Manufacturing and supply chain resilience has moved to the forefront of strategic planning across the life sciences industry as advanced therapies place unprecedented strain on existing production models. Cell therapies, gene therapies, mRNA platforms and increasingly complex biologics are exposing structural weaknesses in global manufacturing capacity, logistics and regulatory readiness. What was once viewed as a back end operational concern is now widely recognised as a competitive differentiator that can determine which programmes reach patients and which stall before commercialisation.
This shift has been accelerated by the rapid maturation of advanced therapeutic modalities. Autologous and allogeneic cell therapies require tightly controlled, time sensitive production workflows. Gene therapies rely on specialised viral vector manufacturing that remains capacity constrained worldwide. mRNA platforms, proven at scale during the COVID 19 pandemic, continue to evolve into more complex formulations that demand new approaches to quality control and cold chain logistics. Together, these modalities are forcing the industry to rethink how medicines are made, moved and regulated.
From Centralised Production to Localised Manufacturing
One of the most visible trends reshaping advanced therapy manufacturing is the move away from heavily centralised production towards more localised or regional manufacturing models. Globalised supply chains delivered efficiency and scale for traditional biologics, but they have proven fragile in the face of geopolitical disruption, trade restrictions and public health emergencies.
Advanced therapies magnify these vulnerabilities. For personalised cell therapies in particular, long distance shipping of patient material introduces risk at every step. Manufacturing delays, temperature excursions or customs bottlenecks can compromise an entire treatment. As a result, many developers are now exploring distributed manufacturing models that bring production closer to the patient or clinical site.
Industry analysts note that regional manufacturing hubs can reduce turnaround times, improve chain of identity control and simplify regulatory oversight. However, localisation also introduces new challenges, including duplication of infrastructure, workforce training and harmonisation of quality systems across sites. The success of these models will depend on advances in automation and digital manufacturing platforms that allow consistent production at smaller scale.
Automation as the Backbone of Scale and Consistency
Automation has emerged as a critical enabler of resilience for advanced therapy manufacturing. Manual processes that were acceptable during early clinical development are increasingly untenable as programmes move toward late stage trials and commercial supply. Automated closed systems reduce contamination risk, improve reproducibility and lower dependence on scarce specialist labour.
In cell therapy manufacturing, automation is helping address one of the sector’s most persistent constraints: skilled workforce availability. Fully or semi automated platforms can standardise complex steps such as cell isolation, expansion and formulation, allowing companies to scale without proportionally increasing headcount. This approach also supports technology transfer between sites, a key requirement for both localisation and partnership with contract manufacturers.
Regulators have signalled growing comfort with automated and digitally enabled manufacturing systems when supported by robust validation and data integrity frameworks. Guidance from agencies such as the US Food and Drug Administration’s advanced manufacturing initiatives reflects increasing regulatory recognition that modern manufacturing technologies can improve product quality rather than increase risk.
CDMO Capacity Remains a Bottleneck
Despite investment across the sector, capacity at contract development and manufacturing organisations continues to lag demand for advanced therapies. Viral vector production remains particularly constrained, with limited availability of high quality plasmids, specialised cell lines and GMP grade facilities. Developers frequently report long lead times and competition for slots, even for late stage assets.
Large CDMOs have responded with significant capital investment, expanding facilities dedicated to cell and gene therapy manufacturing and integrating end to end services from process development to commercial supply. At the same time, a new generation of specialised CDMOs has emerged, focused exclusively on advanced modalities rather than traditional biologics.
According to recent analysis published by BioPharma Dive, the ability to secure reliable manufacturing partnerships is increasingly influencing clinical development timelines and investment decisions, particularly for companies advancing cell and gene therapy programmes.
Regulatory Readiness and Harmonisation Challenges
Regulatory frameworks have not stood still as advanced therapies have progressed, but alignment across regions remains uneven. Differences in expectations around comparability, process changes and post approval manufacturing modifications can complicate global supply strategies.
For advanced therapies, manufacturing changes are often inevitable as processes mature. Scaling up viral vector yields or introducing automation into a cell therapy workflow can trigger regulatory scrutiny if not managed carefully. Developers must balance the need for process optimisation with the requirement to demonstrate product consistency and clinical relevance.
Regulators have acknowledged these challenges. Initiatives from bodies such as the European Medicines Agency and international harmonisation efforts signal growing engagement with advanced manufacturing models, although regulatory readiness remains a critical factor in supply chain resilience.
Lessons from the Pandemic and Beyond
The COVID 19 pandemic provided a real world stress test for biopharmaceutical manufacturing and supply chains. While mRNA vaccines demonstrated unprecedented speed and scalability, they also highlighted dependencies on raw materials, lipid components and cold chain infrastructure.
Those lessons are now being applied beyond vaccines. Companies are investing in dual sourcing strategies, strategic stockpiling of critical inputs and closer collaboration with suppliers. Digital supply chain visibility tools are also gaining traction, enabling real time monitoring of materials, inventory and logistics across complex networks.
A recent report from McKinsey & Company highlights that manufacturers who invest in resilience alongside efficiency are better positioned to withstand disruption while maintaining speed to market, a balance that is particularly critical for advanced therapies.
Manufacturing as a Competitive Advantage
Perhaps the most significant shift is cultural rather than technical. Manufacturing is no longer viewed as a downstream activity that follows scientific success. Instead, it is increasingly integrated into early development strategy. Decisions around modality choice, target indication and clinical design are being made with manufacturing feasibility in mind.
Investors are paying closer attention to manufacturing readiness when evaluating advanced therapy companies. Assets supported by scalable, regulator ready processes are perceived as lower risk, even at earlier stages of development. Conversely, promising science without a credible manufacturing plan can struggle to attract sustained funding.
Outlook for the Sector
Looking ahead, manufacturing and supply chain resilience will remain a defining theme for advanced therapies. Continued investment in automation, regional capacity and regulatory engagement is expected, alongside deeper partnerships between developers, CDMOs and technology providers.
The industry’s ability to deliver on the promise of cell, gene and mRNA therapies at scale will depend not only on scientific breakthroughs, but on the robustness of the systems that support them. In this environment, manufacturing excellence is becoming a source of differentiation that can accelerate patient access, strengthen commercial outcomes and shape the future of advanced medicine.
