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
Preclinical Grade
Research plasmids take all shapes and sizes, and they are not created equal in terms scalability. Forecyte Bio helps clients to focus on the design and delivery of the plasmids that will meet the criteria for scale-up down the road for clinical and commercial purposes.
Forecyte Bio works closely with its clients to conduct the process development work and deliver a scalable process that will be further demonstrated by engineering runs.
Our solvent-free animal-component-free process is designed to meet the requirements by regulators, and can be scaled to 300L fermentation volume at g/L titer yield. Our downstream purification using state-of-the-art column chromatography to ensure the quality meeting the high standard with > 90% super spiral purity, low endotoxin level, and low residue level (RNA, DNA, protein). Single-use fermenter and purification apparatus also warrant no cross-contamination in both the up-stream and down-stream processes.
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 |
Identity |
DNA sequencing |
Restriction enzyme sites verification |
|
DNA Gel electrophoresis |
|
Purity |
Supercoiled content level (HPLC) |
Plasmid purity (Gel electrophoresis) |
|
A260/A280 value |
|
Residual Host E.Coli protein |
|
Residual Host E.Coli DNA |
|
Residual RNA content |
|
Safety/Strength |
Product Appearance |
pH |
|
Plasmid Concentration |
|
Mycoplasma |
|
Endotoxin |
|
Sterility |
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
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