4R44AI170431-02). Retrieved via AI Analytics 2026-05-24 from https://api.ai-analytics.org/grant/nih/10976481. Licensed CC0.

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