The Automation Challenge of 'Bioprocess 4.0'
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The Automation Challenge of ‘Bioprocess 4.0’

Drug development technology is evolving rapidly, creating new opportunities for the pharmaceutical industry to produce high-quality targeted large molecule drugs such as biologics and biosimilars.

The combination of strict quality guidelines and a complex final product can lead to too much rejected product and slow the pace of drug development. Biologics tend to be large, complicated molecules, which can present a challenge for manufacturing at scale. The COVID-19 pandemic has further slowed the pace of development in many instances, as a result of necessary changes in drug manufacturing. Required social distancing, remote monitoring, and lack of access to key drug ingredients can lead to bottlenecks.

The good news is there’s a solution. The pharmaceutical industry’s focus on safety and consistency of product, as well as a necessary return on investment, has increased adoption of automation in the drug development setting.

Benefits of automation in drug development

The value of automation in the lab setting has become even more visible during the COVID-19 pandemic. The push for automation was driven by the increasing demand for biologics, particularly monoclonal antibodies. Prior to the introduction of automation, biologics developers relied on in-person staffing and use of instruments that required a high degree of human interaction. Influenced by factors ranging from cost savings to tightening audit requirements, drug developers began to realize the value of smart manufacturing, which can produce and collect vast amounts of data about a product and its quality. Indeed, this era of drug development and manufacturing, referred to as “bioprocess 4.0,” found labs actively investigating the application of digitized data.

As the COVID-19 death toll soared and social distancing became more complicated, the pharmaceutical industry unified efforts toward timely vaccine development and repurposing of existing drug products into antiviral therapies. Faced with staffing restrictions and supply chain constraints, pharmaceutical companies accelerated the adoption of automation to enable remote monitoring as well as scale production in shifts to maintain a socially-distanced safe environment. Automation allows for sample batches to be run around the clock and with less in-person monitoring; in addition, increased batch consistency has been shown to help with conservation of key components, including adjuvants and reactants.

Automation and digitization also allow for the collection of vast amounts of quality assurance data, which can facilitate a robust audit trail and lend itself to predictive modeling efforts. Enhanced data collection assists in monitoring quality measures in real time and increases the likelihood that a product will remain on schedule throughout the drug development process, via achievement of critical quality attributes (CQA) and quality by design (QBD) targets. This presents an obvious financial benefit in the form of cost savings and helps to ensure safety and reliability of the final product.

Challenges of automation

The use of automation in biologic drug development also brings unique challenges. Most obvious is the initial financial investment. Automated instruments require specific software and configuring this software can be expensive and time-consuming. Industry experts tend to recommend a thorough evaluation of laboratory needs as well as a careful assessment of all relevant automation options, in the interest of avoiding overspending. Although the transition to new instruments and technology can be costly, the long-term ROI of increased volume appears to support the migration.

An evaluation of specific drug development needs will also help prevent what is known as “insufficient gains,” which can occur when a lab selects an automation setup that is not capable of comprehensive support of Process Analytical Technology (PAT) and CQA targets. There are a number of integrated automation solutions on the market, which can be tailored to client needs. These integrated solutions can streamline lab workflow and reduce overall service costs.

Ensuring optimal restructuring of lab workflow is also important, as it can help remedy any immediate backlogs during the transition to a full- or partially automated system. Beyond this, staff will likely need to be re-deployed into new roles.

As the healthcare industry needs to evolve under increasingly uncertain conditions, pharmaceutical companies have begun to recognize the value of automation in remaining agile and responsive to unforeseen circumstances.

For more details on the benefits and challenges of automation, please visit our white paper on the subject.

References

  1. Hong, Moo Sun et al. “Process Analytical Technology and Digital Biomanufacturing of Monoclonal Antibodies.” American Pharmaceutical Review. Published online Oct. 21, 2020. URL: https://www.americanpharmaceuticalreview.com/Featured-Articles/569427-Process-Analytical-Technology-and-Digital-Biomanufacturing-of-Monoclonal-Antibodies/
  2. Anis Khimani, PhD. Interview conducted Nov. 25, 2020.
  3. Vulto, Arnold G, and Orlando A Jaquez. “The process defines the product: what really matters in biosimilar design and production?” Rheumatology (Oxford, England) 56,suppl_4 (2017): iv14-iv29. doi:10.1093/rheumatology/kex278
  4. Agbogbo, F.K., Ecker, D.M., Farrand, A. et al. Current perspectives on biosimilars. J Ind Microbiol Biotechnol 46, 1297–1311 (2019). https://doi.org/10.1007/s10295-019-02216-z
  5. Kabir, Eva Rahman et al. “The Breakthrough of Biosimilars: A Twist in the Narrative of Biological Therapy.” Biomolecules 9,9 410. 24 Aug. 2019, doi:10.3390/biom9090410
  6. S. Food & Drug Administration. “Developing and Manufacturing Drugs Including Biologics.” Web page accessed Nov. 23, 2020. URL: https://www.fda.gov/drugs/coronavirus-covid-19-drugs/developing-and-manufacturing-drugs-including-biologics
  7. Yu, L. X., Amidon, G., Khan, M. A., Hoag, S. W., Polli, J., Raju, G. K., & Woodcock, J. (2014). Understanding pharmaceutical quality by design. The AAPS journal, 16(4), 771–783. https://doi.org/10.1208/s12248-014-9598-3
  8. S. Food and Drug Administration. Guidance for Industry: Q8 (2) Pharmaceutical Development. 2009
  9. Juran JM. Juran on quality by design: the new steps for planning quality into goods and services. New York: The Free Press; 1992.
  10. Guidance for Industry: PAT – A Framework for Innovative Pharmaceutical Development, Manufacturing, and Quality Assurance. Rockville, MD: Food and Drug Administration; 2004.

 

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