Neuland’s upcoming commercial peptide manufacturing facility is located within its Bonthapally manufacturing campus in Medak District, approximately 65 kilometers from Hyderabad International Airport. The peptide facility is part of a larger 17‑acre manufacturing campus, with the first module developed on 5 acres. The overall facility is planned to be constructed in four modules, with Module 1 scheduled to become operational in Q2 FY 2026.
The site supports more than 40 amino acid couplings and integrates precipitation, crystallization, and lyophilization technologies to accelerate development timelines while improving operational efficiency.
This expansion marks Neuland’s strategic entry into commercial‑scale peptide manufacturing, strengthening its ability to support innovator and emerging biotech programs across a broad range of therapeutic areas, including high‑demand peptide modalities. It reflects Neuland’s continued commitment to delivering reliable, high‑quality peptide manufacturing solutions that scale with evolving customer needs—from development through sustained commercial supply.
Highlights
High-Capacity Solid & Liquid Phase Synthesis
- 250–500 L SPPS reactors, with future expansion to 2 × 2 KL SPPS
- Up to 3 KL LPPS capacity, with infrastructure to support multiple 5 KL glass-lined reactors
Large-Scale Purification Systems
- Multiple DAC columns (45 cm and 60 cm) for high-throughput purification
- Expandable to 60 cm or 80 cm DAC systems
Flexible Drying Solutions
- 100 L and 200 L lyophilizers with isolators for controlled drying
- Agitated and pressure Nutsche filter dryers in the intermediate area
Efficient Filtration & Separation
- Tangential Flow Filtration (TFF) and ion exchange columns for enhanced purification efficiency
Advanced Analytical & R&D Capabilities
- Automated peptide synthesizer for consistent and rapid synthesis
- Tray lyophilizer with programmable recipes
- UPLC and HPLC for high-precision analysis
- Coulometry and Karl Fischer for water content analysis
- GC-MS and QTOF-HRMS for detailed molecular characterization
- Circular dichroism and fluorescence spectroscopy for structural analysis
Facility Design & Automation
- Multi-product, multi-modular setup fully automated through Distributed Control System (DCS)
- Designed to scale from tens of kilograms to over 100 kg per year
- Supports over 40 amino acid couplings
- Integrated precipitation, crystallization, spray drying, and lyophilization for faster turnaround and cost efficiency
- Equipped for solid phase synthesis, liquid phase synthesis, and global deprotection processes
Quality, Compliance & Safety
The facility is designed to operate under global cGMP standards (USFDA, EMA, PMDA) with comprehensive QA/QC systems to ensure product integrity and regulatory compliance.
Segregated suites, data integrity systems (21 CFR Part 11 compliant), and in-process controls are in place to guarantee reproducibility and safety.
Environmental and safety commitments are embedded through waste management, green chemistry practices, and EHS compliance, ensuring sustainable operations.
