Neuland Laboratories has accelerated its peptide manufacturing expansion with the commencement of operations at the first of four planned modules at its commercial peptide manufacturing site. The first module has a total reactor capacity of 7,000 litres, including 750 litres of solid-phase peptide synthesis (SPPS) capacity and 6,250 litres of liquid-phase peptide synthesis (LPPS) capacity. The facility is designed to support customer programmes ranging from small-scale production to multikilogram quantities of complete peptide active pharmaceutical ingredients (APIs), including complex and long-chain peptides, as well as commercial-scale production of crude peptides.
The SPPS and LPPS reactors are housed in separate suites, allowing parallel operations. The module is supported by three DAC columns, comprising one 45 cm column and two 60 cm columns, along with two lyophilisers with capacities of 100 litres and 200 litres.
Neuland invested approximately $30 million in the first module. With the foundational infrastructure for the second module already in place, the company expects to begin work ahead of its original schedule once customer requirements are finalised.
The configuration, instrumentation and capacity for the second module are being defined in collaboration with the customer whose projects will anchor the expanded capability. Module two is planned to provide total reactor capacity of up to 18,000 litres. The proposed configuration includes three 5,000-litre LPPS reactors, either a 1,000-litre or 2,000-litre SPPS reactor, and smaller reactors of up to 1,000 litres.
The flexible configuration is intended to allow Neuland to support peptide development and manufacturing programmes across different scales. The company said customer indications are also expanding beyond obesity and metabolic diseases, with oncology emerging as an active area of early-stage development.
Saharsh Davuluri, CEO and Managing Director, Neuland Laboratories, said, “Our goal is to ensure we have the capacity to meet customer demand not just over the next 24 months, but over the next decade, as we deepen our strategic partnerships with leading pharma and biotech companies.”
The first module is supported by a team of nearly 212 peptide specialists. Neuland said the expansion is being undertaken in response to increasing demand for outsourced peptide development and commercial manufacturing capacity as pharmaceutical and biotechnology companies expand their peptide pipelines. The company is also evaluating options to address medium-term and future demand as customer programmes increase in scale.
Neuland Laboratories is a specialist API contract development and manufacturing organisation serving pharmaceutical and biotechnology companies. The company provides process development and commercial supply services for complex molecules and new chemical entities and serves customers in more than 80 countries.
Neuland operates three US FDA- and EU GMP-compliant facilities in India, with combined reactor capacity of approximately 1,218 kL. The company is also developing a dedicated R&D process development centre in Hyderabad. Neuland has filed more than 1,000 drug master files globally and offers more than 100 APIs across multiple therapeutic areas. The company is listed on the NSE and BSE in India.
