FDA Manufacturing PreCheck Pilot Program Selects 7 Companies Including Cellares to Streamline and Expedite Cell Therapy Manufacturing Processes

July 5, 2026

RegMedNet UK

Overview

The FDA has selected seven companies, including Cellares Corp, FUJIFILM Biotechnologies, and Kriya Therapeutics, for its “Manufacturing PreCheck Pilot Program,” designed to streamline cell and gene therapy manufacturing processes and accelerate market access. This program aims to identify companies with innovative manufacturing technologies and quality systems early, enhancing dialogue with regulators to facilitate a smoother approval process. These selected companies are expected to play a crucial role in resolving manufacturing challenges for the commercialization of cell therapies.

In Depth

Key Findings

The U.S. Food and Drug Administration (FDA) has selected seven biotechnology companies for its groundbreaking “Manufacturing PreCheck Pilot Program,” an initiative designed to streamline the manufacturing processes for cell and gene therapy products and accelerate patient access. Among the chosen firms are Cellares Corp, known for its automated cell therapy platforms; FUJIFILM Biotechnologies, a leading CDMO; and Kriya Therapeutics, a company actively developing gene therapies. This program’s objective is to evaluate the innovative manufacturing technologies and quality management systems of these companies early, thereby facilitating the approval process through collaborative dialogue with regulatory authorities.

Technical / Clinical Details

The FDA’s Manufacturing PreCheck Pilot Program is a crucial initiative to address the complexities and bottlenecks inherent in cell and gene therapy manufacturing. Selected companies will undergo pre-submission consultations and reviews with the FDA concerning their manufacturing facilities, processes, and quality control systems. This proactive engagement is expected to minimize manufacturing-related delays that can occur during product commercialization applications, thereby shortening the path to approval. For instance, Cellares Corp aims to significantly improve productivity, consistency, and quality with its fully automated and closed cell therapy manufacturing platform, compared to traditional manual processes. CDMOs like FUJIFILM Biotechnologies provide scalable solutions to meet diverse client manufacturing needs, while Kriya Therapeutics is deploying efficient manufacturing strategies to support its gene therapy pipeline. This program is particularly vital for advanced therapeutics, where manufacturing scale-up, quality assurance, and regulatory compliance are highly demanding.

Background & Context

The cell and gene therapy sector is generating groundbreaking treatments for severe diseases, but its commercialization has been hindered by complex and costly manufacturing processes, stringent quality control requirements, and limited manufacturing capacity. The FDA’s Manufacturing PreCheck program acknowledges these challenges and represents a regulatory effort to actively collaborate with the industry, providing a framework to deliver innovative therapies to patients more swiftly and safely. As evidenced by the surge in Regenerative Medicine Advanced Therapy (RMAT) designations since 2024, the maturation of the cell and gene therapy pipeline increases the importance of early engagement with manufacturing and quality regulatory requirements. This pilot program plays a critical role in strengthening coordination between regulators and manufacturers and bolstering the overall manufacturing ecosystem of the industry.

Strategic Significance & Outlook

The success of the Manufacturing PreCheck Pilot Program could significantly accelerate the commercialization process for cell and gene therapy products. Selected companies will be able to optimize their manufacturing technologies and quality systems through close collaboration with the FDA, thereby facilitating future product approvals. This not only improves patient access to therapies but also enhances the market competitiveness of these companies. The insights gained from this program are expected to influence regulatory guidelines and best practices across the entire cell and gene therapy sector, contributing to an industry-wide improvement in manufacturing capabilities and efficiency. This will pave the way for advanced cell therapies to reach a broader patient population.

Source: https://www.regmednet.com/cell-therapy-weekly-association-launches-in-europe/

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