R & D Lab & Manufacturing Plant
- Specialized R&D Labs: Molecular biology, Biosafety, Fermentation, Protein purification, Formulation development, Microbiology, Biochemistry, Cell-based bioassays, Chemistry, Plasma fractionation.
- Commercial Manufacturing: Seed development, fermentation, Protein purification, Sterile injectable formulations, Warehouse setup, and Quality control laboratories.
Cell Line Development & Validation
- Recombinant cell line development
- GMP-compliant Cell Bank manufacturing
- Cell Bank characterization and biosafety assessment
Analytical Methods
- Development & validation of analytical methods
- Continuous method performance verification
- Life cycle management of analytical methods
- Critical quality attributes and process parameters
- Expertise in Chemical, Biochemical, Microbiological, and Cell-based bioassays
Electronic Document Management & Process Digitalization
- Implementation of digital tools for R&D and manufacturing plants
- Process flow mapping, data trending, dashboard creation
- SOPs, protocols, and report management
- Integration of instruments, automation of material and quality control
- Digital tracking of batch manufacturing and information systems
Bioprocess Controls
- Identification of CPPs and CQAs, Viral validation studies
- Process capability and control charting
- Cleaning validation in biopharmaceutical processes
- Process validation, technology transfer & continuous performance verification
- Compliance with PDA, FDA, EU, and ICH standards
Bioprocess Equipment Qualification
- User Requirements Specification (URS), DQ, IQ, OQ, PQ lifecycle
- Risk assessment and system boundary identification Characterization of Drug Substance and Product
Structural and functional characterization
- Risk assessments, impurity profiling, stability studies
- Preparation of protocols and technical reports
