SUS, PAT, And Other Tech Advancing Upstream Bioprocessing

By Pankaj Singh, Global Market Insights

An anticipated surge in demand for advanced therapeutic modalities predicates a considerable operational expansion for upstream bioprocessing.

Upstream bioprocessing involves the early stages of biopharmaceutical manufacturing, where cells are grown and cultivated to produce therapeutic proteins and other biological products. Key operations include media preparation, cell banking, inoculum expansion, and production bioreactor operations.

Process analytical technologies (PAT) are used to monitor and control critical quality attributes during upstream production. Once the target protein is expressed, the broth containing the protein is harvested and purified in downstream processing.

Biologics are well suited to treating conditions like cancer, autoimmune diseases, and diabetes. It is estimated that by 2050 more than 1.3 billion people could be living with diabetes worldwide, which is more than twice the number of diabetic people in 2021.

In order to support the development and production of biopharmaceuticals targeting intricate disease pathways with precision, companies working in this modality are racing to build capacity, optimize processes, and roll out advanced technology that improves efficiency.

Many major pharmaceutical companies face patent cliffs for small molecule drugs, with revenues declining as blockbuster drug patents expire. This has led to increased investments in biologics research to develop new therapies that can replace revenue lost from expiring patents on small molecules.

The global upstream bioprocessing market size should exceed $21.5 billion by 2032, says a new study published by Global Market Insights Inc. (GMI). A rapidly expanding biologics sector, investments in single-use technologies (SUT), process automation, and advances in cell line development and bioreactor designs will be the notable driving factors. Increasing outsourcing and growth in emerging economies could also fuel the industry forecast.

Upsurge In Single-Use Bioprocessing Systems

Single-use bioprocessing systems are gaining significant traction in the biopharmaceutical industry due to their various advantages. The prominent benefits include:

• Reduced risk of cross-contamination — Single-use bioprocess containers eliminate cleaning requirements between batches and reduce the risk of batch failure due to cross-contamination.
• Improved flexibility — Single-use systems allow biopharma companies to quickly reconfigure manufacturing lines for different products. This provides greater flexibility and efficiency.
• Faster changeovers — Changeover from one batch to the next is much faster with disposable systems compared to stainless steel, reducing downtime.
• Lower capital costs — Single-use systems require less capital investment compared to traditional bioreactors and fixed piping systems. This makes capacity expansion more affordable.

According to the GMI report, single-use systems accounted for nearly 40% share of the upstream bioprocessing industry during 2023, growing at a steady pace. As biologics manufacturing scales up to meet rising demand, single-use modalities such as bioreactors enable biopharma companies to construct flexible facilities faster. Companies can achieve higher throughputs at lower costs, steering the widespread adoption of disposable technology in upstream bioprocessing.

The segment is witnessing consistent developments to enhance biomanufacturing outputs, representing a key trend in the industry. To cite one instance, last year MarqMetrix announced the launch of the Single-Use BioReactor BallProbe to enhance the accuracy and repeatability of Raman measurements for liquids and solids without risking the purity of high-value batches.

Developed in response to the growing trends toward single-use solutions in the biopharmaceutical sector, this product aims at elevating efficiency, reducing operational costs, and minimizing the risk of contamination in critical manufacturing processes. This product development represents a significant innovation in the realm of biomanufacturing, potentially setting new standards in process monitoring and quality control, while simultaneously driving down the costs and complexities associated with biopharmaceutical production.

Value Of Process Analytical Technology

Process analytical technology refers to systems that provide real-time measurements and analysis of critical parameters during biopharmaceutical manufacturing. PAT helps to ensure final product quality by providing greater process understanding and control.

PAT can facilitate reduced waste and costs by improving process efficiency and productivity by detecting issues early. Other benefits include increased product quality and consistency by closely monitoring critical quality attributes, continuously verifying quality to lower regulatory burden, and faster, more efficient technology transfer through better process knowledge.

Adoption of PAT continues to increase in biopharmaceutical manufacturing. The U.S. FDA issued PAT guidance in 2004, ensuring regulatory support and incentives for organizations. In Europe, the European Medicines Agency (EMA) has been instrumental in offering regulatory frameworks that incorporate PAT methodologies. Advances in sensor technologies, automation, and data analytics are some other drivers for PAT deployment.

In October 2023, LumaCyte unveiled a redesigned Radiance instrument, an innovative process analytical technology, to cater to the increasing use of the company’s Laser Force Cytology precision analytics, especially suited for biomanufacturing plants having space constraints. The streamlined Radiance instrument represents not merely an advancement but a significant leap into the future of real-time precision analytics for cell-based production. This example is a testament to the evolving landscape of biomanufacturing, where efficiency, precision, and rapid response to market needs are paramount.

