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Handling with Care: Aseptic Dip Coating for Osteoporosis Treatment

Kindeva Drug Delivery is a contract development and manufacturing organisation (CDMO) specialising in complex drug formulation and delivery. Seeking to scale its production of coated transdermal devices for a biologic API, the company enlisted systems integrator Keller Technology to design, build and integrate an aseptic dip coating system. Because the application demands extreme precision, the solution would depend on a Stäubli robot.

In the effort to bring life-changing medicines to a highly regulated market, pharmaceutical manufacturers must maintain a delicate balance between volume, repeatability and sterility. Drug delivery systems like those developed by Kindeva are the culmination of a series of carefully coordinated steps, where the API meets the patient. Preserving the sterility and efficacy of the product, and ultimately the safety of the patient is paramount.

With a nearly 175-year history, Kindeva has played a role in bringing hundreds of drug products to fruition. Among the Minnesotabased company’s innovations is a proprietary solid microstructured transdermal system (sMTS) platform. The microneedle-based device is highly patient-friendly, making it ideal for self-administering abaloparatide, a biologic that stimulates bone formation for postmenopausal women at high risk for bone fractures due to osteoporosis.

Since abaloparatide is a biologic API, it cannot be terminally sterilised. Therefore the processes involved in coating and packaging the abaloparatide-sMTS combination must take place entirely within an ISO Class 5 environment. In the lead-up to an NDA filing, Kindeva sought to reduce the product’s manufacturing cycle time. Only an automated system, capable of operating optimally within an aseptic isolator, could accomplish all of this.

The company turned to Keller Technology, a trusted partner with extensive experience in robotic applications for controlled environments in biotech and pharmaceuticals, including combination products like Kindeva’s sMTS. It was up to Keller, as the systems integrator, to identify a key component: a robot that meets all of the customer’s specifications.

The Right Robot for a Sensitive Environment

Stäubli Robotics was the clear choice to complete the triumvirate of expertise required for the sterile coating and packaging system. The company has a strong record of innovation in the automation of life science applications in hygienic and aseptic environments. Its full Stericlean range of robots is designed specifically for sterile use.

A variety of features enable Stäubli’s Stericlean robots to operate in a Grade A environment and maintain high performance under strict aseptic conditions: A fully enclosed structure with special seals keeps airborne particles to a minimum. The robot’s completely smooth surface, protected by a high-resistance coating, eliminates retention areas where antigens can proliferate. This design also enables the robot to withstand harsh VHP decontamination processes. All connections run through the base of the robot, safely outside the isolator.

Past experience was also a factor in choosing a robotics supplier. Keller had been integrating Stäubli robots successfully for years in various applications – including a Stericlean for a nearly identical sMTS application for Kindeva. They knew exactly what to expect: exceptional cleanliness, repeatability and accuracy. A Stericlean sixaxis robot, exceeding Kindeva’s requirements with an ISO Class 4 rating, was selected for integration into the system.

High Precision at Commercial Scale

The system Keller devised performs precision dip coating as well as primary packaging, all within an aseptic isolator. It begins when the sMTS devices are transferred into the isolator on trays, while the sterile liquid API is fed into a coating system, designed previously by Keller.