PDA 2025: Optimizing Biomanufacturing and Automation for Quality and Scalability

Editor's note: this story was originally published on BioPharmInternational.com.

A slew of multifaceted challenges are facing the biopharmaceutical industry's advanced cell therapy sector, including product quality, regulatory compliance, and manufacturing scalability. Traditional autologous cell therapy workflows, often reliant on manual processing, inherently introduce such risks as contamination, human error, and data integrity vulnerabilities, all of which directly impact patient safety and therapeutic efficacy (1).

A persistent misconception within the biopharma industry suggests that advancing quality and compliance invariably necessitates increased costs or reduced output. However, as Ossama Eissa, chief operating officer at Cellares, said during his presentation, “Upgraded Facilities to Assure Quality and Compliance,” at the Parenteral Drug Association (PDA) Regulatory Conference 2025, this is a myth (1). Citing FDA’s aseptic processing guidance, Eissa quoted, "Any intervention or stoppage during aseptic processing can increase the risk of contamination" (2).

He further elaborated on this principle, stating, "the more intervention you have the more risk you might incorporate, and the more controls you need to [exert] to make sure that you reduce those risks." This perspective advocates for a paradigm shift involving strategic investment in integrated automation, which can simultaneously elevate quality and compliance standards while enhancing productivity and cost-efficiency for biopharma manufacturers.

How does automating cell therapy manufacturing provide aseptic assurance and scalability?

The core of biopharma manufacturing, particularly for autologous cell therapies, involves complex, multi-step processes, such as enrichment, selection, activation, transfection, expansion, and formulation, Eissa enumerated in his talk. These traditionally manual operations necessitate frequent injections, sterile welds, material transfers, and exhaustive documentation, each presenting a potential point of failure for contamination or data integrity.

Taking an automated approach can address these challenges, as with Cellares’ Cell Shuttle platform technology. Eissa pointed out that this platform employs a single-use consumable cartridge that integrates all essential unit operations, allowing patient material to remain within a closed system from initial loading until harvest, significantly reducing manual intervention and associated risks. The cartridge’s passive components are activated by a bioprocessing system, which provides electric motors, load cells, and peristaltic pumps. Furthermore, key modules within the cartridge include a centrifugal elutriation system for cell enrichment, magnetic selection and electroporation flow cells, a perfusion-enabled bioreactor system, and formulation containers.

A fluidic bus system facilitates software-defined transfer of cells and reagents between modules, offering workflow flexibility within a single cartridge design. By processing up to 16 cartridges in parallel within a compact footprint, this closed, automated system significantly improves sterility assurance and quality by minimizing manual movements and aseptic risks, while scaling manufacturing capacity from tens to hundreds of patients annually, Eissa explained in his talk. The benefit to biomanufacturers, particularly in cell therapy, is that this closed system directly translates to reduced contamination rates, higher product consistency, and the ability to meet increasing patient demand, Eissa said.

How do integrated QC solutions benefit data integrity and throughput?

Quality control (QC) in cell therapy manufacturing typically constitutes a substantial operational team, often exceeding manufacturing personnel in autologous settings due to the individualized nature of patient batches. Conventional QC processes involve extensive manual handling for scheduling, reagent and sample preparation, assay execution, and data verification, all of which are susceptible to variability and human error, Eissa emphasized.

Automated QC platforms (e.g., Cell Q, Cellares) integrate commercial off-the-shelf instruments—including cell counters, flow cytometers, centrifuges, plate readers, incubators, and polymerase chain reaction systems—with a robotic liquid plate handler. As Eissa explained, this automation streamlines the majority of in-process and release testing assays, from sample loading to automated data upload into laboratory information management systems. The benefits to biomanufacturers are substantial and include automated generation of electronic batch records for thousands of doses annually, accelerated analytical method transfer, improved assay robustness, reduced manual labor, and significantly higher data quality and consistency. This integration enhances regulatory compliance and provides a reliable audit trail, which is critical for product release and patient safety, he added.

What role does peripheral system automation play in the push for facility-wide operational excellence?

Beyond core manufacturing and QC, automation in peripheral facility systems further contributes to overall quality, compliance, and cost efficiency. Automated warehousing systems, similar to those found in other high-volume industries, utilize smart storage logic and barcode scanning for automated material loading and retrieval. This approach reduces picking errors and minimizes inventory discrepancies and wrong shipments, while automatically updating inventory systems via enterprise resource planning integration, Eissa highlighted.

By storing barcoded materials in standardized boxes and automating retrieval through a human-machine interface, these systems enhance operator safety, reduce the likelihood of selecting incorrect materials, and improve traceability and security of valuable patient products. Collectively, these peripheral system upgrades reduce variability, mitigate manipulation risks, improve data integrity, and minimize aseptic interventions across the entire facility, thereby fundamentally assuring product quality and compliance while simultaneously increasing productivity and reducing operational expenditures, Eissa concluded.

The PDA Regulatory Conference 2025 was held on Sept. 8–10 in Washington, D.C.

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References

1. Eissa, O. Upgraded Facilities to Assure Quality and Compliance. Presentation at PDA Regulatory Conference 2025, Washington, DC., Sept 8–10, 2025. chrome-extension://efaidnbmnnnibpcajpcglclefindmkaj/https://80a7ba3d04f8b71aa576-301909dc4570c350a1649a6d39e3ef3b.ssl.cf1.rackcdn.com//3180113-2786354-002.pdf
2. FDA. Guidance for Industry, Sterile Drug Products Produced by Aseptic Processing—Current Good Manufacturing Practice (CDER, CBER, October 2004).