As biologics become more complex, PAT is seen as essential for enhancing process understanding and control. Leading biopharma companies are aggressively implementing PAT and integrating it with process development and manufacturing activities. This trend is expected to accelerate as PAT delivers significant quality, efficiency, and economic benefits.

Prospects From The Monoclonal Antibodies Segment

Monoclonal antibodies (mAbs) are a leading source of biologics revenue for biopharmaceutical companies. GMI states that over the period 2024-32, global upstream bioprocessing industry share from mAb applications will register over 9% CAGR in terms of value.

The major segments within mAbs are oncology, autoimmune diseases, and infectious diseases. Cancer incidence worldwide is increasing, catalyzing the expansion of the monoclonal antibodies therapeutics sector. As per the Global Cancer Observatory, the occurrence of cancer is expected to surge consistently by 2045, with breast cancer incidence growing by approximately 36.9%, melanoma by 36.7%, colorectal cancer by over 60%, and pancreatic cancer by around 67% compared to 2022 levels.

The clinical success of mAbs is expected to make them a primary area of focus for biopharmaceutical innovation over the next decade. Upstream bioprocessing emerges not merely as a pivotal phase but as a linchpin in the development and production of these therapeutic agents. The selection of an optimal cell line, for instance, is a critical determinant of the mAb's specificity and affinity for cancerous targets.

This step alone encapsulates the convergence of genetic engineering and molecular biology expertise, underscoring the necessity for precision and meticulousness in genetic manipulation to produce cell lines capable of expressing high-quality, functional mAbs. Excellence in upstream bioprocessing is not merely about efficiency or yield, it is about ensuring the therapeutic promise of oncology mAbs is fully realized, from the bioreactor to distribution.

Biopharmaceutical companies are investing heavily in next-generation antibody engineering technologies to improve efficacy, safety, and delivery. For example, in November 2023 AbbVie affirmed a $10.1 billion deal to acquire ImmunoGen and its flagship cancer therapy Elahere, along with the latter’s follow-on pipeline consisting of next-generation ADCs. Elahere is a first-in-class antibody-drug conjugate (ADC) targeting platinum-resistant ovarian cancer. ADCs are a sophisticated advancement in the application of mAbs in therapeutics.

Key Players In Upstream Bioprocessing Market

The industry is dominated by large biopharmaceutical companies with expertise in drug development and commercial manufacturing. Some of the key players in this market include:

• Amgen — The largest independent biotech company that develops and manufactures biological therapeutics. Amgen has expertise in upstream processes like cell culture and microbial fermentation.
• Genentech — A biotech company and subsidiary of Roche that is a pioneer in genetic engineering and biotechnology. It has leading capabilities in mammalian cell culture for monoclonal antibodies.
• Abbott Laboratories — A healthcare company with a strong biologics segment involved in upstream bioprocessing technologies. Abbott has expertise in microbial fermentation and cell culture processes.
• Johnson & Johnson — A diversified healthcare company with a biopharmaceuticals division Janssen. J&J has capabilities in microbial fermentation and mammalian cell culture.
• Sanofi — A European pharmaceutical company with biologics expertise in vaccine development and monoclonal antibodies manufacturing using microbial and cell culture processes.
• Lonza — A leading CDMO providing end-to-end bioprocessing solutions from cell line development to commercial manufacturing scale-up. Lonza has expertise across microbial, cell culture, and viral vector platforms.
• Boehringer Ingelheim — A pharmaceutical company with a biopharmaceutical segment involved in developing and manufacturing biologics like monoclonal antibodies using cell culture processes.
• Samsung Biologics — A Korean CDMO providing integrated biopharmaceutical manufacturing services with capabilities in upstream cell culture processes.

The expertise and scale of these players make them the leaders driving technology innovation and growth in the global upstream bioprocessing market. Their investments and focus on next-generation upstream processes will shape the future of biopharmaceutical manufacturing.

What Does The Future Hold For This Industry?

For industry professionals, investors, and researchers, understanding the intricacies of upstream bioprocessing is essential for appreciating the broader landscape of monoclonal antibodies, recombinant proteins, vaccines, cell and gene therapies, and other biologics.

These cutting-edge therapies involve more complex processes compared to traditional biologics.

Increased focus on improving flexibility, efficiency, quality, and reducing costs in biomanufacturing facilities will propel the adoption of innovative upstream technologies.

Strategic partnerships, acquisitions, and expansion plans by major players will shape the competitive landscape and fuel overall market growth.

Emphasis on deploying innovative upstream processes such as perfusion cell culture to improve productivity and yields will boost the sector forecast over the coming years, along with the adoption of high-yielding cell lines. With the need to create patient-specific, targeted therapeutic options, this market is poised to experience substantial growth and transformation, navigating the path from mass production toward more tailored, precision-based biomanufacturing.

About The Author:

Pankaj Singh is a writer at Global Market Insights who writes about business, technology, trade, and finance.