Quality

Quality is embedded across every stage of manufacturing at LOTTE Biologics, supported by robust systems, experienced teams, and a proactive approach to quality management.

Quality delivered across Two Continents, under One Quality Standard, with Zero Compromise.

Harmonized quality practices, integrated digital systems, and ongoing GMP training help drive consistent execution and proactive quality management across both sites.

eQMS

Electronic Quality Management System

Provides complete traceability of approvals, changes, and user actions to support compliance

LIMS

Laboratory Information Management System

Ensures analytical data traceability, trending, and lifecycle management

EAM

Enterprise Asset Management

Supports equipment reliability, maintenance management, and operational readiness

DeltaV

Facility Management

Enables real-time monitoring and recording of process conditions and results to ensure data integrity and manufacturing reliability

Quality Control

LOTTE Biologics provides integrated quality control from raw material testing through drug substance release, supporting consistent product quality, efficient release, and reliable manufacturing operations

In Process Testing

24/7 staffed lab for critical assays (SA, Titer, Product Concentration)
Provide expedited turnaround on assays required for changeover (TOC)

Raw Material Release

Full capability to test incoming RMs to support manufacturing
Strategically partnered with 3rd party lab to provide excess capacity and backup capability

Drug Substance Release

Perform necessary cell-based and separations-based testing to support release (Bioassay, PCR, HPLC, Glycan structure, peptide map, CE-SDS, etc.)

QC Logistics

Sample management, contract vendor management
Method performance monitoring

Quality Control Microbiology

LOTTE Biologics maintains comprehensive microbiological testing and monitoring programs to support reliable aseptic manufacturing and consistent product quality

Microbiological Assays

Extensive Bioburden and Endotoxin sampling and testing
Provide 7-day testing coverage
In house ability for ID, MMV, and Mycoplasma testing, environmental trending
Contamination investigations

Facility Strategy

Cleanroom contamination control strategy
Aseptic process support
Facility walkthrough and risk assessment program

Environmental Monitoring

Dedicated environmental monitoring program
Rapid cleanroom recovery support
Support for aseptic qualification activities

Related Services

CMC & Regulatory Support

Analytical Support

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