Ongoing Investment: The Key to Next-Gen Therapy Progress

Digital systems, automation, and flexibility are crucial for overcoming the hurdles associated with the development and manufacture of next-gen therapies, but ongoing investment is critical to ensure continued innovation in the sector.

There are still inherent complexities associated with the development and manufacture of next-gen therapies, and while advanced technologies have enabled progress, continued investment is needed. In an interview with The Pharma Navigator, Alexander Seyf, CEO Autolomous, highlights the complexities facing the development and manufacture of next-gen therapies, how advanced technologies are helping to address current limitations, where further development may be needed, why flexibility is important, and the role of CDMOs.

A Multifaceted Landscape

TPN: Could you give an overview of the specific challenges pertaining to the development and manufacture of next-generation therapies?

Seyf: Next-generation therapies are navigating a multifaceted landscape of regulatory, technical, and manufacturing complexities. The inherent scientific intricacies of these modalities, often involving living cells, gene editing, or novel delivery systems, fundamentally differ from traditional pharmaceuticals. Consequently, the regulatory pathway remains challenging, characterized by evolving guidelines and regional variations. Demonstrating robust traceability, control, and consistency across the entire lifecycle, from raw material sourcing to final product release, presents a significant hurdle, particularly following manufacturing changes where maintaining product comparability adds further complexity. Ensuring chain of identity and custody, upholding stringent quality and safety standards, and mitigating process variability are critical imperatives.

Manufacturing scalability remains a major impediment, stemming from the inherent complexities of these therapies and the limitations of existing infrastructure. Many early-stage workflows, developed for academic or research settings, rely heavily on manual processes, hindering standardization and large-scale production. This results in quality inconsistencies, variable yields, and protracted timelines. High GMP operational costs, scarcity of critical materials like viral vectors, and a shortage of skilled personnel further inflate expenses. The transition to commercial manufacturing often exposes weaknesses in process definition, documentation, and data continuity, impeding tech transfer and increasing the risk of delays and deviations. Addressing these manufacturing challenges is crucial for achieving efficient, reliable, and scalable production as more advanced therapies near commercialization.

Creating an Enhanced Infrastructure

TPN: How can advanced technologies help to overcome these development and manufacturing challenges?

Seyf: Addressing the current limitations in next-generation therapy development and manufacturing relies heavily on advanced technological solutions. In regulatory affairs, digital systems are driving standardized, transparent processes, simplifying data tracking, and ensuring robust traceability for streamlined compliance and GMP adherence. These tools provide enhanced lifecycle visibility, allowing organizations to maintain audit readiness and respond proactively to evolving regulations.

For manufacturing, automation and digitization are diminishing the need for manual steps and specialized personnel, leading to improved scalability and consistent batch quality. Real-time data capture within electronic batch records and advanced reporting and analytics empower optimized production, early deviation flagging, and faster, more informed decisions. Furthermore, technologies such as closed-system manufacturing and modular facilities are increasing capacity, minimizing variability, and accelerating global technology transfer. Ultimately, these innovations are creating a more efficient, scalable, and sustainable infrastructure for delivering transformative therapies to patients.

Continued Innovation and Deeper Collaboration Needed

TPN: Are there any potential areas where advanced technologies are not yet suitable for use or where further development is needed?

Seyf: While advanced technologies are accelerating progress in the development and manufacture of next-generation therapies, several areas still require further refinement before they can deliver consistent, large-scale impact.

Real-time in-process analytics, for example, remain limited in their ability to monitor complex biological variables with the precision needed for true real-time release or continuous manufacturing. AI and machine learning are also promising but often constrained by fragmented, low-volume datasets, particularly in early clinical phases, where batch numbers are small and data quality varies. Without stronger data foundations, these tools cannot reliably support decision-making or process optimization.

Modular and point-of-care manufacturing introduce further complexity. Regulatory frameworks and quality systems are still adapting to decentralized models, and while digital platforms that connect manufacturing, quality, and supply chain systems do exist, inconsistent standards and uneven adoption can limit their effectiveness.

To unlock the full potential of these technologies, continued innovation and deeper collaboration across the ecosystem will be essential.

Benefits of Adaptability

TPN: Why is flexibility particularly important for the increasingly complex development pipelines? How can advanced technologies help with this aspect?

Seyf: Flexibility is crucial in next-generation therapy development as pipelines become more complex and varied. Different modalities, evolving processes, and changing product requirements demand systems that can adapt quickly without compromising quality or timelines. Rigid infrastructure and manual workflows struggle to keep pace with these shifts in an ever-evolving sector, often leading to delays and inefficiencies.

Advanced technologies enable greater flexibility by allowing teams to adjust workflows, scale processes, and onboard new products with minimal disruption. Configurable digital platforms, modular manufacturing systems, and real-time analytics support faster decision-making and smoother tech transfer. This adaptability helps organizations manage complexity more efficiently and respond to change with greater speed and control.

Ongoing Investment is Key

TPN: How are CDMOs utilizing advanced technologies to drive forward innovation in next-gen therapies in your opinion? Does more need to be done?

Seyf: CDMOs are playing an increasingly important role in driving innovation in next-generation therapies, not just by scaling production, but by actively enabling more advanced science. Many are adopting automation, AI, and digital platforms that help reduce variability, improve yields, and speed up development timelines. This means they’re not only improving efficiency, but actually helping bring more consistent, scalable, and even faster therapies to patients. For example, automated manufacturing platforms and AI-driven process optimization are making it easier to produce complex cell therapies and adapt to newer formats like allogeneic or gene-edited products. At the same time, digital systems are improving tech transfer and quality control, which are essential for innovation at scale. Ultimately, digital tools allow CDMOs to cultivate transparency and trust with their clients, a foundational element for enabling innovation.

However, more progress is needed. Adoption across the sector remains uneven, with many smaller or traditional CDMOs still relying on manual, paper-based systems that limit scalability and visibility. In a fast-moving field where product requirements and regulatory expectations evolve rapidly, the ability to adapt and digitize is essential. Ongoing investment in digital talent, integrated platforms, and flexible infrastructure will be key. Just as importantly, greater data sharing and collaboration across CDMOs, therapy developers, and technology providers can accelerate innovation, reduce duplication, and support the development of shared standards that benefit the entire industry and, ultimately, the patients

Photo by Akhilesh Sharma on Unsplash.