LOTTE Biologics Implements ValGenesis e-Logbook Solution to Modernize QC Operations

SANTA CLARA, Calif.--(BUSINESS WIRE)--ValGenesis, Inc., the global leader in enterprise digital validation and compliance solutions, today announced that LOTTE Biologics, a rapidly growing contract development and manufacturing organization (CDMO) headquartered in Seoul, South Korea, has successfully gone live with the ValGenesis e-Logbook solution. The digital logbook management tool transforms operational execution in regulated environments with complete traceability and control.

Founded in 2022, LOTTE Biologics entered the pharmaceutical industry with the ambition of becoming a leading global CDMO. The company operates a Bio Campus in Syracuse, New York, and is nearing completion on the construction of a state-of-the-art Bio Campus in Songdo, South Korea, where it is operating a satellite quality control (QC) lab as a precursor to the main facility.

As part of its digital transformation journey, LOTTE Biologics has implemented ValGenesis in its satellite QC lab, with plans to extend the platform across its main laboratory and production facilities in the upcoming Songdo Bio Campus. The go-live represents a major milestone in building a fully digital and connected quality ecosystem across the organization.

LOTTE Biologics intends to solidify their digital foundation through the implementation and enhancement of enterprise systems, including LIMS, EAM, and EDMS, to support seamless data flow, strengthen consistency, and improve overall operational efficiency. The company is also exploring instrument data automation via the ValGenesis Gateway, which enables direct data capture from laboratory instruments, reducing manual effort, improving accuracy, and providing real-time insights for faster decision-making. The solution replaces paper-based logbooks with real-time digital forms accessible across devices. It supports QR and barcode-based form selection, offline data capture, and no-code configuration to align with standard operating procedures (SOPs). The ValGenesis e-Logbook system ensures regulatory compliance through role-based access, timestamped audit trails, and automated review workflows, and it delivers enterprise-wide visibility when integrated with MES, QMS, LIMS, and CMMS systems.

“This project represents more than just a system implementation—it marks a meaningful transformation for LOTTE Biologics,” said Hyunjin Cho, IT Team, LOTTE Biologics. “By replacing paper-heavy QC processes with streamlined digital workflows, we have built a more efficient, reliable, and scalable environment that enhances quality management and prepares us for future growth.”

“We are proud to partner with LOTTE Biologics on this journey toward digital excellence,” said Terrance Blackwell, Chief Delivery Officer at ValGenesis, Inc. “The successful go-live underscores our shared commitment to innovation, data integrity, and operational efficiency. With this milestone, LOTTE Biologics takes an important step toward building a fully digital, automated, and compliant R&D-to-manufacturing ecosystem—supporting its vision to become a global leader in biopharmaceutical development and manufacturing.”

About LOTTE Biologics

LOTTE Biologics is a contract development & manufacturing organization (CMDO) delivering integrated biologics and bioconjugate services across the full product lifecycle. Their capabilities encompass phase-appropriate DS manufacturing for mammalian-cell-based biologics, including monoclonal antibodies, fusion proteins, multi-specifics, and integrated ADC manufacturing.

Guided by the vision "Possibilities Beyond Limits," LOTTE Biologics works alongside innovators of all sizes to enable efficient scale-up, dependable execution, and the advancement of transformative therapeutic programs. For more information visit: https://www.lottebiologics.com/en

About ValGenesis Inc.

ValGenesis, Inc., is the global leader in enterprise digital validation. Serving the life sciences industry for nearly two decades, ValGenesis enables companies to digitize their commissioning, qualification, and validation processes through its AI-enabled ValGenesis Smart GxP™ platform, which includes solutions for risk management, cleaning validation, continued process verification, and CMC development. ValGenesis helps customers worldwide reduce costs, improve compliance, and accelerate innovation. For more information visit: https://www.valgenesis.com/