PackGene Biotech provides end‑to‑end CRO and CDMO services for gene‑therapy development, offering high‑yield AAV, lentiviral, plasmid DNA, and GMP‑grade mRNA/LNP production using its proprietary π‑Alpha 293 platform. Their GMP‑certified facilities support scalable batches from discovery to clinical manufacturing, complemented by vector design, analytical testing, and fill‑finish capabilities.
Funding
$14.1M 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.
CSFounders
Product
Problem
Researchers and biopharmaceutical developers often face bottlenecks in obtaining high‑titer, high‑purity viral vectors, plasmids, mRNA and LNPs at scales required for preclinical studies and clinical trials. Limited manufacturing capacity, variable quality, and high costs delay gene‑therapy programs.
Solution
PackGene Biotech operates as a full‑service CRO and CDMO that provides end‑to‑end production of AAV, lentiviral, plasmid DNA, and mRNA/LNP therapeutics. Its proprietary π‑Alpha 293 high‑yield platform combines an optimized PCS3.0 suspension cell line with engineered RC plasmids, delivering up to 10‑fold higher vector yields (up to 1 × 10¹⁷ vg per batch) and improved purity. The company offers scalable batch sizes from 2 L to 200 L, GMP‑compliant manufacturing, and a suite of analytical and quality‑control assays to ensure consistent potency, low empty‑capsid rates, and regulatory‑ready documentation. By integrating vector design, cloning, production, purification, fill‑finish, and regulatory support, PackGene enables faster, more cost‑effective development of gene‑therapy candidates from discovery through clinical manufacturing.
Target Audience
Primary customers are biopharmaceutical companies and academic research institutions developing gene‑therapy or RNA‑based therapeutics that require viral vectors, plasmid DNA, or GMP‑grade mRNA/LNP at research, preclinical, or clinical scales.
Features
- Proprietary π‑Alpha 293 platform delivering 3–8‑fold higher AAV yields across serotypes, with single‑batch outputs up to 1 × 10¹⁷ vg
- GMP‑certified facilities (120,000 sq ft) offering scalable production volumes (2 L–200 L) for AAV, lentivirus, plasmid DNA, and GMP mRNA/LNP
- Comprehensive analytical services including ddPCR, qPCR, anion‑exchange HPLC, TEM, and endotoxin testing with <5 % %RSD for key assays
- End‑to‑end vector design tools (piVector Designer) and seamless cloning pipelines supporting custom capsid engineering and tissue‑specific promoters
- Rapid turnaround (8–12 business days for lentivirus; 10–25 days for custom mRNA‑LNP) with secure cold‑chain shipping
- One‑stop fill‑finish capability (up to 4,000 vials per batch) and cell‑banking for clinical‑grade material
- Access to a catalog of ~100 AAV serotypes, engineered capsids, and off‑the‑shelf plasmid, lentivirus, and mRNA/LNP products