Shilpa CDMO has announced a $50m investment to boost its peptide manufacturing capabilities, citing growing global demand for GLP-1s and new generations of complex peptide therapeutics.
The investment follows the firm's launch as a dedicated complex-molecule CDMO brand last month.
GLP-1 and growing pipelines fuel global peptide crunch
With shortages of specific brand-name injectable therapies triggering multi-year production lags, contract manufacturers have poured billions into new plants and upgraded capacity at existing ones to increase peptide manufacturing capacity
While raw API supply has partially stabilised, aseptic fill-finish has become the main bottleneck in the production process, requiring highly specialised cleanroom environments that can take years to build out and strict regulatory approvals.
Additionally to GLP-1s, a growing number of peptide candidates are moving through preclinical and clinical trials, creating bottlenecks for traditional batch manufacturing facilities.
These developments in oncology, rare diseases, peptide-drug conjugates (PDCs), cyclic peptides and peptide-oligonucleotide hybrids require more sophisticated manufacturing scale-ups, as they feature more complex designs.
These can require specialised backbone-protecting groups, microwave-assisted coupling and advanced purification platforms to prevent aggregation and poor yields.
The phased investments will take place during the next few years, adding 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 already scheduled to open in December this year, with commercial supply ramping up through 2027.
The CDMO said that it plans to add further 2 KL, 3 KL and 5 KL SPPS reactors, which will establish one of the largest multi-tonne peptide capacities in India.
The new commercial line features 500 L and 1000 L reactors configured in a single unit, capable of supporting annual production of up to one metric tonne.
The purification process includes two 2-meter differential absorbance chromatography (DAC) columns and a preparative high-performance liquid chromatography (HPLC) system with a capacity of 10,000 litres per hour.
Additionally, the line will incorporate a 1000 liters per hour nanofiltration system and a large-scale lyophilizer with a capacity of 1000 liters.
Shilpa added that one production line will be dedicated to manufacturing cytotoxic peptides using solid-phase peptide synthesis.
Keshav Bhutada, CEO 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.”
The CDMO's expanded peptide manufacturing operation will consist of six parallel cGMP manufacturing lines, which it says will allow for multiple programmes to run independently.
The platform will support SPPS, liquid-phase peptide synthesis (LPPS) and hybrid synthesis (SPPS + LPPS), allowing manufacturing routes to be tailored to the molecule, its development stage and intended commercial scale.
Capabilities span linear, cyclic and branched peptides.
Dipak Kalita, Senior Vice President – CDMO Services at Shilpa CDMO, added: “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 a solid-phase, liquid-phase, or 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 new peptide facility features a centralised Distributed Control System (DCS) equipped with integrated Process Analytical Technology (PAT) and UV monitoring.
To determine operating parameters before scale-up and technology transfer, Shilpa CDMO says it uses Design of Experiments (DoE) and process simulation.
Additionally, automated data capture will enhance data integrity and ensure regulatory compliance.
