Preclinical Grade 플라스미드
- 엔도톡신 free 플라스미드, 동물 유래 성분 배제 공정 선택 가능
- Mouse부터 NHP까지 다양한 in vivo 연구에 적합
- 10mg부터 최대 100g까지 확장 가능한 생산 규모 제공
장점
-
슈퍼코일 함량 및 엔도톡신 수준에 대한 종합적인 품질 관리
-
정량적 불순물 분석
-
동물 유래 성분 없는 생산 옵션 제공
-
10mg부터 100g까지 보장된 생산량 및 소재 보관 옵션 제공
상세내용
Production details
| PackGene plasmid process | Preclinical |
|---|---|
| Clone screening | √ |
| Growth condition optimization | √ |
| High density fermentation | √ |
| Alkaline lysis | √ |
| Chromatographic purification | √ |
| Antibiotics free | √ |
| Consistent manufacturing process | √ |
| Instrument calibration/validation | Calibration |
| COA & CoC | COA |
| TSE/BSE | O |
| Antibiotics Free Production | √ |
| Animal Free Production* | O |
| Material Archiving | Plasmid archived, additional charges for bacteria |
Quality Control
| Test | Methods |
|---|---|
| Appearance | Visual inspection |
| A260:280 | Ultraviolet-visible spectrophotometry (A260/A280) |
| Homogeneity | HPLC |
| Restriction Analysis | Agarose gel |
| Residual RNA | SYBRGold |
| Residual E. coli DNA | qPCR |
| Endotoxin | LAL |
| Bioburden Testing | Direct inoculation |
| Sequencing | Sanger |
| Residual Host Protein | HCP ELISA |
| Mycoplasma Contamination | qPCR |
| pH | Potentiometry |
| Residual Kanamycin | ELISA |
| Sterility | |
| Osmolality |
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