Shilpa CDMO invests $50 million to expand peptide manufacturing capacity

Shilpa CDMO is investing $50 million to expand its peptide manufacturing capabilities as demand for GLP-1s and peptide therapeutics increases.

The phased investments will span the next few years and add 10 KL of solid-phase peptide synthesis (SPPS) reactor capacity to the three existing clinical-phase manufacturing lines. A fourth line for commercial manufacturing at Shilpa’s Raichur Unit-I campus is scheduled to open in December 2026, with commercial supply expected to ramp up through 2027.

The CDMO plans to add further 2 KL, 3 KL and 5 KL SPPS reactors, establishing one of the largest multi-tonne peptide capacities in India.

The new commercial line features 500 L and 1,000 L reactors in a single block, supporting annual production of up to one metric tonne. Its purification infrastructure includes two 2-metre DAC columns with a 10,000 LPH preparative HPLC system. The line will also include 1,000 L/hr nanofiltration and a lyophiliser with a capacity of 1,000 L.

The expansion builds on Shilpa’s existing cytotoxic and peptide conjugate product development capabilities, with one line dedicated to cytotoxic peptide manufacturing using SPPS.

Keshav Bhutada, Chief Executive Officer, 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 operations will comprise six parallel cGMP manufacturing lines, allowing multiple programmes to run independently. The platform supports solid-phase peptide synthesis (SPPS), liquid-phase peptide synthesis (LPPS) and hybrid synthesis (SPPS + LPPS), allowing manufacturing routes to be selected according to the molecule, its development stage and intended commercial scale.

Its capabilities cover linear, cyclic and branched peptides, including molecules incorporating unnatural and D-amino acids, lipidation, conjugation and radioligand peptides.

More than 100 scientists and manufacturing specialists work within Shilpa’s peptide business. This includes an R&D team of more than 50 members dedicated to peptide chemistries and 45 chemists working across production and purification. The team is also supported by the wider Shilpa Group’s more than 350 PhDs.

Dipak Kalita, Senior Vice President – CDMO Services, 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”.

Shilpa CDMO’s peptide operations are based at its 34-acre Unit-I campus in Raichur, Karnataka. The peptide unit operates within the wider site, which has dedicated R&D and cGMP manufacturing infrastructure for APIs, commercial linkers, HPAPIs spanning OEB 1-6 and peptide drug conjugates.

The new peptide facility also has a centralised Distributed Control System (DCS), with integrated Process Analytical Technology (PAT) and UV monitoring. Design of Experiments (DoE) and process simulation will be used to establish operating parameters ahead of scale-up and technology transfer, while automated data capture will support data integrity and regulatory compliance.

The investment follows the launch of Shilpa CDMO as a dedicated complex-molecule CDMO brand in October 2026.

Shilpa CDMO is the customer-facing brand of Shilpa Pharma Lifesciences

The post Shilpa CDMO invests $50 million to expand peptide manufacturing capacity appeared first on Express Pharma.