Revolutionizing ADC Manufacturing: How Single-Use Technologies Are Reshaping Biopharma Efficiency and Safety

November 6, 2025

Contributed Commentary by Damla Boyer, MilliporeSigma 

November 6, 2025 | Antibody-drug conjugates (ADCs) are among the most promising and complex therapeutics in modern oncology. By combining the targeted precision of monoclonal antibodies with potent payloads, ADCs offer a wider therapeutic window and new hope for difficult-to-treat cancers. While cytotoxics remain the most established class of payloads, the field is rapidly diversifying to include immunostimulatory agents, radioconjugates, and other novel mechanisms, broadening the potential impact of ADCs across oncology and beyond. 

The global ADC market is growing at an extraordinary pace, valued at $10 billion based on 2023 market data and projected to exceed $58 billion by 2030. Today, more than 400 ADCs are in development worldwide, with over 200 in clinical trials, driven by a surge in clinical candidates and rising cancer prevalence. 

Yet, this promise comes with complexity. Multi-step conjugations, long processing times, highly potent raw materials, and stringent quality requirements pose significant manufacturing challenges. Any innovation that streamlines ADC production, while safeguarding operators and preserving product integrity and quality, can accelerate the delivery of life-saving therapies to patients. 

The Shift to Single-Use Systems 

Traditionally, ADC production relied on glass or stainless-steel mixers for the conjugation reaction. While robust, these systems demand rigorous cleaning, lengthy changeovers, and validation procedures, each introducing downtime, cost, and contamination risk. In contrast, single-use systems (SUS) are replacing multi-use process equipment, providing disposable, pre-sterilized flow paths and vessels that eliminate the need for cleaning and reduce contamination risk. 

The adoption of SUS in monoclonal antibody production is now well-established, but its application to full ADC manufacturing, from development through GMP scale, is still emerging. The benefits are compelling: 

  • Safety: Minimizes operator exposure to highly potent APIs. 
  • Contamination Control: Eliminates cleaning and associated cross-contamination risk. 
  • Speed: Reduces downtime between batches. 
  • Confidential: Not for Public Consumption or Distribution 
  • Flexibility: Enables faster changeovers in multi-product facilities. 
  • Sustainability: Cuts water and energy usage by eliminating clean-in-place cycles. 

However, concerns remain, from solvent compatibility along with extractables and leachables (E&L) to mixing performance and scalability. At higher volumes, single-use technologies can face practical limitations compared to established stainless-steel systems. Separately, explosion protection (XP) and ATEX (Atmosphères Explosibles – a mandatory European Union directive) safety requirements add further complexity at scale. Addressing these challenges, while building on the flexibility and efficiency of single-use systems, will be essential for broader industry adoption. 

Strategic Implications for CDMOs and Biopharma Companies 

The rise of single-use technologies in ADCs manufacturing presents several strategic implications for both CDMOs and biopharma companies, particularly as ADCs emerge as a leading modality in oncology and precision medicine. By leveraging molecular, single-use setups, CDMOs can avoid the high capital costs associated with stainless-steel facilities. Below are some key strategic considerations shaping the industry: 

  • Strategic Partnerships: CDMOs with advanced single-use ADC capabilities are increasingly attractive targets for partnerships and acquisitions, as biopharma companies seek specialized, flexible manufacturing solutions. 
  • Capital Efficiency: SUS reduce the need for costly infrastructure investments, allowing CDMOs to scale operations more economically and respond quickly to market demands. 
  • Scalability: SUS support modular production, enabling biopharma firms to scale from small clinical batches to large commercial volumes without renegotiating contracts. 
  • Sustainability Impact: Single-use technologies can lower water and energy consumption, aligning with ESG goals and enhancing the environmental profile of ADC manufacturing operations. 

Looking Ahead: The Future of Bioprocessing 

The promise of single-use systems extends well beyond ADCs. As these platforms integrate with digital tools, automation, and advanced analytics, manufacturers gain unprecedented visibility into process performance, from mixing dynamics to real-time quality monitoring, while maintaining the inherent flexibility and efficiency of disposable systems. Stainless-steel platforms are also evolving, with continuous processing and automated monitoring increasingly possible, highlighting that innovation is occurring across technologies. Emerging trends suggest broader adoption across modalities, including bispecific ADCs, 

Fabs, monoclonal antibodies, and cell therapies. Regulatory agencies are also increasingly familiar with SUS validation pathways, making it easier for companies to justify adoption without delaying clinical timelines. 

Sustainability considerations will further accelerate the shift: eliminating thousands of liters of cleaning water per batch, along with the associated energy for heating and cooling, aligns with corporate Environmental, Social and Governance (ESG) goals and customer expectations. 

Why Now Is the Time to Invest in Single-Use Innovation 

As ADC pipelines expand and timelines tighten, the industry must rethink traditional manufacturing models. Single-use technologies are no longer just operational conveniences, they are strategic enablers of speed, safety, and scalability. 

The evidence is clear: with proper design, testing, and risk mitigation, complete single-use ADC manufacturing is not only feasible but advantageous at GMP scale. For CDMOs, the ability to rapidly onboard new projects without costly facility retrofits can be a competitive differentiator. For biopharma companies, it’s an opportunity to accelerate innovation while protecting operators, reducing environmental impact, and ensuring consistent product quality. 

The question is no longer if single-use systems can handle the complexity of ADC production, it’s how quickly the industry can adopt them to bring critical therapies to patients faster. 

 

Damla Boyer is the Global Modality Manager for Antibody-Drug Conjugates (ADCs) and novel monoclonal antibodies at Merck, where she leads strategic initiatives to expand market presence, foster cross-functional collaboration, and accelerate customer adoption of cutting-edge bioprocessing solutions. With more than a decade of experience spanning research and development, product management and marketing, she blends deep scientific expertise with strong business acumen to drive growth and innovation in the life sciences sector. She can be reached at damla.boyer@milliporesigma.com.