As the biotechnology industry continues to grow, with a projected global market size of $775.3 billion by 2025, up from $417.2 billion in 2020, at a Compound Annual Growth Rate (CAGR) of 13.9% (1), the need for efficient and scalable biomanufacturing processes has become increasingly important. Biomanufacturing, which involves the use of living cells or their components to produce therapeutic proteins, vaccines, and other bioproducts, is a complex and highly regulated process. Scaling up biomanufacturing processes poses significant challenges, including ensuring consistent product quality, maintaining process efficiency, and managing costs. According to a survey by the Biotechnology Innovation Organization (BIO), 71% of biotech companies reported that scaling up biomanufacturing processes is a major challenge (2).
Technical Challenges
One of the major technical challenges in scaling up biomanufacturing processes is ensuring consistent product quality. This requires careful control of process parameters, such as temperature, pH, and cell density, to ensure that the final product meets the required specifications. Additionally, the use of single-use bioreactors and other disposable equipment can introduce variability in the process, making it difficult to maintain consistency. A study by the National Institute of Standards and Technology (NIST) found that the use of single-use bioreactors can result in a 10-20% variation in product quality (3). Some of the key technical challenges include:
- Cell line development and optimization
- Bioreactor design and scale-up
- Process control and automation
- Product purification and formulation
Human Resources and Training
Another significant challenge in scaling up biomanufacturing processes is the need for skilled and trained personnel. Biomanufacturing requires a multidisciplinary team with expertise in cell biology, biochemistry, engineering, and quality control. According to a report by the International Society for Pharmaceutical Engineering (ISPE), the biopharmaceutical industry will need to hire an additional 25,000-30,000 workers in the next 5 years to meet the growing demand for bioproducts (4). Some of the key human resources and training challenges include:
- Recruitment and retention of skilled personnel
- Training and development programs for biomanufacturing staff
- Knowledge management and transfer
- Collaboration and communication between different departments and teams
Business and Economic Challenges
Scaling up biomanufacturing processes also poses significant business and economic challenges. The cost of building and operating large-scale biomanufacturing facilities can be prohibitively expensive, with estimates ranging from $500 million to $1 billion or more (5). Additionally, the biomanufacturing industry is subject to strict regulations and guidelines, which can increase the time and cost of bringing new products to market. According to a report by the Tufts Center for the Study of Drug Development, the average cost of developing a new biologic is $1.3 billion, with a success rate of only 13.8% (6). Some of the key business and economic challenges include:
- High capital and operating costs
- Regulatory compliance and risk management
- Market competition and pricing pressure
- Supply chain management and logistics
Health Challenges
Finally, scaling up biomanufacturing processes also poses significant health challenges. Biomanufacturing involves the use of living cells and biological materials, which can pose risks to human health and the environment. According to a report by the World Health Organization (WHO), the use of biotechnology can pose risks to human health, including the potential for contamination and the release of genetically modified organisms (7). Some of the key health challenges include:
- Ensuring the safety of bioproducts for human use
- Preventing contamination and ensuring sterility
- Managing the risks associated with genetically modified organisms
- Protecting worker health and safety
In conclusion, scaling up biomanufacturing processes poses significant technical, human resources, business, and health challenges. To overcome these challenges, biotechnology companies must invest in research and development, training and education, and process optimization. Additionally, governments and regulatory agencies must provide support and guidance to ensure that the biomanufacturing industry can continue to grow and innovate while ensuring the safety and quality of bioproducts. As noted by the FDA, “the development of new biologic products and the expansion of existing manufacturing capacity will require a coordinated effort from industry, government, and academia” (8).
References:
(1) Grand View Research. (2020). Biotechnology Market Size, Share & Trends Analysis Report by Application (Biopharmaceuticals, Bioservices), by Technology (Nanobiotechnology, DNA Sequencing), by Region, and Segment Forecasts, 2020 – 2025.
(2) Biotechnology Innovation Organization. (2020). 2020 Biotech CEO Survey.
(3) National Institute of Standards and Technology. (2019). Single-Use Bioreactors: A Review of the Current State of the Art.
(4) International Society for Pharmaceutical Engineering. (2020). 2020 ISPE Biopharmaceutical Manufacturing Survey.
(5) BioPlan Associates. (2020). 17th Annual Report and Survey of Biopharmaceutical Manufacturing.
(6) Tufts Center for the Study of Drug Development. (2020). Cost of Developing a New Biologic.
(7) World Health Organization. (2019). Biotechnology and Human Health.
(8) FDA. (2020). Advancing Biotechnology Innovation.
