Infrastructure
At Sai Life Sciences, our manufacturing infrastructure supports projects from gram to multi-ton scale, providing seamless progression from lab-scale development to commercial production. With USFDA, EMA, PMDA, and other global regulatory approvals, clients benefit from a globally benchmarked network. Advanced laboratories, pilot plants, high-potency containment, and automated platforms ensure scalable, reproducible, and compliant operations. Integrated safety systems, process monitoring, and data management enable efficient, phase-appropriate workflows that accelerate development timelines and de-risk technology transfer.
Our Capabilities
Multi-Plant Network
Dedicated cGMP API manufacturing units across India ensuring flexible scale and assured supply continuity.
Flexible Scale
Reactors ranging from lab-scale to 10,000+ L for seamless scale-up.
Global Compliance
Facilities inspected by US FDA, EMA, PMDA, and leading global agencies.
Integrated Quality Systems
Robust data integrity, EHS, and QMS frameworks embedded across all sites.
Reliable Supply Chain
Secure sourcing, logistics, and cold-chain support for global distribution.
Our Capabilities
Multi-Plant Network
Dedicated cGMP API manufacturing units across India ensuring flexible scale and assured supply continuity.
Flexible Scale
Reactors ranging from lab-scale to 10,000+ L for seamless scale-up.
Global Compliance
Facilities inspected by US FDA, EMA, PMDA, and leading global agencies.
Integrated Quality Systems
Robust data integrity, EHS, and QMS frameworks embedded across all sites.
Reliable Supply Chain
Secure sourcing, logistics, and cold-chain support for global distribution.
Technology & Infrastructure
Our state-of-the-art infrastructure supports end-to-end drug development, from discovery to commercial manufacturing. Equipped with advanced laboratories, pilot-scale plants, automated reactors, high-throughput analytical platforms, and formulation suites, we enable scalable, reproducible, and compliant operations. High-potency containment, integrated safety systems, and robust data management ensure regulatory alignment. Modular layouts and flexible equipment allow rapid adaptation across APIs, intermediates, and formulations, supporting efficient, phase-appropriate workflows for seamless progression from lab bench to commercial supply.
Frequently Asked Questions
Yes, Sai Life Sciences has dedicated facilities for discovery, development, and manufacturing across its global network. The integrated R&D campus in Hyderabad spans 12 acres and houses discovery biology labs, medicinal chemistry suites, process development units, and GMP manufacturing blocks for clinical and commercial phases. Additional specialized centers include the Peptide Research Center and Schrödinger Research Labs for advanced modalities. Facilities in Boston and Manchester complement these capabilities, ensuring seamless transitions from early discovery through scale-up and commercial production, all under global safety and compliance standards.
Sai Life Sciences supports manufacturing at multiple scales—lab, kilo, pilot, and commercial—across its global facilities. Early-stage development begins in process R&D labs equipped with versatile reactors (100 mL to 20 L) for lab and pilot work. Their GMP Kilo Lab in Manchester offers gram-to-kilogram scale production with vessels up to 35 L, containment to 1 μg/m³, and analytical support for clinical supplies. For late-phase and commercial manufacturing, the Bidar facility in India provides 450 KL reactor capacity, cryogenic systems, hydrogenators, and lyophilization suites, ensuring seamless scale-up and global compliance.
Yes, Sai Life Sciences’ facilities are fully equipped to handle highly potent compounds (HPAPIs). They operate dedicated HPAPI suites in Hyderabad and Bidar, designed for containment levels below 1 μg/m³ and compliant with SafeBridge Banding 3B standards. These facilities feature isolators, glove boxes, split butterfly valves, and closed systems for all unit operations—dispensing, reaction, purification, drying, and packing. Specialized equipment like Hastelloy reactors, ANFDs, and filter dryers ensures safe, scalable, and compliant manufacturing for oncology and other high-potency therapeutics.
Sai Life Sciences integrates advanced automation and digital systems across its infrastructure to enhance efficiency and compliance. Key technologies include automated parallel synthesizers, EasyMax™ reactors, and Crystal16™ systems for process and particle engineering. Digital platforms like Dynochem and AspenOne support process simulation and scale-up, while PAT tools such as FBRM, PVM, and Blaze enable real-time monitoring and control. These systems are complemented by electronic data capture and analytics for seamless documentation and decision-making, ensuring robust, scalable, and quality-driven operations from discovery through commercial manufacturing.
Sai Life Sciences ensures seamless technology transfer between sites and to external partners through a structured, phase-appropriate approach. Their dedicated team of process engineers and chemists collaborates to design scalable, safe, and economical processes, supported by simulation tools like Dynochem, AspenOne, and MixIT for first-time-right scale-up. Transfers include detailed tech packages covering process chemistry, analytical, and HSE data, pilot studies, and pre-startup reviews. With experience in over 150 successful transfers annually, they mitigate risks through robust documentation, plant walkthroughs, and on-site support, ensuring reproducibility and compliance across geographies.