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SMART First Human Dose, with PCI Pharma Services

The core concept of PCI’s SMART FHD service offering is simple: to accelerate early phase clinical manufacture and supply. In order to achieve this, PCI has taken three of its flagship services and combined them into a program that ensures a sponsor’s valuable API can get to Phase I clinical trials quicker, cheaper and more efficiently than via the traditional development route. Those three services are drug-in-capsule manufacture, using Xcelodose® micro-dosing technology; industry-leading clinical packaging services; and PCI’s bespoke clinical program management service, clinicalSMART™.

Service #1: Drug-in-Capsule Manufacture with Xcelodose® The traditional route through early clinical phase formulation development can be a complex and time-consuming process. Excipient compatibility studies, prototype development, and the associated stability studies themselves can take months to complete before the product can be delivered to the clinic. However, by providing drug in capsule (DIC) manufacturing services using Xcelodose® micro-dosing technology, sponsors can significantly reduce the time it takes to get the first-in-human dose to clinic.

Xcelodose® is a precision powder micro-dosing system that allows API to be filled directly into capsules and vials. This approach removes the need for development of a powder blend, as would be the case for a more traditional development processes. PCI operates both the Xcelodose® 120S and the 600S models, filling up to 120 and 600 capsules per hour respectively, making them ideal for clinical manufacture from early to later stage clinical programs. Additional investments in Xcelohood™ and Xceloprotect™ containment systems further enhances the safe processing of highly potent drug products at our manufacturing facility in the UK.

By eliminating the requirement for pre-formulation activities, excipient compatibility and associated stability studies, as well as simplification of method development processes, Xcelodose® enables products to be manufactured and delivered to clinic up to 6 months faster than the more traditional route. Dosing directly into capsules also helps to reduce the amount of API required, helping to eliminate wastage of often-valuable APIs which is particularly important at the early stages of proof of concept if API is in short supply.

Additionally, Xcelodose® is a fully programmable system, ensuring exceptional levels of accuracy, precision and consistency whilst minimizing wastage of drug substance. Capsules can be filled with API at dosage strengths ranging from 100 µg to 100 mg and beyond, and the weight of each capsule is recorded, allowing traceability of samples that meet GMP requirements. Enabling an optimised filling process compensates for variability in drug powder properties, simplifies method development, and improves data transfer, all of which contributes to greater efficiencies and speed to clinic and patient.

Service #2: Clinical Packaging Services Manufacturing DIC products containing highly potent APIs can be challenging, and not all CDMOs have the capability to package the same drug product safely on site. In 2022, PCI launched a new highly potent packaging facility (HPPF), located at the same site that hosts our Xcelodose® technology in the UK. Segregated rooms, dedicated HVAC systems, conditioned environments for packaging activities and dust extraction units to remove any airborne particulates from potent APIs ensures the highest level of operator safety and drug product integrity.

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