Naobios is a GMP‑certified CDMO that provides end‑to‑end bioprocess development and manufacturing for virus‑based products, including viral vectors, live or inactivated vaccines, oncolytic viruses, and human viral challenge agents. It offers scalable upstream and downstream processes in dedicated BSL‑2/3 suites, integrated analytical testing, and optional fill‑and‑finish to support preclinical through clinical batch production.
Funding
$1.8M raised to dateRaised to date based on public sources. This may differ from the amount the company actually raised and is based only on what is publicly available on the internet.
Founders
Product
Problem
Developing and manufacturing viral-based therapeutics and vaccines requires specialized bioprocess development, GMP‑certified production, and rigorous quality control, especially for BSL‑2/3 pathogens. Access to facilities that can scale from preclinical to clinical batches while ensuring regulatory compliance is limited.
Solution
Naobios operates as a contract development and manufacturing organization (CDMO) focused on virus‑based products, including viral vectors, live and inactivated vaccines, oncolytic viruses, and human viral challenge agents. The company provides end‑to‑end services: custom upstream and downstream process development using Design of Experiments, scale‑up in single‑use or fixed‑bed bioreactors up to 250 L, and GMP‑compliant manufacturing in dedicated BSL‑2 and BSL‑3 suites. Integrated analytical development and validation ensure product identity, purity, potency and safety, while in‑house quality control and partnership with Clean Cells cover release testing and regulatory documentation. Clients receive scalable, transferable processes that can progress from preclinical material to investigational medicinal product (IMP) batches for Phase III studies, with optional fill‑and‑finish and challenge‑agent production for CHIM studies.
Target Audience
Primary customers are biotech and pharmaceutical companies developing viral vaccines, viral vectors, oncolytic viruses, or viral challenge agents that require GMP‑grade manufacturing and process development support.
Features
- Dedicated GMP‑certified BSL‑2 and BSL‑3 manufacturing suites (grade D to B) for safe handling of high‑risk viruses
- Upstream development on suspension or adherent cells using static containers, microcarriers, single‑use bioreactors (up to 250 L) and iCELLis fixed‑bed systems (up to 500 m²)
- Downstream purification with TFF, chromatography (AKTA Explorer/Pilot/Pure), and filtration systems for virus concentration, impurity removal and inactivation
- Design‑of‑Experiments (DOE) driven process optimization and media screening for high yield and purity
- Full analytical development and validation (ICH Q2(R1) compliant) covering identity, potency, purity and safety, performed in‑house or via Clean Cells
- Scalable, single‑use platform enabling seamless transfer from early‑stage to clinical and commercial production
- Capability to manufacture human viral challenge agents and oncolytic viruses for CHIM studies and cancer immunotherapy