Analytical Development
롯데바이오로직스는 바이오의약품 개발 전 과정에 필요한 분석법 개발 서비스를 제공합니다. 개발 단계에 맞춘 데이터 기반 접근을 통해 제품 이해와 공정개발을 지원하고, 규제 대응에 필요한 분석 기반을 구축합니다. 단일클론항체(mAb)부터 첨단 모달리티까지 폭넓게 지원합니다.
Advanced Characterization Capabilities
Commercial Manufacturing Forensic Analysis
- Elemental impurity analysis from bag and buffer leachables /extractables - ICP/MS
- Colloid and aggregate analysis - DLS
- Subvisible particulate analysis - Flow imaging
PPQ / Manufacturing Process Comparability
- Turn-key comparability evaluation package customized for late-phase clients
- Turn-key support for comparability assessment before and after manufacturing scale-up and process changes
- Commercial process validation CQA evaluation
Expansion into Various Modalities -
Biopharmaceutical Characterization
Antibody
Fusion Protein
Bispecific Antibody
Bioconjugate
Molecular Comparability Assessment
- Biosimilar analytical similarity
- Process change comparability
- PPQ comparability pkg
- Critical PTM characterization
- Site-specific glycosylation analysis
Particle Risk Assessment
- Aggregation root cause investigation
- Process-induced particle characterization
- Particle morphology assessment
- Container closure interaction studies
Functional Analysis
- Target binding characterization
- Binding kinetics assessment (SPR)
- Effector function characterization
- Potency assay dev & qualification
- Structure-function relationship assessment
Advanced Molecular Characterization
- Host cell protein profiling
- Multi-attribute monitoring (MAM)
- Intact protein characterization
- Glycopeptide analysis
- Native mass spectrometry
- Sequence variant identification
Analytical Testing
롯데바이오로직스는 검증된 분석법 템플릿을 바탕으로 분석법 개발 및 검증의 효율성을 높여 개발 기간을 단축하고, 고객의 상업 생산 일정을 가속화합니다.
롯데바이오로직스는 검증된 Template Analytical Method를 활용하여 분석법 개발에 소요되는 시간을 단축하고, 고객의 제조 일정을 가속화합니다.
| Method | Attribute | Protein | AXC | Typical Development Time (Weeks) | Development Time w/Templates (Weeks) |
|---|---|---|---|---|---|
| SEC-HPLC/UPLC | Aggregation, Size impurities | 12 | 4 | ||
| RP-HPLC | Titer, Subunit Analysis | 12-16 | 4 | ||
| LC-MS | MW (Subunit/Intact Mass), Glycans, Drug Load Distribution | 12-16 | 4-8 | ||
| Peptide mapping, Native SEC | 20-24 | 12-16 | |||
| CE-SDS (R/NR) | Fragments, Purity | 12-16 | 4 | ||
| iCIEF, CZE | Charge Variants | 12-16 | 4 | ||
| HPLC/UPLC | Charge Variants, Glycan Profiling, Dimer (bispecific), DAR, Surfactants, Sialic Acid | 12-16 | 4 | ||
| A280/SoloVPE | Protein Concentration | 6 | 3 | ||
| qPCR | rDNA | 12-16 | 4 | ||
| FDRi | Free Drug Related Impurities | 12-16 | 6 | ||
| ELISA | rProtein A, rHCP | 8 | 4 | ||
| Binding Assay, Bridging Assay | 12-16 | 8 | |||
| Cell-Based Assay | Potency/Cytotoxicity | 24 | 20 | ||
| GC | Residual Solvents | 8-12 | 4 |
Why Partner with Us?
Robust Analytical
Method Development
Method Development
Advanced Characterization &
Comparability
Comparability
Phase-Appropriate
Lifecycle Support
Lifecycle Support