Forecyte Bio Limited
US:
7495 New Horizon Way, Suite 130-150, Frederick,MD 21703
Tel.: +1 215-589-3593
China:
177 Yiwei Road, Pilot free trade zone, Shanghai, China
Tel.:+86 21 80438700
E-mail:info@forecytebio.com
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.
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 |
● |
● |
Forecyte Bio Limited
US:
7495 New Horizon Way, Suite 130-150, Frederick,MD 21703
Tel.: +1 215-589-3593
China:
177 Yiwei Road, Pilot free trade zone, Shanghai, China
Tel.:+86 21 80438700
E-mail:info@forecytebio.com
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