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NeuExcell’s NXL-004 Secures FDA Orphan Drug Designation for Glioma Treatment
On December 7, 2023, Beijing time, NeuExcell Therapeutics announced that its proprietary AAV gene therapy product, NXL-004, designed for treating malignant glioma, has been awarded Orphan Drug Designation (ODD) by the U.S. Food and Drug Administration (FDA). This...
PackGene Biotech Receives Exclusive C+ Round Investment from SDIC Fund, and Hosts a CGT Industry Salon to Discuss Global Strategies
December 1, 2023, PackGene Biotech, a frontrunner in gene therapy delivery, has successfully closed a landmark C+ funding round, securing over 100 million RMB exclusively from SDIC Fund Management Co., Ltd. This funding, a remarkable accomplishment in the current...
Tauopathy’s Role in Aβ Oligomer Formation: New Insights from Transgenic Primate Models on Alzheimer’s Pathogenesis
Tauopathy, characterized by protein tau and Aβ oligomer accumulation, is a significant aspect of Alzheimer's disease. The causal relationship between these accumulations and neurodegeneration remains unclear despite their links to various cognitive and movement...
Targeted Lysosomal Degradation of Mutant Huntingtin by Engineered Intrabody Peptide SM3
Huntington's disease (HD) is a devastating neurodegenerative condition caused by a mutation in the Huntingtin gene (HTT). This leads to the production of a mutant form of the huntingtin protein (mHTT) with an extended polyglutamine (polyQ) repeat, which has a...
Researchers Unveil a Novel Strategy for Protein Miniaturization in the CRISPR-Cas System
In a groundbreaking study published in Nature Communications, a team of researchers from China have introduced an innovative approach to protein miniaturization within the gene-editing realm of the CRISPR-Cas system. The CRISPR-Cas system is celebrated for its...
PackGene Biotech and Kudo Biotechnology Partner to Offer Customized mRNA Manufacturing Services
Collaboration provides end-to-end coverage of mRNA drug and vaccine development and manufacturing workflow HOUSTON, TX and NEEDHAM, MA – PackGene Biotech (PackGene) and Kudo Biotechnology (Kudo Bio) have partnered to provide high-quality, customized messenger RNA...
Zolgensma’s Success in SMA Treatment Advocates for AAV-based Gene Therapy and Promises a Bright Future for Genetic Disorders
At the 2023 Muscular Dystrophy Association Clinical and Scientific Conference, Novartis presented new data highlighting the continued efficacy and durability of its gene therapy treatment, Zolgensma, in treating spinal muscular atrophy (SMA). Zolgensma has been shown...
International Rare Disease Day | PackGene GMP plasmid is DMF registered, helping drug applications and shining lights on rare disease therapy!
February 28th is the 16th International Rare Disease Day with the theme of "Shine lights on your life" . Rare diseases, also known as "orphan diseases", have a low incidence rate and multiple disease types. Most of them are chronic, lifelong, severe, and...
ASGCT (Maryland, May 4-11, 2024)
Abstract:Welcome to ASGCT 2024, the American Society of Gene and Cell Therapy's flagship conference. Esteemed researchers, clinicians, and industry leaders converge at this influential event to navigate the forefront of gene and cell therapy. In the vibrant atmosphere...
American Academy of Neurology (Colorado, Apri 13-18, 2024)
Abstract:The American Academy of Neurology Conference 2024 in Denver, a pivotal gathering for the brightest minds in neurology. This esteemed event brings together experts, researchers, clinicians, and innovators from around the globe to explore the forefront of...
Advanced Therapies Congress (London, Mar 19-20, 2024)
Abstract:The Advanced Therapies Congress convenes leaders in cell and gene therapy development across diverse sectors: pharma, biotech, startups, researchers, clinicians, academics, HTAs, payers, and regulators. In 2024, our new Gene Editing Track highlights CRISPR...
MDA (Florida, Mar 3-6, 2024)
Abstract:The Muscular Dystrophy Association (MDA) holds the top spot as the leading voluntary health organization in the United States, catering to individuals grappling with muscular dystrophy, ALS, and associated neuromuscular conditions. For over 70 years, MDA has...
