Allele offers cGMP iPSC manufacturing capabilities to support cell therapy programs from clinical preparation through scalable production. Our manufacturing platform is built on more than a decade of continuous cGMP operations and ISO7-certified cleanroom infrastructure, with workflows specifically optimized for iPSC-based products.
Manufacturing activities are conducted under a comprehensive Quality Management System (QMS) that governs facilities, equipment, materials, personnel training, documentation, and change control. Our services support both programs developed within Allele and those transferred from external sites, enabling reliable manufacturing execution across different program origins.
Core manufacturing activities include process installation and qualification, personnel training and qualification, routine production operations, and downstream handling steps such as finishing, packaging, labeling, storage, and distribution. All manufacturing runs follow defined protocols and Master Batch Records, with quality control testing applied throughout production and formal quality assurance review prior to release.
Manufacturing readiness is maintained through facility and equipment qualification, aseptic qualification, and ongoing preventive maintenance. Critical process parameters and quality attributes are controlled to ensure consistency and reproducibility. Our cGMP iPSC manufacturing platform is designed to integrate smoothly with upstream development and downstream clinical and commercial needs, supporting program continuity and scalability.
