Shilpa CDMO has announced a $50 million investment to expand its peptide manufacturing capabilities, responding to growing global demand for GLP-1s and increasingly complex peptide therapeutics. The phased expansion, planned over the next few years, will add 10 KL of solid-phase peptide synthesis (SPPS) reactor capacity alongside the company’s three existing clinical-phase manufacturing lines.
The first commercial manufacturing line, located at Shilpa’s Raichur Unit-I campus, is scheduled to become operational in December 2026, with commercial supply expected to increase through 2027. The investment will also introduce additional 2 KL, 3 KL and 5 KL SPPS reactors, positioning the company to establish one of India’s largest multi-tonne peptide capacities.
The new commercial facility will feature 500 L and 1,000 L reactors within a single manufacturing block, supporting annual production of up to one metric tonne. Its purification infrastructure will include two 2-metre DAC columns alongside a 10000 LPH preparative HPLC system. Additional equipment will comprise 1000L/hr nano filtration and a large-scale lyophilizer with 1000 L capacity. The expansion builds on Shilpa’s existing capabilities in cytotoxic and peptide conjugate product development, including a dedicated line for cytotoxic peptide manufacturing using solid-phase peptide synthesis.
Keshav Bhutada, Chief Executive Officer of Shilpa CDMO, said: “Peptides are becoming one of the most important areas of pharmaceutical development, but the opportunity goes well beyond current GLP-1 demand. Innovator pipelines in oncology and rare diseases are producing increasingly sophisticated molecules and conjugates that require much greater expertise in route design, synthesis, purification and scale-up.
We are investing for where the peptide market is going next. Our aim is to give biotech and pharmaceutical partners a platform that can take challenging peptide programmes from early development through to reliable commercial supply.”
Shilpa CDMO’s expanded peptide operation will comprise six parallel cGMP manufacturing lines, enabling multiple programmes to operate independently. The platform will support solid-phase peptide synthesis (SPPS), liquid-phase peptide synthesis (LPPS) and hybrid synthesis (SPPS + LPPS), allowing production routes to be selected according to molecular characteristics, development stages and intended commercial volumes. Its technical capabilities cover linear, cyclic and branched peptides, including molecules containing unnatural and D-amino acids, lipidation, conjugation and radioligand peptides.
The company currently employs more than 100 scientists and manufacturing specialists in its peptide business. This includes an R&D team of more than 50 specialists focused on peptide chemistries and 45 chemists working across production and purification, supported by the wider Shilpa group’s 350+ PhDs. Dipak Kalita, Senior Vice President – CDMO Services at Shilpa CDMO, said: “As peptides become longer and more complex, the manufacturing route can determine whether a programme can scale successfully.
We start with the molecule and its potential commercial requirements, then determine whether solid-phase, liquid-phase or a hybrid approach offers the most robust route. For longer peptides, that can mean moving from solid-phase synthesis to a hybrid fragment based route as volumes grow. Considering commercial scale from the outset helps customers avoid reaching late-stage development with a process that is no longer technically or economically viable”.
The company’s peptide operations are located at its 34-acre Unit-I campus in Raichur, Karnataka. The wider site houses dedicated R&D and cGMP manufacturing infrastructure for APIs, commercial linkers, HPAPIs spanning OEB 1-6 and peptide drug conjugates. The new facility will also incorporate a centralised Distributed Control System (DCS), integrated Process Analytical Technology (PAT) and UV monitoring. Design of Experiments (DoE) and process simulation will support the establishment of operating parameters before scale-up and technology transfer, while automated data capture is intended to maintain data integrity and regulatory compliance. The $50 million investment follows the launch of Shilpa CDMO as a dedicated complex-molecule CDMO brand in October 2026.