Webinar: Overcoming Challenges in Preclinical NHP and Large Animal Studies for AAV-Based Gene Therapy through Improved AAV Purification and Quality Control Strategies
Abstract:Are you currently involved in the development of AAV-based gene therapy, specifically with non-human primates (NHP) or other large animals? Whether your focus is on constructing disease models or conducting pre-IND safety and toxicity studies, there are...
Webinar: Quality Delivery of mRNA – LNP with An Unbeatable Timeline
Abstract:Kudo Biotechnology is a global mRNA CDMO company headquartered in Singapore, providing world-class end-to-end cGMP manufacturing solutions for your mRNA needs. Kudo streamlines the manufacturing process of plasmid DNA, mRNA, lipid nanoparticle (LNP) and...
ESGCT 30th ANNUAL CONGRESS BRUSSELS
Time: 24-27 Oct 2023Address: Maison de la Poste, Bruxelles, Brussels, BelgiumContact: Irene Song (Sr. Director, Global Product) irene.song@packgene.comPoster P149:Generation of novel AAV serotype with enhanced infectivity, specificity, and lower toxicity via π-Icosa...
Meeting on the Mesa
Time: Live partnering meetings October 10-12; Virtual partnering meetings October 17-18Address: Park Hyatt Aviara, Carlsbad, CAContact: Luyan He(Head of Commercial Team) Luyan.He@packgene.com
Nanoscope Therapeutics Eyes FDA Approval After Gene Therapy Trial Success
In a significant advancement for retinitis pigmentosa treatment, Nanoscope Therapeutics announced positive outcomes from its Phase IIb trial of MCO-010, a pioneering gene therapy, on Tuesday. The company is now gearing up to seek FDA approval later this year, marking...
New FDA Guidance Impacts the CAR-T Industry
In January, the FDA published, “Considerations for the Development of Chimeric Antigen Receptor (CAR) T Cell Products: Guidance for Industry.” To find out how this guidance impacts the CAR-T industry, GEN talked with Klara Sochorová, PhD, senior quality compliance...
Blackstone to Fund up to $750M for Moderna’s Flu Program
Blackstone entered a new collaboration with Moderna, Inc. through a development and commercialization funding agreement where funds managed by Blackstone Life Sciences will provide up to $750 million to fund Moderna’s influenza program. Under the agreement, Blackstone...
Brazil aims to manufacture its own cell therapies — at a fraction of the current cost
Brazil’s Ministry of Health is working with a US nonprofit to locally manufacture CAR-T therapies and potentially other cell and gene therapies at a much lower cost. The goal is to provide cell therapy free of charge to patients while charging Brazil’s health system...
Successful First Patient Dosing of AAV-NeuroD1 Gene Therapy for Glioblastoma by NeuExcell Therapeutics
Recently, the first patient dosing of NXL-004, an AAV-NeuroD1 gene therapy product developed by NeuExcell Therapeutics, was successfully completed at the Fourth Affiliated Hospital of Soochow University (Suzhou Dushu Lake Hospital). The procedure was carried out by...
Epigenetic Editing Explodes on the Heels of Gene Editing Success
Coinciding with the historic approval of Vertex and CRISPR Therapeutics’ Casgevy as the first CRISPR-based therapeutic, epigenetic editing, which targets parts of the genetic code beyond the DNA itself, is having a moment. One company is already in the clinic, and two...
AbbVie Acquires Landos in Potential $212M Deal, Bolsters Anti-Inflammatory Pipeline
As its blockbuster Humira is facing pressure from biosimilars, AbbVie is leaning on dealmaking to expand its portfolio. The Chicago-based pharma announced Monday it is acquiring Landos Biopharma in a deal worth up to $212 million. The buy lands AbbVie with Landos’...
First gene therapy for children with metachromatic leukodystrophy approved by FDA
The U.S. Food and Drug Administration has approved Orchard Therapeutics' Lenmeldy (atidarsagene autotemcel) as the first gene therapy for the treatment of children with metachromatic leukodystrophy (MLD). Lenmeldy is a one-time, individualized single-dose infusion...
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