Custom GMP Grade Peptides를 소개하는 brochure로 Research Grade와 GMP Grade 비교표를 통해 제품 정보를 확인하실 수 있습니다.
Applications
In vitro
DIAGNOSTICS
BIOPHARMACEUTICAL
PRECURSOR
& material manufacturing
PRE-CLINICAL
animal testing
QC CONTROLS & STANDARDS
for biopharmaceuticals & API’s
Peptide Grades Comparison
| SMALL & LARGE SCALES | ||
| CLASSICAL & COMPLEX Peptide chemistry (cyclic, stapled, phosphorylated, biotinylated, fluorescent dye or quencher labeled or both for FRET/TR-FRET) |
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| Attributes | Research Grade | GMP* Grade |
| Product Applications | Research & Discovery | IVD BioPharma Processing QC Standards |
| Quality Systems Controls | ISO 9001 | ISO9001 Compliant with 21 CFR part 820 & ISO13485 |
| Service Agreement / Audits | Standard | |
| Analytical Methods | v | v |
| Certificate of Analysis | v | v |
| Change Control Notification | v | v |
| Product Specification | v | v |
| Incoming Raw Material Specification & Testing | v | |
| Expiry or Retest Date | v | v |
| Supplier Qualification | v | |
| Identification of Critical Process Parameters | v | |
| Batch Manufacturing Record & Review | v | |
| Lot Sample Retained | v | |
| Dedicated Project Management | v | |
| Classified clean room ISO7 (10.000) | v | |
| Validation | ||
