Analytical Development

Services

분석법 개발

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

원부자재 및 Buffer 유래 원소 불순물 분석 – ICP/MS
Colloid 및 Aggregate 분석 – DLS
가시이하 미립자 분석 – Flow Imaging

PPQ / Manufacturing Process Comparability

후기 임상 단계 고객을 위한 맞춤형 통합 비교동등성 평가 패키지
제조 스케일업 및 공정 변경 전후 비교동등성 평가 전 과정 지원
상업 생산 공정 밸리데이션을 위한 CQA 평가

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

롯데바이오로직스는 검증된 분석법 템플릿을 바탕으로 분석법 개발 및 검증의 효율성을 높여 개발 기간을 단축하고, 고객의 상업 생산 일정을 가속화합니다.

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

롯데바이오로직스는 검증된 Template Analytical Method를 활용하여 분석법 개발에 소요되는 시간을 단축하고, 고객의 제조 일정을 가속화합니다.

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