Shilpa CDMO, a complex chemistry contract development and manufacturing organization (CDMO), is investing $50 million to expand its peptide manufacturing capabilities. The investment comes as global demand for GLP-1 therapies and a new generation of complex peptide-based medicines continues to grow. Through this expansion, the company aims to strengthen its position in the global peptide manufacturing market and support pharmaceutical and biotechnology companies with development and commercial-scale manufacturing solutions.
Expanding Peptide Manufacturing Capacity
Shilpa CDMO will implement the investment in phases over the next few years, adding 10 KL of solid-phase peptide synthesis (SPPS) reactor capacity to its three existing clinical-phase manufacturing lines. The company has scheduled the opening of its fourth manufacturing line, dedicated to commercial production, at its Raichur Unit-I campus in December 2026. It expects commercial supplies to ramp up through 2027. Furthermore, Shilpa CDMO plans to install additional 2 KL, 3 KL and 5 KL SPPS reactors. Once completed, these additions will establish one of India’s largest multi-tonne peptide manufacturing capacities.
Advanced Infrastructure for Commercial Production
The new commercial manufacturing line will feature 500 L and 1,000 L reactors within a single production block, supporting annual output of up to one metric tonne.
The facility will also incorporate advanced purification and processing infrastructure, including:
Two 2-metre dynamic axial compression (DAC) columns.
A 10,000 LPH preparative high-performance liquid chromatography (HPLC) system.
A 1,000 L/hr nanofiltration system.
A large-scale lyophilizer with 1,000 L capacity.
In addition, the expansion builds on Shilpa’s existing capabilities in cytotoxic products and peptide conjugate development. One of its manufacturing lines is dedicated to cytotoxic peptide production using solid-phase peptide synthesis.
Addressing Growing Demand for Complex Peptide Therapeutics
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,” Bhutada added.
Six Parallel Manufacturing Lines and Flexible Synthesis Capabilities
Following the expansion, Shilpa CDMO’s peptide operations will comprise six parallel current Good Manufacturing Practice (cGMP) manufacturing lines. This infrastructure will allow the company to execute multiple manufacturing programmes independently.
The platform will support three major synthesis approaches:
Solid-Phase Peptide Synthesis (SPPS): Enables peptide production through sequential addition of amino acids on a solid support.
Liquid-Phase Peptide Synthesis (LPPS): Provides an alternative approach for manufacturing suitable peptide molecules.
Hybrid Synthesis (SPPS + LPPS): Combines both methods to optimize manufacturing efficiency and scalability.
These capabilities will support the production of linear, cyclic and branched peptides, including molecules incorporating unnatural and D-amino acids, lipidation, conjugation and radioligand peptides.
Strengthening Scientific and Manufacturing Expertise
Shilpa CDMO’s peptide business currently employs more than 100 scientists and manufacturing specialists. This includes an R&D team of over 50 professionals specializing in peptide chemistry and 45 chemists working across production and purification. Additionally, the team benefits from the wider Shilpa Group’s scientific expertise, which includes more than 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,” Kalita added.
Advanced Manufacturing Infrastructure at Raichur
Shilpa CDMO operates its peptide manufacturing facilities within its 34-acre Unit-I campus in Raichur, Karnataka. The wider site houses dedicated R&D and cGMP manufacturing infrastructure for active pharmaceutical ingredients (APIs), commercial linkers, highly potent active pharmaceutical ingredients (HPAPIs) across occupational exposure bands (OEB) 1–6, and peptide drug conjugates.
Moreover, the new peptide facility will feature a centralized Distributed Control System (DCS), integrated Process Analytical Technology (PAT) and ultraviolet (UV) monitoring. As per the press release, the company will also use Design of Experiments (DoE) and process simulation to establish operating parameters before scale-up and technology transfer. Meanwhile, automated data capture will strengthen data integrity and support regulatory compliance.
