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Our experience even extends more than just providing the production services.
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Viral Vector Productions

Preclinical Grade GMP Grade

 

Preclinical Grade

Using our own serum-free suspension 293 mammalian cell lines, using our own helper plasmid design, we can transfect the plasmids at high levels reaching 1x1014 vg/L for Adeno-Associated Virus (AAV) and 1x1011 TU/L for Lenti Virus (LV).

Our unique separation and purification process can effectively reduce the aggregation state typically facing viral vectors, and greatly improve the activity and purity levels. In the case of AAV, the Full/Empty ratio can be dramatically increased as well to have the fully-loaded virus reaching close to 100%

Forecyte Bio builds its program to reflect the customer’s need, it generally covers tech transfer, Process Development, and engineering runs.

 

Viral Vector

 

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

AAV

LV

Strength

Viral genome titer (qPCR)

FACS Titer

 

ELISA Titer (p24)

 

Total protein content

Identity

Gene of interest expression

Restriction enzyme mapping

Potency

Target protein expression (FACS)

 

Target protein activity (cell based)

 

Purity

Residual 293T HCP

Residual 293T HCD

Residual BSA

 

Residual nuclease

Residual plasmid

Residue PEI

 

Full/empty ratio (AUC)

 

Capsid protein purity

 

Packaged plasmid

 

 

E1A copy number

 

 

SV40 copy number

 

Safety

Sterility

Mycoplasma 

Endotoxin 

RCL (culture based)

 

Adventitious virus

rcAAV

 

General property

pH 

Product appearance

Particulate

Color

Fill volume

 

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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