Director, Innovation, Strategic Projects, Bioproduction
Thermo Fisher Scientific
The bioproduction industry stands at a pivotal intersection, its trajectory shaped by the advancement of innovative modalities such as cell and gene therapies (CGT), multispecific biologics, and antibody-drug conjugates (ADCs). This evolution signals both promise and complexity, redefining how manufacturers are bringing life-changing medicines to patients.
Over the past year, scientific and technological progress has moved at a remarkable pace. Once considered experimental or confined to niche patient populations, advanced therapies are now reaching broader markets and transforming standards of care across numerous disease areas. This shift is evident in several ways: manufacturers are developing more new therapies than ever before, investors are focusing on manufacturing systems that can handle a range of different products, and regulators are reevaluating standards to ensure safety and effectiveness.
Yet, the rise of these sophisticated modalities demands new technical capabilities, coupled with the adoption of new manufacturing models, supply chain resilience, and global collaboration. Stakeholders from across the sector, including manufacturers, technology providers, regulators, and suppliers, are facing a landscape where adaptability is essential for success. As the bioproduction community navigates this new chapter, decisions made today will shape the future of innovation and patient access for years to come.
Rising methods reshape the landscape
Traditional monoclonal antibodies (mAbs) once dominated the biopharma pipeline and are a cornerstone of modern medicine. Today, the industry finds itself navigating an environment where over 60% of early-stage molecules fall into the category of novel mAbs or CGT, according to internal research. This decisive shift in innovation and capital allocation underscores the sector’s commitment to developing more targeted, efficacious therapies.
The rise of CGT in particular stands out as a defining trend. Since the first gene-modified cell therapy approval in 2017,1 the pipeline has grown exponentially, propelled by increasing commercial viability, clinical success, and continuous improvements in process technologies. Today, there are 46 approved cell and gene therapies within the United States.2
In addition, ADCs are generating considerable excitement and interest within the sector. Projections indicate the market for ADCs to triple over the next five years,3 largely fueled by advances in targeted oncology and combination regimens. These novel modalities offer the potential to transform patient outcomes, but also bring a new set of manufacturing and operational challenges that demand attention and agility across the sector.
Process complexity drives flexibility
The rise of new modalities brings added complexity to bioproduction. Unlike traditional biologics, cell and gene therapies and multispecific biologics often involve living cells or novel molecule designs, which creates new demands for raw materials, consumables, and process controls. Manufacturers must maintain consistent quality across batches, all while navigating a marketplace with few sources for specialized good manufacturing practice (GMP)-compliant materials and ongoing uncertainty in global supply chains.
Expanding production of these advanced therapies is also pushing conventional facility designs to their limits. The distinctive characteristics of living cells can place significant stress on bioreactor systems, making it necessary to rethink approaches to agitation, nutrient delivery, and ongoing monitoring. As upstream titers climb for traditional mAbs and for the new multispecific biologics, downstream infrastructure is under increasing pressure, driving the need for innovation in purification, formulation, and process intensification.
Digital transformation
To meet the industry’s evolving demands, bioproduction leaders are doubling down on flexible, modular manufacturing platforms. Single-use technologies and process intensification, for example, have become essential, enabling rapid pivots from benchtop research to commercial manufacturing. For small-volume biologics and personalized therapies, agility is not just beneficial; it’s essential.
Digital transformation has emerged as a cornerstone of the industry’s progress in recent years, too. The adoption of advanced analytics, process analytical technology (PAT), and artificial intelligence (AI) is moving out of the research lab and into the heart of manufacturing operations. Real-time monitoring and predictive analytics empower manufacturers to anticipate issues, optimize processes, and maintain regulatory compliance with unprecedented efficiency. All these drivers are helping organizations accelerate technology transfer, enhance quality assurance, and boost operational resilience.
The evolution of the supply chain mirrors this digital revolution. Transparency, quality, and real-time electronic data exchange now define the relationship between contract development and manufacturing organizations (CDMOs) and their partners. As biotech pipelines expand and outsourcing becomes more popular, the need for data-enabled, collaborative partnerships has never been greater.
Regulatory and geopolitical shifts
These advances are all taking place amid ongoing regulatory and geopolitical shifts across the world. Evolving global regulations are pushing manufacturers to strengthen risk management and invest in robust compliance systems.
Asia’s emergence as a global bioproduction innovation hub, as seen by the growing investment in CGT infrastructure investments across the region, is expanding the biopharma landscape. With significant investments in infrastructure and a growing pool of skilled talent, countries such as China and Singapore are positioning themselves at the forefront of global CGT and biologics manufacturing. The influx of capital and expertise into Asia-Pacific is supporting both local innovation and the diversification of the global supply chain. As a result, organizations are reevaluating their global strategies, seeking new partnerships, and exploring models for cross-border collaboration that support agility and resilience.
