TY - M-10486
AU - Raghunathan, Niranjana
TI - A Cross-Domain Enterprise LIMS Architecture for Organ Bioprinting: Bridging R&D, Process Development, QC, and GMP Manufacturing
T2 - Scientific Research Journal of  Biology and Life Science

PY - 2026
VL - 4
IS - 1
SN - 2584-0606

AB - Organ-scale
three-dimensional (3D) bioprinting is poised to transform transplantation
medicine and advanced therapeutics; however, translation from laboratory
innovation to regulated, multi-site manufacturing remains constrained by
fragmentation across research (R&D), process development (PD), quality
control (QC), and GMP production. This paper presents a cross-domain enterprise
systems architecture that positions Laboratory Information Management Systems
(LIMS) as the digital backbone spanning discovery through commercial
manufacturing, establishing a continuous, auditable digital thread for organ
bioprinting. We define quantitative manufacturing and translation metrics
Reproducibility Index (RI), Throughput Scalability Factor (TSF), Protocol
Deviation Rate (PDR), and Documentation Completeness Score (DCS) and a
validation-by-design lifecycle aligned to GAMP5. The framework is grounded in
thirteen years of enterprise-scale LIMS and data-integrity leadership across
pharmaceutical R&D, QC, and manufacturing. This paper follows the SCIRP
structure and proposes a systems engineering framework integrating LIMS into
bioprinting. We argue that organ bioprinting will not become an industrial
discipline without cross-domain informatics governance, and we provide an
immediately actionable blueprint for implementation.

KW - Organ Bioprinting
KW -  Enterprise LIMS
KW -  Digital Thread
KW -  R&D
KW -  Process Development
KW -  QC
KW -  GMP
KW -  Systems Architecture
KW -  GxP
DO -