>>987 นี่มึงต้องให้กูแหกให้หมดเลยใช่ป่ะ
The AS manufacturing and testing facilities are described, and the manufacturing sites of the active substance are provided in Table 1.
หลังจากนี้คือขั้นตอนผลิตactive substance
The cell culture consists of four steps: vial thaw, inoculum expansion in shake flasks and rocker bags, seeding of bioreactor(s) for further expansion of inoculum and production bioreactor to generate crude AZD1222. For the description of the manufacturing process, the process parameters (critical process parameters (CPPs) and non-critical process parameters NCPPs), process outputs (in-process controls (IPCs), microbial controls (MCs) and performance attributes (PAs) are considered satisfactory.
เชื้อต้นแบบจะเอาไปinoculateในจานเพาะเซลล์ เข้ากระบวนการเพิ่มจำนวนเซลล์
The production bioreactor cell culture is lysed using detergent-based cell lysis, treated with nuclease for reduction of host cell DNA and then clarified via depth filtration. The clarified lysate is further processed through a membrane chromatography step designed to remove process-related impurities. This is followed by concentration and diafiltration using tangential flow ultrafiltration to remove process-related impurities and for buffer exchange. Next, a formulation step and a 0.2 μm filtration step into specified containers follows to generate the AS. The AS is frozen for storage (at -90°C to -55°C) and shipping.
เอาเซลล์ที่เพาะได้ไปทำให้บริสุทธิ์เหลือแต่ไวรัส แล้วแช่แข็ง
โรงงานที่ผลิตขั้นตอนนี้มีตามที่กูโพสต์ไว้ (ไม่มีSBS)
The frozen AS is shipped at -90 to -55°C to the FP fill facility. Upon receipt, the AS is stored at -90 to -55°C prior to processing. The AS is thawed, mixed and pooled into a mixing vessel and dilution buffer is then added to the mixing vessel. Dilution buffer and AS is then mixed to produce final bulk. The final bulk is 0.45 μm (bioburden reduction) filtered into a holding bag prior to filling. During the filling process, the final bulk is 0.2 μm sterile filtered, using redundant sterile filters in series, as it is aseptically filled into sterile vials, closed with sterile stoppers, and sealed with aluminium caps. The resulting FP is 100% visually inspected, packaged and labelled on site.
ขนส่งactive substanceที่ถูกแช่แข็งไปยังโรงงานบรรจุ ละลาย dilute ผสมสารต่างๆเพิ่มเติม
เอาล่ะ ตกลงSBSผลิตขั้นตอนไหนบ้าง ขอหลักฐานด้วย
