From its inception in 2005, our peptide synthesis facility was designed to comply with cGMP regulations. Since operation began in 2006, it has been inspected by several of our customers from the US and Europe.
At GenScript, the manufacturing of cGMP-grade peptides is conducted in a dedicated, limited access suite. Temperature, humidity, and air pressure are strictly controlled. Our air supply system is outfitted with terminal filters. All walls, floors, and ceilings are finished with highly durable, easily cleaned materials. We have separate designated areas for raw materials storage, sampling and testing.Final peptide product is lyophilized in cleanrooms with their own air supply system and packaged in a dedicated packaging operations
room (grade A area). Our QA/QC department develops and maintains SOPs for facilities cleaning and maintenance. We have a dedicated microbiology lab to support the environmental testing.
The facility is equipped with two SPPS synthesizers, each with a 20 L capacity. We are also prepared to perform LPPS if required. Our manufacturing suite is outfitted with other preparative and analytical equipment including HPLC, LC-MS, and GC. The peptide isolation process is carried out using two lyophilization systems, each with capacity of 8 L. All equipment used in the manufacturing process is validated by our scientists. We develop and update SOPs for equipment maintenance and equipment maintenance logs.
