Quality, Research & Product Development
Rigorously characterizing strains, optimizing biomanufacturing yields, and generating analytical regulatory documentation to support commercial formulations.
Research & Development Workflow
Systematic stages governing every product developed at SPACEGEN LIFECARE.
Strain Screening
Molecular identification, antibiotic resistance profiling & CFU stability.
Formulation Development
Excipient compatibility, DRcaps selection & moisture barrier testing.
Process Optimization
Carbon/nitrogen feed rates, dissolved oxygen & temperature kinetics.
Stability Evaluation
Accelerated and real-time ICH Q1A thermal storage protocols.
Application Development
Beverage matrix, feed pelleting & tablet compression trials.
Scale-Up Studies
Bioreactor scale-up from 10L pilot units to commercial bioprocess tanks.
Quality Documentation Dossiers
Every batch dispatched from our facilities is accompanied by standardized analytical technical dossiers.
Batch-wise assay, CFU count, and purity parameters.
Physical, chemical, and microbiological specifications.
Common Technical Document module support.
Drug Master File reference technical information.
Complete process execution trace.
Stability Evaluation Protocols
Conducted in accordance with ICH Q1A guidelines to determine strain potency and shelf-life decay curves.
Accelerated Stability Testing
6-month accelerated storage protocol assessing heat and moisture resilience under stressful environmental conditions.
Real-Time Stability Testing
24 to 36-month ambient real-time monitoring ensuring label claim potency throughout the assigned shelf life.
Request Analytical & Stability Data
Contact our quality assurance department for technical datasheets and sample CoAs.