Piramal Pharma Solutions expands peptide API facility with advanced spray drying suite

Piramal Pharma Solutions has launched a closed-loop spray drying suite at its dedicated peptide facility in Turbhe, adding single-step conversion of liquid peptide APIs into dry powders at feed rates up to 1 liter per hour. The suite handles solutions with up to 30% water and meets Band 5…

Piramal opens spray drying suite inside its Turbhe peptide facility

Piramal Pharma Solutions PPS has launched an advanced closed-loop spray drying suite at its dedicated peptide development and manufacturing facility in Turbhe, expanding the contract development and manufacturing organization's peptide API formulation capabilities. The suite converts liquid formulations into dry powders in a single step and is engineered for small-volume, high-potency batches.

PPS, described by the company as a leading global CDMO and part of Piramal Pharma, said the expansion is intended to address complex formulation challenges for peptides and other complex molecules and to support growing demand for those molecules. The Turbhe site already houses the dedicated peptide development and manufacturing capacity; the spray drying suite is the new element added to it. The company has not described what spray drying capability, if any, existed at the facility before.

The headline specifications are precise. The suite supports a maximum feed rate of 1 liter per hour, can process highly concentrated solutions containing up to 30% water, and is designed for safe handling of potent compounds and organic solvents requiring up to Band 5 containment. The processing area maintains ISO Class 8 , or Class 100,000, cleanliness standards.

A small-scale unit built for concentrated, potent feeds

The key specifications of the new suite are:

The 30% water limit deserves close attention. Spray drying feeds are often organic solvent solutions or dilute aqueous buffers, and building a concentrated aqueous feed is itself a formulation challenge. PPS said the ability to spray dry solutions containing up to 30% water is valuable for biomolecules and large peptides, which are often difficult to concentrate or to transfer into organic solvents without losing activity. Under optimal conditions, the suite can also be used for low-volume small-molecule formulations.

The company described the technique as gentle and efficient, helping to improve solubility, accelerate scale-up, and increase processing speed while preserving the molecular integrity of peptide APIs. The announcement lists a company address, Ashirwad Bungalow, First floor, 36/A/2, S.No. 270, Pallod Farms, Near Bank of Baroda, Baner Road, Pune, Maharashtra, India 411045, but it does not explicitly identify that address as the Turbhe facility address.

Why spray drying suits heat-sensitive peptide APIs

Spray drying atomizes a liquid feed into fine droplets inside a chamber of heated gas. Solvent evaporates rapidly from the droplet surfaces, and the remaining solids form dry particles that are collected downstream. Because each droplet is small, drying is fast and the residence time at elevated temperature is short, so the process can be gentle despite relying on heat.

That combination matters for peptides. Peptides are unstable at high temperatures and often require strict control over particle properties. The degradation pathways are well characterized: heat drives deamidation of asparagine and glutamine residues, oxidation of methionine and cysteine, and aggregation of partially unfolded chains. A drying process that minimizes thermal exposure while still removing water is therefore attractive for peptide APIs, and the company cited exactly this rationale.

The stated benefits of the technique for this class are specific: enhanced bioavailability, precise particle size, and safe processing of sensitive compounds. Bioavailability follows from particle engineering, because spray drying can produce amorphous solids or defined particle size distributions that dissolve more readily than crystalline material. Precise particle size also determines performance in delivery routes where aerodynamic or geometric diameter matters, such as inhalation, and in suspension formulations where uniformity and settling depend on the powder.

The 30% water ceiling defines the operational envelope for this effect. Water has a high heat of vaporization, so drying an aqueous feed demands more energy and tighter control than drying an organic solution. The ability to spray dry feeds with up to 30% water means concentrated aqueous peptide solutions can be processed directly, without a solvent exchange step that could denature large peptides or drive aggregation. For large peptides and biomolecules, that removes a unit operation between the production train and the dry powder.

Closed-loop operation, Band 5 containment, and cleanroom limits

The containment story matters as much as the drying physics. The suite is a closed-loop system with its own inert gas supply, which typically means a recirculating gas such as nitrogen. That design serves two functions. It excludes oxygen from the drying atmosphere, protecting oxidation-prone peptides, and it confines organic solvent vapors inside the system, reducing flammability risk and keeping potent material out of the workroom.

The safety package includes specialized HVAC, airlocked entries and exits, operator isolation, and a dedicated cleaning area. Those features enable safe handling of potent compounds and organic solvents requiring up to Band 5 containment, the highest of the widely used occupational exposure levels. Materials in that band call for closed processing with no open handling steps, because even trace airborne exposure can be hazardous.

The ISO Class 8 designation places the processing area in a controlled non-aseptic grade, equivalent to the older Class 100,000 standard. The distinction matters for scientists assessing the suite. ISO Class 8 permits monitored clean environments for secondary processing, equipment staging, and powder handling, but it does not by itself enable aseptic processing. A spray dried powder destined for a sterile parenteral product would still require downstream sterilization or aseptic filling under far stricter conditions. The closed-loop design does, however, reduce contamination risk to both product and environment during the drying step.

What the capability means for developers and the supply chain

For peptide sponsors, the suite removes a capital barrier. Formulation scientists can test dry powder approaches, particle engineering strategies, and excipient systems at a dedicated peptide CDMO without commissioning their own drying equipment. The 1 liter per hour scale is small enough to screen many conditions quickly and large enough to generate material for early toxicology and clinical studies.

The single-step process is a practical advantage over lyophilization , the dominant alternative for drying peptide products. Freeze drying is a multi-step batch process with long cycle times and high energy costs. Spray drying collapses drying into one step and, at development scale, allows rapid iteration across variables such as solids content, atomization rate, and inlet temperature. The company's claims of increased speed and preserved molecular integrity point at this comparison, though PPS has not published comparative data.

For the supply chain, the addition responds to a real constraint. Peptide formulation capacity, not just synthesis capacity, has become a bottleneck as the therapeutic class has expanded from naturally derived hormones toward engineered molecules with modified backbones and improved stability. A CDMO that develops the peptide API and then converts it to a dry powder under high containment offers sponsors a single partner for both steps, reducing handoffs for potent programs. The Band 5 design broadens the addressable set to highly potent peptides and other complex molecules that cannot be processed in open drying equipment.

What the announcement does not establish

The launch announcement leaves several questions open. It does not specify when the suite became operational, so the capability is new to the public record but its first-use date is unknown. It names no specific peptide compounds, clients, or development programs, which means the suite's pipeline cannot be assessed from public information. It also does not describe any spray drying capability that existed at Turbhe before.

The stated feed rate and water-content limits are engineering capabilities, not demonstrated batch performance. The distinction matters. A maximum feed rate of 1 liter per hour describes what the pumps and atomizer can deliver; it says nothing about achievable yield, residual moisture, particle size distribution, or impurity profile under routine operation. The 30% water ceiling is an input specification, not evidence that a large peptide has been dried successfully at that concentration.

Open questions would be settled by specific disclosures. An operational start date and named development programs would come from the company itself. Process characterization data, including yields, moisture content, particle size distributions, and impurity profiles across a range of peptide molecular weights, would show whether the engineering limits translate into routine capability. Comparative studies against lyophilization and other particle engineering technologies, such as spray congealing or supercritical fluid processing, would position the suite against alternatives. Until such data appear, the investment is best understood as an enabling step whose output remains to be demonstrated.

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