Piramal Pharma Solutions has expanded its dedicated peptide development and manufacturing facility in Turbhe, India, with a new spray drying suite designed to support complex and highly potent molecules.

New suite adds spray drying capability

The new facility includes Band 5 containment capacity and is equipped with dedicated air handling units, nitrogen supply and control systems.

The suite is designed to support the formulation and processing of challenging molecules, including peptides, highly potent active pharmaceutical ingredients (HPAPIs) and other biomolecules.

Spray drying converts liquid formulations into dry powders in a single process and can be used to control particle size, improve bioavailability and support the processing of sensitive compounds.

The technology is particularly relevant to peptide development because peptides can be sensitive to temperature and other processing conditions.

Piramal Pharma Solutions said the new capability can support formulation development by allowing control over factors including temperature and solvent conditions, while also helping with solubility and scale-up.

Facility designed for potent compounds

The spray drying suite operates as a closed-loop system and includes a dedicated inert gas supply and safety systems designed for the handling of potent compounds and organic solvents.

The facility includes specialised HVAC systems, airlocked entries and exits, operator isolation and a dedicated cleaning area.

The processing area operates to ISO Class 8 cleanliness standards, providing controlled environmental conditions during manufacturing operations.

The suite is designed for small-volume, high-potency batches and can process feed rates of up to 1 litre per hour.

It can also spray dry highly concentrated solutions containing up to 30% water, which Piramal Pharma Solutions said could make the technology suitable for biomolecules and large peptides.

Under suitable processing conditions, the equipment can also be used for low-volume small-molecule formulations.

Dr Jordi Bacardit, global technical lead on peptides at Piramal Pharma Solutions, said: “Peptides present some of the most intricate formulation challenges in pharmaceutical development, owing to their inherent instability and sensitivity to processing conditions.”

He added: “Spray drying addresses these distinct challenges by allowing tight control over key components like temperature and solvent environment.”

Peptide manufacturing capabilities expand

The addition of spray drying capability adds another formulation technology to Piramal Pharma Solutions’ peptide development and manufacturing operations.

Peptide-based medicines have become an increasingly important part of pharmaceutical development, with drug developers working on treatments across a range of therapeutic areas.

Their development and manufacture can present specific challenges because of the stability and processing characteristics of peptide molecules.

The new suite is intended to support projects involving peptides, HPAPIs and other complex molecules from development through to manufacturing.

The facility’s containment capabilities are also relevant to the growing use of highly potent compounds in pharmaceutical development, where specialised equipment and controlled processing environments are required to protect operators and maintain product quality.

The Turbhe site forms part of Piramal Pharma Solutions’ global contract development and manufacturing organisation (CDMO) network.

The company said the new spray drying capability will allow its teams to support formulation development for complex molecules while providing controlled processing conditions for small-volume and high-potency batches.

The expansion comes as pharmaceutical developers continue to explore peptides and other complex molecules for new medicines, increasing demand for specialised formulation and manufacturing capabilities.