HPAPI cGMP Manufacturing

4. cGMP Manufacturing

Purpose & What We Do

•Deliver clinical-grade and commercial-grade HPAPI batches under full cGMP, following all regulatory guidelines
•Maintain consistency, compliance, safety, and traceability across production

Key Activities

•Use of dedicated HPAPI suites with isolator / barrier equipment, strict air handling, OEL level control. (Shilpa has 10 cGMP HPAPI suites capable of very low OELs < 0.01 µg/m³ for ADC payloads/payloads & linkers)
•Full documentation: batch records, quality control, cleaning validation, validation of process & analytical methods
•QC release: potency, purity, stability, residual solvents, heavy metals, impurity profiles, moisture etc.
•Packaging, containment, transportation in compliance with hazardous material standards

Deliverables

•cGMP HPAPI batches for Phase I / II / III and commercial use
•Regulatory ready dossiers (DMF / CEP / IND etc.)
•Full safety and compliance documentation

High-Containment Manufacturing Infrastructure

Nine dedicated blocks engineered to OEL-4, with single-pass HVAC and terminal HEPA filtration, closed transfer and split-butterfly valve systems, contained milling and micronisation, and isolator-based dispensing and sampling. Segregated effluent is routed to zero liquid discharge treatment. This infrastructure supports multi-tonne high-potency API capacity — a scale few contract manufacturers can offer in containment.

Capacity Available at Raichur

Site	Blocks	Reactor Volume	Suitable For
API Unit I, Deosugur, Raichur	11 (4 oncology, 7 non-oncology)	~650 KL	HPAPI, oncology, NCE, peptides, polymers
API Unit II, Raichur Growth Centre (100% EOU)	10 (5 oncology, 5 non-oncology)	~510 KL	Non-oncology, specialty, custom synthesis, CRAMS

Commercial Supply & CRAMS

Beyond development and manufacturing, Shilpa Pharma Lifesciences provides CRAMS (contract research and manufacturing services) from its Raichur facilities — route scouting, process development, custom synthesis, scale-up, validation and commercial supply. Long-term supply agreements, capacity reservation, second-source qualification and supply security planning are available for commercial-stage programmes.

cGMP Manufacturing

Overview