However, regulatory harmonization remains an ongoing challenge. The need to align standards for GMP-compliant materials, process validation, and quality control is more pressing than ever. As regulatory expectations continue to evolve, industry-wide collaboration becomes essential for ensuring both compliance and patient safety.
Sustainability takes center stage
Sustainability initiatives are continuing to drive transformative changes across the bioproduction industry, particularly in shaping decisions about facility design, packaging, and supply chain management.
Single-use technologies are continuing to help manufacturers make progress toward their sustainability goals and drive operational efficiency by reducing water and energy consumption, minimizing contamination risks, and enabling more flexible operations. In addition, single-use bioreactors have been shown to reduce the cost of consumables by 37%4 when compared to stainless steel.
Life cycle assessment (LCA) studies have helped validate the environmental advantages of single-use systems, including in the production of mAbs at commercial scale. Studies ranging in process volumes from 100 L to 2,000 L have shown that single-use systems result in lower water and energy consumption compared to conventional stainless-steel workflows. In fact, one LCA revealed that producing mAbs at a 2,000 L scale with single-use systems reduced water use by 87% and energy use by 29%5 when compared to fixed systems, mostly due to the elimination of the intensive cleaning and sterilization processes required by fixed stainless-steel equipment.
Ongoing investments in recycling programs also reflect the industry’s commitment to balancing innovation with environmental responsibility, an approach reinforced by evolving regulations, growing investor expectations, and strong advocacy from patients and the public.
Collaboration and adaptability
Collaboration has become a defining feature of the modern bioproduction landscape. Manufacturers, technology providers, regulatory bodies, and suppliers are increasingly joining forces to address complex challenges and accelerate innovation. These partnerships foster the sharing of expertise, streamline technology transfer, and enable the adoption of best practices across organizations.
Transparent data sharing and digital integration further strengthen these collaborative efforts, ensuring that information flows seamlessly throughout the value chain. By working closely together, stakeholders can drive continuous improvement, enhance product quality, and respond more rapidly to shifting market demands. Amid ongoing shifts across the globe, collective problem-solving and open communication are essential for advancing the industry and delivering next-generation therapies to patients.
The road ahead
As the industry turns the page to 2026, integration, standardization, and collaboration emerge as critical drivers of progress across the biopharma landscape. The seamless combination of flexible manufacturing platforms with advanced digital ecosystems will support operational agility and regulatory compliance.
At the same time, standardizing materials, methods, and data flows will help ensure consistency, reliability, and quality across the value chain. Collaborative innovation, including linking manufacturers, technology providers, regulators, and supply chain partners, will be essential for defining best practices, harmonizing standards, and overcoming operational and technological challenges.
The events of 2025 have showcased the industry’s agility, ingenuity, and openness to change. The rise of advanced modalities, the acceleration of digital transformation, and a sharpened focus on sustainability have reshaped expectations for what bioproduction can achieve. In the new year, bioproduction stands ready to advance further, fueled by a collective commitment to innovation and partnership. By working together, the sector can deliver on the promise of next-generation therapies, strengthen resilience and efficiency, and expand its positive impact on global health.
References
- Research C for DE and. FDA approves tisagenlecleucel for B-cell ALL and tocilizumab for cytokine release syndrome. FDA. Published online February 9, 2019. https://www.fda.gov/drugs/resources-information-approved-drugs/fda-approves-tisagenlecleucel-b-cell-all-and-tocilizumab-cytokine-release-syndrome.
- FDA. Approved Cellular and Gene Therapy Products. U.S. Food and Drug Administration. Published April 26, 2024. https://www.fda.gov/vaccines-blood-biologics/cellular-gene-therapy-products/approved-cellular-and-gene-therapy-products.
- Chen L, Bush B, Brochu M, King G. New Drug Modalities 2024. BCG Global. Published September 24, 2024. https://www.bcg.com/publications/2024/new-drug-modalities-report.
- Single-use vs. stainless steel: The biopharmaceutical manufacturing debate. https://www.thermofisher.com/document-connect/document-connect.html?url=https%3A%2F%2Fassets.thermofisher.com%2FTFS-Assets%2FBPD%2FReference-Materials%2Fsingle-use-vs-stainless-steel-white-paper.pdf&title=V2hpdGUgUGFwZXI6IFNpbmdsZS11c2UgdnMuIHN0YWlubGVzcyBzdGVlbC4gVGhlIGJpb3BoYXJtYWNldXRpY2FsIG1hbnVmYWN0dXJpbmcgZGViYXRlLg==.
- Single-Use Bioprocessing Systems. https://assets.fishersci.com/TFS-Assets/BPD/Reference-Materials/single-use-technologies-green-fact-sheet.pdf.
Moira Lynch is a director of innovation and strategic projects for bioproduction at
Thermo Fisher Scientific.
The post Bioproduction: Charting the Future of Advanced Bioproduction appeared first on GEN – Genetic Engineering and Biotechnology News.
