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Our experience even extends more than just providing the production services.
Services
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Cell Productions

Preclinical Grade GMP Grade

 

Preclinical Grade

With our closed and automated system, Forecyte Bio offers high efficiency transduction process of genes to cells. Our experience enables us to handle several different kinds of cells such as CAR-T, TCR-T, CAR-NK.

 

Preclinical Grade

 

GMP Grade

With our GMP facility in place, Forecyte is ready to provide production service under GMP conditions that meet the stringent requirements by different regulatory bodies such as FDA, NMPA, and EMA. Production scale supports clinical trials and commercial launch.

 

QC

Our quality is supported by our strict QA/QC policies and analytics; it includes

 

Category

Attribute

CAR-T

General Cell

Strength/Potency

Cell concentration

Cell viability

Cytokine ELISA Titer

CAR+% (Flow)

 

Identity

Flow cytometry (cell CD marker typing)

Purity

Flow cytometry (cell CD marker typing %)

Residual beads

Residual vector (VSV-G)

Safety

Endotoxin

Sterility (BACT/ALERT 3D)

RCL (PCR) 

Mycoplasma (PCR)

Residual tumor cell (Flow)

General property

Product appearance/color

pH

Osmolality

Contact

Forecyte Bio Limited

US:

21 Byte Court, Frederick MD 21702
Tel.: +1 215-589-3593

China:

Second floor, building 6, No. 88, Maji Road, China (Shanghai) pilot Free Trade Zone
Tel.:+ 86 13052599328
E-mail:info@forecytebio.com

+1 215-589-3593
info@forecytebio.com
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