Benchmarking Quality Systems in Cell and Gene Therapy: Insights from Yelena Ionova

In part two of a recent interview with BioPharm International®, Dr. Yelena Ionova, senior manager, Data Strategy and Analytics, of Redica Systems, explains how cell and gene therapy manufacturers can use inspection benchmarking, contamination control strategies, and data-driven regulatory intelligence to identify quality risks, strengthen compliance programs, and prepare for increasing regulatory scrutiny. She presented at the 2026 AAPS National Biotechnology Conference, which is running May 11–14 in San Diego, Calif. In her conference presentation, “Compliance in Cell and Gene Therapy Manufacturing: Anticipating Global Trends,” Dr. Ionova discussed how increased regulatory scrutiny across the cell and gene therapy (CGT) sector is driving manufacturers to take a more proactive and data-driven approach to inspection readiness and quality oversight. In this interview, Ionova focused on emerging inspection trends and benchmarking strategies and discussed how companies can better prepare for evolving regulatory expectations by leveraging industry-wide inspection intelligence.

Many CGT manufacturers still operate with limited visibility into the types of deficiencies being cited across peer facilities. By aggregating inspection findings and Form 483 observations across the industry, organizations can identify recurring risk areas that may otherwise go unnoticed internally.

“The short answer is, you want to benchmark before the inspector arrives,” Ionova said. “Most cell and gene therapy manufacturers today have limited visibility into what’s happening at peer facilities.”

According to Ionova, benchmarking data revealed that sterile environment controls are cited at significantly higher rates in CGT manufacturing compared with the broader pharmaceutical industry. Production training gaps and contamination control issues also remain among the most common observations during inspections.

These insights can help manufacturers prioritize mock inspections, internal audits, and corrective and preventive action (CAPA) programs. Rather than treating regulatory intelligence as a periodic reporting exercise, she encouraged companies to adopt continuous monitoring systems capable of tracking inspection trends and evolving global guidance documents in real time.

Ionova also highlighted the increasing pace of regulatory activity in the sector, noting that inspection volume has grown dramatically in recent years alongside the expansion of approved CGT products worldwide.

As regulators continue increasing oversight both before and after product approval, Ionova said companies that invest early in data-driven quality systems and continuous inspection readiness will be better positioned to bring therapies to patients more efficiently.

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About the speaker

Yelena Ionova, Pharm.D., Sr Manager, Data Strategy and Analytics, Redica Systems

Yelena Ionova, Pharm.D., is a regulatory data strategy leader with expertise in quality compliance analytics, regulatory intelligence, and post-market surveillance. She serves as Senior Manager of Data Strategy & Analytics at Redica Systems, leading initiatives that support quality risk management for pharmaceutical and medical device companies. Previously, she worked as a regulatory consultant, postdoctoral scholar at UCSF, and fellow at the U.S. Pharmacopeia Quality Institute. Ionova earned her Pharm.D. from UCSF and dual bachelor’s degrees from UC Berkeley. She is also a Certified Quality Science Professional (CQSP).