Shilpa CDMO is committing $50 million to expand its peptide manufacturing infrastructure in India, adding production capacity and specialized capabilities to support growing demand for GLP-1 drugs and increasingly complex peptide-based therapeutics.

The investment will be implemented in phases over the next several years and add 10 kiloliters (KL) of solid-phase peptide synthesis (SPPS) reactor capacity to the company’s three existing clinical manufacturing lines. A fourth line, designed for commercial production at Shilpa’s Unit-I campus in Raichur, Karnataka, is scheduled to begin operations in December 2026, with commercial supply expected to ramp up throughout 2027.

Additional capacity will include 2 KL, 3 KL and 5 KL SPPS reactors. Once completed, the expansion is expected to establish one of India’s largest multi-ton peptide manufacturing platforms.

The new commercial line will feature 500-liter and 1,000-liter reactors within a single production block, supporting annual output of up to one metric ton. Downstream processing capabilities will include two 2-meter dynamic axial compression (DAC) columns, a preparative high-performance liquid chromatography (HPLC) system with 10,000 liters per hour capacity, 1,000-liter-per-hour nanofiltration and a 1,000-liter-capacity lyophilizer.

The expanded operation will comprise six parallel current Good Manufacturing Practice (cGMP) production lines, allowing multiple customer programs to be manufactured independently. The platform will support solid-phase peptide synthesis, liquid-phase peptide synthesis (LPPS) and hybrid approaches combining both methods.

Capabilities will cover linear, cyclic and branched peptides, including molecules containing unnatural and D-amino acids, as well as lipidated, conjugated and radioligand peptides. The company is also building on existing expertise in cytotoxic peptides and peptide conjugates, with one manufacturing line dedicated to cytotoxic peptide production using SPPS.

Keshav Bhutada, CEO of Shilpa CDMO, says the investment is intended to address demand beyond the current GLP-1 market, particularly as drug developers advance more sophisticated peptide candidates for oncology and rare diseases. He noted that these molecules can require specialized expertise in synthesis, purification, route development and scale-up.

The company aims to provide customers with manufacturing support spanning early development through commercial production, with processes designed around the technical requirements and anticipated production volumes of individual molecules.

Dipak Kalita, Senior Vice President of CDMO Services at Shilpa CDMO, emphasizes the importance of selecting an appropriate synthesis strategy early in development. Longer and more complex peptides may require a transition from conventional solid-phase synthesis to hybrid, fragment-based approaches as production volumes increase.

Kalita says evaluating commercial manufacturing requirements from the outset can help developers avoid reaching later development stages with processes that are difficult or uneconomical to scale.

Shilpa’s peptide business currently employs more than 100 scientists and manufacturing specialists. Its research and development organization includes more than 50 scientists focused on peptide chemistry, while 45 chemists work across production and purification. The team also draws on the broader Shilpa group’s network of more than 350 PhDs.

The peptide operation is located within the company’s 34-acre Unit-I campus in Raichur. The wider site houses dedicated research and cGMP manufacturing infrastructure for active pharmaceutical ingredients (APIs), commercial linkers, highly potent APIs (HPAPIs) across occupational exposure bands 1 through 6, and peptide-drug conjugates.

To support process development and commercial scale-up, the new facility will incorporate a centralized distributed control system (DCS), integrated process analytical technology (PAT) and UV monitoring. Design of Experiments (DoE) and process simulation will be used to establish operating parameters before scale-up and technology transfer. Automated data capture is also intended to strengthen data integrity and regulatory compliance.

For more information, visit www.shilpapharma.com.