The global cell therapy bioprocessing market is projected to grow at a CAGR of 13.01% between 2024 to 2032, as per Inkwood Research. Cell therapy involves utilizing human cells to treat diseases and repair damaged tissues. As cell therapies continue to show promise for treating cancer, neurological conditions, and musculoskeletal disorders, optimizing bioprocessing techniques is crucial forscale-up and affordability.
Rapid progress in cell biology, gene editing tools like CRISPR, and single-cell analysis are opening new possibilities. Furthermore, automation, Artificial Intelligence (AI), and advanced analytical methods are also transforming cell therapy manufacturing.
Cell therapy bioprocessing is complex, with living cells highly sensitive to environmental fluctuations. Maintaining aseptic conditions and consistent quality at scale is challenging. In this regard, companies are implementing innovative techniques to enhance process outputs.
Cell Therapy Bioprocessing Market | Driving Efficiencies Through Optimized Processes
Cell therapy bioprocessing is complex, with living cells highly sensitive to environmental fluctuations. Maintaining aseptic conditions and consistent quality at scale is challenging. Companies are implementing innovative techniques to enhance process outputs.
As per a senior executive at Miltenyi Biotec, adopting the MACS GMP Prodigy for automated cell separation reduced processing time from 12 hours to just 90 minutes, allowing us to manufacture up to 12 patient doses per day. Closed, automated systems like this enhance standardization, minimize contamination risks, reduce labor needs, and enable reliable scale-up.
Companies are also implementing single-use technologies, which improve flexibility and reduce validation and cleaning requirements, versus stainless steel equipment. According to BioPlan Associates, over 90% of cell therapy developers use single-use equipment, especially for upstream processes like cell culture. Improving cell stability and optimizing media, buffer and reagent formulations enhances cell viability and process yields.
Cell Therapy Manufacturing: Advanced Analytical Tools for Quality Control
Rigorous quality control testing is mandatory during cell therapy manufacturing to ensure safety, identity, purity and potency. Developers are implementing advanced analytical methods like spectroscopy, chromatography, PCR, and flow cytometry for in-process monitoring and release testing.
UniLine Automated Solution from Sartorius enables automated at-line sampling of bioreactors with biocontainer-sensor assemblies for Real-Time Cell Culture Monitoring (RT-CCM) and process optimization. As per Sartorius, with UniLine’s Vi-CELL BLU Cell density and viability data is automatically gathered every 20 minutes, enabling tight process control.
Companies like Berkeley Lights (United States) are also leveraging optofluidic technology and machine learning for cell line development and antibody discovery – analyzing thousands of single cells and selecting high-performing clones with optimized workflows.
End-to-End Quality in Cell Therapy Logistics: Navigating Supply Chain Hurdles
As cell therapies approach commercialization, developers encounter challenges in establishing scaled-up supply chains that span from raw material sourcing to final dose delivery. The limited shelf lives of living cell products, stringent cold chain requirements, logistics, traceability, and specialized handling/transport are key considerations in this process. In this regard, supply chain digitization and predictive analytics can help mitigate risks of temperature excursions or delays.
Two key examples are stated below–
- Cryoport, through its C3 platform, provides optimized end-to-end cold chain logistics solutions for cell therapy delivery using cloud-based monitoring and tracking.
- Savsu offers innovative EVO smart passive shipping containers enabling remote temperature monitoring.
As cell therapies move from promise to reality, innovations in bioprocessing are critical to overcoming the distinct manufacturing challenges these products pose. By investing in scalable and flexible solutions, automating & standardizing processes, and strengthening supply chains, the potential of engineered cell therapies can progress from lab to clinic and, subsequently, to patients in need. Though hurdles remain, continued progress and collaboration across this sphere can further accelerate the expansion of the global cell therapy bioprocessing market.
By Kiran Raut
The global cell therapy bioprocessing market’s growth is accredited to increased research and development in cell-based therapies, advancements in biotechnology, the rising prevalence of chronic diseases, and supportive regulatory environments.
Challenges in the cell therapy bioprocessing market include complexities in manufacturing consistent cell therapies, high research costs, stringent regulations, and logistical hurdles. On the other hand, market opportunities include developing better manufacturing techniques, exploring new therapeutic applications, and expanding into emerging sectors, leading to innovation and industry growth.