Dear colleagues,

The field of regenerative medicine is undergoing a transformative shift, moving from pioneering proof-ofconcept studies to the critical stage of scalable and robust clinical application. While advanced cell-based therapies hold unprecedented potential for treating a wide range of diseases, their successful translation from the laboratory bench to the patient bedside is hampered by significant bottlenecks in manufacturing, quality control, and delivery.

This special issue, “Next-Generation Biomanufacturing for Cell and Gene Therapies: From Preclinical Promise to Clinical Reality,” aims to address this pivotal gap. We seek to compile high-quality research and review articles that focus on the engineering and operational challenges of producing these complex living medicines. The scope extends beyond initial engineering strategies to encompass the entire product lifecycle, including scalable expansion systems, novel bioreactor technologies, integrated process analytics, and innovative solutions for cryopreservation and supply chain logistics.

By highlighting advances in automation, standardization, and quality-by-design principles, this issue will serve as a critical resource for researchers and industry professionals dedicated to making next-generation therapies more accessible, affordable, and effective for a global patient population

The scope is structured around several key themes:

Scalable Bioprocess Development: Contributions on novel bioreactor systems (e.g., hollow-fiber, fixedbed), microcarrier-based expansion, intensified processes (perfusion/continuous manufacturing), and strategies for scaling up allogeneic (off-the-shelf) and scaling out autologous (patient-specific) therapies.

Advanced Analytics and Quality Control: Research on implementing Process Analytical Technology (PAT), developing rapid and potent assays, utilizing AI/ML for real-time process control, and establishing robust release criteria for complex cell products.

Vector Manufacturing and Delivery: Studies addressing the bottleneck of viral and non-viral vector production, purification, and titration, as well as novel methods for the efficient and safe in vivo delivery of gene therapies.

Supply Chain and Logistics Engineering: Investigations into optimized cryopreservation protocols, cold chain management, chain of identity tracking, and regulatory frameworks that ensure product integrity from the factory to the patient.

Regulatory and Quality-by-Design (QbD) Frameworks: Reviews and perspectives on navigating the regulatory landscape for Advanced Therapy Medicinal Products (ATMPs), and applying QbD principles to ensure consistent product quality and facilitate regulatory approval.

Envisioned Article Types

To capture a comprehensive range of insights, we invite submissions in the following formats:

Original Research Articles: Full-length reports on novel experimental findings, data-driven process optimizations, and technological innovations in the biomanufacturing field.

Comprehensive Reviews: In-depth surveys of the current state-of-the-art in a specific area, synthesizing and critically evaluating existing literature to identify future trends and challenges. (By invitation or prior consultation with guest editors).

Short Communications: Concise articles reporting on preliminary but highly significant results, new methodologies, or novel technological platforms.

Perspectives and Opinions: Forward-looking articles that present a personal viewpoint on emerging trends, regulatory pathways, or ethical considerations, intended to stimulate discussion.

Case Studies: Detailed reports on the development and implementation of a specific process or technology within an industrial or academic setting, highlighting practical solutions and lessons learned.

Suggested Keywords:
Bioprocess Engineering
Scalable Manufacturing
Gene Therapy Vectors
Quality by Design (QbD)
Autologous & Allogeneic Therapies
Process Analytical Technology (PAT)
Cryopreservation & Logistics
Regulatory Science for ATMPs