A major biopharmaceutical company has filed a First-in-Human (FIH) clinical trial application with drug product manufactured using the PAK BioSolutions system. The milestone demonstrates the platform's performance in GMP clinical manufacturing environments.
Drug product manufactured using the PAK BioSolutions purification system supports clinical trial submission, demonstrating real-world performance in GMP clinical manufacturing.
VIENNA, Va., July 1, 2026 /PRNewswire-PRWeb/ -- PAK BioSolutions today announced that a major biopharmaceutical company has successfully filed a First-in-Human (FIH) clinical trial application with drug product manufactured using the PAK BioSolutions system.
The PAK platform was utilized in GMP clinical manufacturing operations, supporting production of drug product used in the clinical filing. The outcome demonstrates the system's ability to operate within regulated manufacturing environments where consistency, control, and compliance are required.
The successful FIH filing represents a meaningful validation point for the PAK System in clinical-stage manufacturing. Use of the platform in GMP operations aligned with a clinical submission highlights its capability to support drug development programs as they advance toward human trials.
"Supporting a First-in-Human filing is an important step in demonstrating the readiness of the PAK System for GMP clinical manufacturing," said Joanna Pezzini, CEO at PAK BioSolutions. "This milestone reflects the ability of the platform to meet specifications and deliver reliable performance in a highly regulated environment."
The use of the PAK System by a major biopharmaceutical company reflects increasing industry interest in continuous manufacturing approaches that can increase productivity and reduce manufacturing costs.
The PAK System is designed to operate multiple steps simultaneously, including:
- Chromatography
- Virus Inactivation
- Filtration
- UFDF
Its continuous manufacturing approach enables over 4X faster production or 4X greater output from an existing facility footprint. New facilities can be built with a 60% footprint reduction and 50% cost reduction.
Organizations preparing for clinical manufacturing are increasingly evaluating platforms based on their ability to reduce costs while maintaining process consistency with scale up. Demonstrated use of the PAK systems in a clinical filing provides an important reference point for those assessments.
For additional information about the PAK System for GMP clinical manufacturing, visit PAKBioSolutions.com.
About PAK BioSolutions
PAK BioSolutions is a bioprocessing technology company advancing continuous manufacturing solutions for biopharmaceutical production. The PAK System enables GMP-grade, scalable, and efficient drug manufacturing across process development, clinical, and commercial applications.
Media Contact
Gregory Isaacs, PAK BioSolutions, 1 (703) 849-4900, [email protected], https://pakbiosolutions.com/
SOURCE PAK BioSolutions
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