Analytical 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

Bioconjugation

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.

Test

Methods for DS release testing

Methods for stability testing

Appearance (Color/Clarity), pH

Protein Concentration - SoloVPE

Peptide Mapping

Residual HCP

Raw Material Testing

Isoelectric Focusing (iCIEF)

Size Homogeneity (SEC)

Residual DNA

Residual Protein A

CE-SDS (Reduced / Non-Reduced)

Cell-Based, Bioassay or ELISA Potency/Binding

Glycan Analysis

Osmolality

Bioburden / Endotoxin

Polysorbate80

Polysorbate 80

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	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
LC-MS	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
ELISA	Binding Assay, Bridging Assay	12-16	8
Cell-Based Assay	Potency/Cytotoxicity	24	20
GC	Residual Solvents	8-12	4