Analytical Development
- Services
- Antibody Development Services
- Analytical Development
LOTTE Biologics provides analytical development services to support biologics programs throughout development. Through a phase-appropriate, data-driven approach, we help generate the analytical knowledge needed to support product understanding, process development, and regulatory readiness across traditional mAbs and advanced modalities.
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
At LOTTE Biologics, we offer our clients the ability to leverage our template analytical methods to save time and accelerate their manufacturing timelines.
At LOTTE Biologics, we offer our clients the ability to leverage our template analytical methods to save time and accelerate their manufacturing timelines.
| 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?
Method Development
Comparability
Lifecycle Support