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Peptide & Microbial Fermentation Development and Manufacturing
With a focus on commercialization, our CDMO team manages end-to-end development processes to reduce timelines and maintain regulatory-grade quality.
Globally licensed cGMP microbial production facility
Operating from Plant 1 in Hyderabad, Amogen's microbial manufacturing infrastructure spans 100L pre-seed through 15,000L production scale — with S. cerevisiae, E. coli and multi-host capabilities available to partners from pre-clinical through commercial supply.
Proprietary platforms.
Built for recombinant precision.
CONTINEXTM
CONTINEX™ is a proprietary continuous fermentation platform for recombinant peptide API manufacturing. Unlike batch processes, it maintains a steady-state fermentation environment — delivering consistent titre, reduced cycle times and a manufacturing footprint that scales from pre-clinical through commercial supply without process changes. Built for upto 10KL production fermenters, CONTINEX™ enables uninterrupted API output at a scale with consistent quality.
Explore manufacturing capabilities
YESTIDETM
YESTIDE™ is a proprietary yeast-based expression system for the development and manufacturing of GLP-1, GIP-GLP Dual Agonists peptide APIs. Using our system, it delivers the higher-order structure, salt-free purity profile and regulatory alignment that synthetic SPPS routes cannot replicate. Our Tirzepatide biosimilar program in pipeline is expressed through YESTIDE™ giving partners a structural and regulatory trust that begins at the molecule level.
See our pipeline programsBringing your recombinant science to life
At Amogen Pharma, we specialize in producing biopharmaceuticals based on microorganisms throughout from initial strain engineering through GMP manufacturing and regulatory filing — Amogen's microbial fermentation platform covers the full development journey for peptide and protein biosimilars, in one facility, under one quality system
- Genetic engineering, cell line and strain development in E. coli and yeast
- High-cell-density fermentation with E. coli expression systems
- Soluble expression in E. coli with increased titers for Fabs
- Inclusion body purification techniques at clinical and commercial scale
- Chemical modifications to extend half-life, e.g. PEGylation or albumin-fusion
- 75,000 L overall production capacity for clinical and commercial supply, with 4 10,000 L trains
- Protein refolding and purification-only for all kinds of recombinant proteins
- High-Performance Liquid Chromatography (HPLC) at clinical and commercial scale
- Plasmid-based gene expression systems for E. coli and yeast
- Explosion-proof facilities to handle organic solvents for sensitive peptides
- GMP batch release testing
- Bioassays and ELISA
- Microbiology
- Cell and Molecular Biology
- Raw material testing
- TOC and Photometry
- DNA lab
- Electrophoresis
- Chromatography
- Virology
- IPC support
Early-stage molecule optimization and developability assessment to de-risk your pipeline.
Strain Development
Proprietary platform processes for high-expressing, stable cell line generation.
Cell Line Development
Scalable upstream and downstream process development from bench to commercial scale.
Process Development
Comprehensive analytical method development, qualification, and transfer capabilities.
Analytical Development
Flexible manufacturing from non-GMP toxicology to CGMP clinical and commercial supply.
Non-GMP/CGMP Manufacturing
Integrated GMP Quality Systems and Digital Infrastructure
Our Quality team manages GMP assurance and control across the full manufacturing lifecycle at Plant 1, Hyderabad. Integrated digital platforms like EQUIS, LMS and LIMS — ensure proactive quality management and full traceability from raw material to batch release.
Our Electronic Quality Management System (eQMS) supports change control, documentation management, and event tracking across all CDMO services. This infrastructure enhances compliance, efficiency, and transparency throughout the quality lifecycle.
The LMS platform ensures consistent GMP training, qualification tracking, and certification for all personnel. This system supports our commitment to quality assurance services by keeping our workforce aligned with regulatory standards.
LIMS supports round-the-clock data integrity and testing workflows in quality control testing. It provides centralized access to lab data, enabling better decision-making in Analytical Development and regulatory filings.
Built to global GMP standards.
Every program developed and manufactured at Plant 1 operates under a unified quality system — from first strain engineering through batch release.
ICH Compliance
All development and manufacturing activities conducted in compliance with ICH Q7, Q8, Q9 and Q10 guidelines — from process development through commercial supply.
Schedule M GMP
Plant 1, Hyderabad operates under revised Schedule M GMP standards. WHO-GMP inspection preparation currently underway.
ICH-Compliant Pre-Clinical
GLP-compliant repeat-dose toxicity study completed November 2025. ICH-compliant GLP report available to qualified partners under NDA.
Analytical Compliance
All testing conducted per ICH Q2(R1), FDA and EMA guidelines with full method validation, qualification and documentation.
YESTIDE and CONTINEX are trademarks of Amogen Pharma Private Limited. Trademark registration pending.
Analytical Testing Capabilities
With extensive GxP experience and advanced analytical platforms, we provide comprehensive testing services across the entire process — from raw materials to final drug product. All testing, including method transfer, validation, and qualification, is conducted in full compliance with ICH Q2(R1), FDA, EMA, PMDA and other relevant guidelines, ensuring reliable and consistent results that support on-time batch release.
IPC & Release Testing
Our QC team performs critical In-Process Control (IPC) and Drug Substance/Drug Product (DS/DP) Release Testing to ensure product quality and regulatory compliance throughout the manufacturing process.
Stability Study & Testing
We maintain controlled areas that have validated and monitored stability chambers suitable for the generation of GMP Drug Substance and Drug Product stability data. Physical and kinetic stability profiles are generated with real-time storage conditions, accelerated conditions, and stressed conditions (with temperature/humidity and/or light), in full compliance with ICH guidelines.
Environmental Monitoring
Through our routine testing of facility-related samples (environmental monitoring, water systems, clean steam, clean gas, etc.), we ensure that our controlled environments are maintained for the manufacturing of high-quality products.
Science & Insights
Technical perspectives from Amogen's scientific team — on recombinant fermentation, biosimilar development, regulatory strategy and the evolving GLP-1 market.
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