Neuland Labs expands peptide manufacturing capacity in India

The first of the CDMO’s four planned modules is now operational, adding 7,000 liters of reactor capacity for peptide API development and commercial manufacturing.

Neuland Laboratories, an active pharmaceutical ingredient (API) manufacturer and contract development and manufacturing organization (CDMO) based in Hyderabad, India, has begun operations for the first module of its commercial peptide manufacturing site as it expands capacity to support customer programs.

The newly operational module provides 7,000 liters of total reactor capacity, including 750 liters for solid-phase peptide synthesis (SPPS) and 6,250 liters for liquid-phase peptide synthesis (LPPS). The capacity supports peptide API programs ranging from small-scale development through multikilogram production, including complex and long-chain peptides, as well as commercial-scale production of crude peptides, according to the company.

SPPS and LPPS reactors are housed in separate suites to allow parallel operations. The module also includes three dynamic axial compression columns — one 45-centimeter and two 60-centimeter columns — and two lyophilizers with capacities of 100 liters and 200 liters.

Neuland invested $30 million in the first module. Infrastructure for a second module is already in place, and the company plans to begin work ahead of its original timeline once customer requirements are finalized. The configuration, instrumentation, and capacity of the second module are being defined with the customer whose projects will use the expanded capacity.

The second module is planned to provide up to 18,000 liters of reactor capacity, including three 5,000-liter LPPS reactors, a 1,000-liter or 2,000-liter SPPS reactor and smaller reactors up to 1,000 liters. Neuland said the configuration will allow it to support peptide programs at different development and production scales.

The company said demand from customers is expanding beyond obesity and metabolic disease programs, with oncology emerging as another area of early-stage peptide development. The first module is supported by a team of nearly 212 peptide specialists.

The peptide expansion follows Neuland’s recent expansion of its sterile API manufacturing network. In August, Neuland entered a long-term partnership with Gland Pharma to add a dedicated sterile API manufacturing suite at Gland’s facility in Visakhapatnam, India. The suite is expected to provide approximately 1,400 kilograms of annual capacity for microparticle depot products and other complex sterile APIs, with manufacturing designed to meet cGMP, U.S. FDA and European Union requirements.

Neuland said it is also evaluating additional options to expand peptide manufacturing capacity as customer demand develops, with the company planning its capacity requirements over the longer term.

This piece was created with the help of generative AI tools and edited by our content team for clarity and accuracy.
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