Medical Consumables and Lab Consumables OEM Manufacturer
Medical Consumables and Lab Consumables OEM Manufacturer
CDMO Services

Trusted Cell Therapy CDMO

Advancing Cellular Therapy Quality Control

Hillgene provides full-service CDMO solutions for CAR-T, CAR-NK, and TCR-T therapies, supporting your journey from research to GMP manufacturing and beyond. As a specialized cell therapy CDMO, we offer expertise in CAR-T manufacturing, viral vector production, and regulatory support. Our agile team helps biotechs accelerate development with flexible, scalable, and compliant processes. Whether you're entering clinical trials or preparing for commercialization, our customized approach ensures speed, quality, and reliability at every stage. Partner with us to bring your next-generation therapies to life, faster and smarter.


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Our Customers


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Cell Therapy Innovation Inspired

Your Reliable Partner in Cellular Therapy

Jiangsu Hillgene, headquartered in Suzhou with a 10,000㎡ GMP facility and R&D center, operates manufacturing sites in Shenzhen, Shanghai, Belgium, and the USA to strengthen its global presence. Hillgene has established specialized platforms for nucleic acid production, serum-free suspension culturing, closed-process development, ELISA kit and ELISA test-based QC testing for cellular therapies. These platforms have successfully supported the development of multiple CAR-T, TCR-T, and stem cell-based products. Hillgene is dedicated to accelerating cellular therapy advancements, bringing innovative treatments to patients faster.


Hillgene also provides comprehensive regulatory support, customized process development, and flexible manufacturing scales to suit projects from preclinical to commercial stages. Our expert team collaborates closely with clients to optimize timelines, reduce risks, and ensure compliance with global standards, making us a trusted CDMO partner in the cell and gene therapy space.

17+

Successful IND Submissions 

200+

Prepared Cells for

Clinical Use

18000+

GMP Facility (m2)

20+

Partnered GCP Sites

Hillgene's Recommendation

Hillgene's BlueKit detection kits detect biological residues and functions during cellular drug production, ensuring quality control in CAR-T and other therapies.
BlueKit for Plasmid

Comprehensive ELISA/qPCR kits for residual host cell DNA, RNA, and proteins (e.g., HCP, BSA) in plasmid-based products. Validated for sensitivity and compliance with biopharmaceutical quality standards.

BlueKit for Lentivirus

Analytical solutions for lentivirus safety and quality: p24 ELISA, residual DNA/RNA detection, and HCP quantification. Supports GMP-compliant viral vector production and regulatory submissions.

BlueKit for Cell

Multiplex ELISA kits for CRS cytokines (IL-2, IL-6, IFN-γ) and residual cytokine quantification. Essential for immunotoxicity assessment and cell therapy safety profiling.

BlueKit for mRNA

Residual enzyme detection (DNase I, T7 RNA polymerase) and dsRNA quantification kits. Validates mRNA purity and process compliance in vaccine/therapeutic production.

BlueKit for Antibodies/Vaccines

Host cell protein (CHO, Sf9) and DNA detection kits for biologics. Ensures compliance with purity standards in antibody/vaccine manufacturing.

Internally Researched Products

Designed to support gene therapy workflows, they ensure product safety and help meet stringent regulatory requirements through sensitive, accurate quantification.

Hillgene's Updates
Oct 20 2025
What CDMO Means in Pharmaceutical Manufacturing
Oct 20 2025
The pharmaceutical industry is a complex ecosystem that involves various players and processes aimed at delivering safe and effective treatments to patients worldwide. One of these key players is the ...
Oct 10 2025
Benefits and Risks of Stem Cell Products
Oct 10 2025
The rapid advancement in biomedical research has propelled cell therapy products into the limelight as a novel solution for a variety of medical conditions. These innovative interventions have shown p...
Sep 30 2025
How Cellular Therapy Works at a Molecular Level
Sep 30 2025
Cell therapy products are revolutionizing the medical sector by offering innovative treatments for a variety of diseases and conditions. At its core, cellular therapy leverages the body's own cell...
Jan 20 2026
Asia-Pacific Gene Therapy Market Poised to Reach US$14.59 Billion by 2033, Report Says
Jan 20 2026
January 2026 — Industry NewsThe Asia-Pacific gene therapy market is projected to experience rapid growth over the next decade, with market size expected to reach approximately US$14.59 billion by 20...
Jan 18 2026
FDA Declines Approval of Atara’s Cell Therapy for Rare Blood Cancer
Jan 18 2026
January 13, 2026The U.S. Food and Drug Administration (FDA) has declined to approve Atara Biotherapeutics’ cell therapy tabelecleucel for the treatment of Epstein-Barr virus positive post-transplant ...
Jan 16 2026
FDA Expands Regulatory Flexibility for Cell and Gene Therapy Development
Jan 16 2026
January 2026The U.S. Food and Drug Administration (FDA) has announced an updated regulatory approach aimed at increasing flexibility in the development and manufacturing oversight of cell and gene the...
Dec 01 2022
NMPA issued the Announcement on “Implementing Electronic Application of Drug Registration”
Dec 01 2022
In order to improve the efficiency of drug review and approval, the National Medical Products Administration has decided to implement electronic submission of drug registration application materials. ...
Nov 30 2022
MAH issued“Provisions for Supervision and Administration of Drug Quality (Interim)”
Nov 30 2022
On November 29, the State Food and Drug Administration publicly solicited opinions on the "Regulations on the Supervision and Management of Drug Quality by Drug Marketing Authorization Holders&qu...
Nov 03 2022
Big News: Newly released “Good Manufacturing Practice for Cellular Therapy Products (Interim)”!
Nov 03 2022
On October 31, 2022, in order to guide the drug MAH to standardize the production and quality management of cell therapy products, the National Bureau Verification Center issued the "Guidelines f...