CDMO

Successful Cell and Gene Therapy Journey
from Concept to Cure

At GC Cell, we're more than just a CDMO; we're pioneers with our own commercialized cell therapy product.
We understand the unique challenges of cell and gene therapy, inside and out, who knows what you need and when you need it.
Our comprehensive, end-to-end capabilities mean we've faced every potential issue - and we know exactly how to overcome them.
With us, your vision is in experienced hands, ensuring a seamless journey from groundbreaking research to life-changing cures. Trust in our expertise for added value at every step, paving the way for your therapy's success.

We're pioneers

with our own commercialized cell therapy product

72,400+

Commercial Batches

10,000+

Personalized Cell Therapy

Fully-Integrated Cell and Gene Therapy CDMO

360 ° Approach
to Cell and Gene Therapy

With more than 17 years of cell therapy research and commercialization, we have fully-integrated capability and capacity to support our clients throughout the entire journey.
Tech Transfer
Harmonized Cross border

Flexibility for seamless intercontinental tech transfer between Asia and USA. Flexibly switch manufacturing to where the product is needed the most.
Bio Logistics
Cold Chain Supply

From vein to vein, GC Cell is the only All-in-One provider that can collect sample, manufacture and deliver final product back to the patient.
Commercial Expertise
with Forward Thinking

The concept of 'end in mind' is particularly crucial for cell therapy modality. GC Cell is not just focused on the development and manufac-turing aspects of cell therapy but is also acutely aware of the market dynamics and regulatory require-ments that will come into play once the product reaches the market.

Our dedicated Project Managers drives customer success

01 Transparent project planning &
status sharing with client (GANTT Chart)
02 Quick to escalation for decision-needing solutions
03 No hidden costs beyond the agreed scope of work

Learn more how our project managers drive your success

Contact Us

End-to-End Cell and Gene Therapy with 5-EX Commitment

EXPEDITE

One-stop-shop service with in-house analytics
Fast & streamlined tech transfer

EXPERIENCE

More than 70,000 commercial batches
manufactured to date
Treated > 10,000 patients with personalized
cell therapy

EXPERTISE

Expertise in scale-up diverse modalities
including NK / T / Stem cells
Conforming to global quality standards

FLEXIBILITY

Flexible contingency management by multi-suite
slot management system

EXACT

On-time delivery
Led by dedicated project managers

Manufacturing Site

Harmonized CDMO services to facilitate seamless cross-border technology transfers to improve access to life changing, high quality cell therapies.

APAC
US

APAC
Site Overview
- 20,806m² 4 stories high with 2 basement levels
Capacity
- 14 Clean rooms
- 18,000 pack/year (based on immuncell-LC)
Capability
- Process and analytical development
- Clinical and commercial manufacturing
US
Site Overview
- BioCentriq Life Science Engineering center (3,200ft²)
- BioCentriq 7 Deerpark Dr. (5,800ft²)
Capacity
- 4 Clean rooms
Capability
- Clinical manufacturing
- Process and analytical development

Our Service

Pioneering cell and gene advancements, unparalleled expertise in advancing cell and gene therapy research and driving commercialization success for a seamless, end-to-end customer-centric service.

CMO
CDO
CAS

CMO Service

Advanced Biological Product CMO (Cell Therapy/Gene Therapy)

Cell Bank(MCB/WCB) Manufacturing
Commercial Product Manufacturing
Investigational Product Manufacturing
Aseptic Process Validation

CDMO Procedure

STEP 01
Client Contact
STEP 02
Sign Non-dislosure
Contract
STEP 03
Technical Exchange
Project Scope Discussion
STEP 04
Proposal
(Quotation)

STEP 07
GMP Engineering Run
GMP Product Manufacturing
STEP 06
Tech Transfer &
Scale-up
STEP 05
Contract Negotiation
& Execution

CDO Service


Process Development Service	a. Establishing large-scale culture methods according to GMP standard b. Specification of the cell culture and manufacturing methods
Quality Test Development Service	a. Establishing test standards for incoming raw materials b. Setting up donor tissue suitability test and IPC criteria standardization c. Quality control criteria establishment d. Procure stable packaging and long-term storage system
RA Consulting	a. CTD Module 3 documentation filing b. Consultations on IND approval