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

Preclinical Grade GMP Grade

 

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 animal component free process is designed to meet the requirements of global regulatory bodies, scaled to 300L in volume and achieve the productivity of gram per liter. Our downstream chromatography purification allows us to produce high quality plasmid DNA with high level of supercoiled DNA, low endotoxin, and low residuals (host RNA, DNA, protein). Single-use fermenter and purification apparatus also warrants no cross-contamination in both the up-stream and down-stream processes.

 

Plasmid

 

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

Contact

Forecyte Bio Limited

US:

7495 New Horizon Way, Suite 130-150, Frederick MD 21703
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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