Kaitlyn Vap - Lead Product Application Specialist SUEZ – Water Technologies & Solutions
Hayden Skalski - Product Application Specialist - Biodetection SUEZ – Water Technologies & Solutions
How has the COVID-19 pandemic affected the biopharmaceutical industry in respect to:
Manufacturing capability/capacity:
Vap: Biopharmaceutical companies obtain research and development expertise to progress pipeline development projects. While these companies also have internal manufacturing expertise, it is often not to the scale of contract development and manufacturing organizations (CDMOs). For this reason, much of pharmaceutical manufacturing is outsourced to CDMOs. COVID-19 put a strain on biopharmaceutical manufacturing capabilities, forcing biopharmaceutical companies to lean on CDMOs for scaled-up manufacturing of vaccines. In doing so, this led to productive collaborations, leveraging pharmaceutical company’s R&D expertise for vaccine development and CDMO’s expertise in manufacturing for vaccine production.
Regional dependencies also emerged in biopharmaceutical manufacturing. For economic reasons, manufacturing sites are typically limited for both biopharmaceutical companies and CDMOs. During the pandemic, the geographical isolation of manufacturing manifested into supply chain issues. Biopharmaceutical companies and CDMOs are now looking into constructing more small-scale manufacturing sites locally rather than a few large manufacturing sites globally to better meet and serve population demand.
Navigating the regulatory environment:
Rarely does the government directly call upon pharmaceutical companies for solutions; however, the COVID-19 pandemic served as a case in which this happened. Regulatory agencies affiliated with government bodies that catalyzed urgency for a solution to COVID-19 paralleled that same sense of urgency in their regulatory drug approval process. For this reason, faster times to market were observed with COVID-19 vaccines.
Emergency use authorization (EUA) was granted from the FDA for the administration of the Pfizer/BioNTech, Moderna, and Johnson & Johnson vaccines. EUA is not equivalent to final FDA approval, but still requires a high level of scrutiny through the collection of efficacy and safety data. More recently Pfizer/BioNTech’s vaccine received official FDA approval. This approval ultimately comes years ahead of the standard 7-10-year process of clinical trials to FDA approval. Because the regulatory environment shifted all resources and efforts towards COVID-19 treatments, the expedited approval was achievable. In the future it is doubtful the regulatory approval timeline seen with COVID-19 vaccines will be replicated due to the reallocation of resources and efforts amongst various preclinical, phase 1, phase 2, and phase 3 clinical trials.
New drug development programs:
Drug development has always been associated with lengthy time to market. Between identifying disease indications to target, developing a drug to effectively target those indications, and evaluating that drug in clinical trials, the process of propelling a drug to market can take years. Limiting factors that arise through the years it takes to bring a drug to market include cost and safety.
The drug development timeline was catalyzed during the development of COVID-19 vaccines not only because significant government funding and willingness from the general population to partake in clinical trials, but also because the alliances built between pharmaceutical companies offered transparency. Typically, pharmaceutical companies are competing to develop a drug that will treat the same disease. Maybe they are pursing different therapeutic modalities offering different mechanisms of treatment, nonetheless, the first to market generally wins majority market share. With COVID-19 vaccine development, the environment was different; pharmaceutical companies openly shared data with each other and partnered to expedite costly development efforts and lengthy safety evaluations. Alliances between companies ultimately drove efficiency while maintaining safety, for these reasons, collaborations on drug development projects will likely be adopted in the future.
Supply chain/cold chain weaknesses/limitations:
Nearly every industry suffered from supply chain limitations throughout the pandemic. Operation Warp Speed (OWS) is a government-initiated strategy to ensure every American who wants a COVID-19 vaccine will receive one. To alleviate the biopharmaceutical industry’s supply chain sourcing challenges, OWS requires raw material vendors to first reserve and allocate material for the production of COVID-19 vaccines and supply to other sources thereafter. While OWS has helped mitigate supply chain risks associated with the COVID-19 pandemic, the industry is considering how to instill fail-safes to mitigate these issues in the future. Current remediation efforts include maintaining larger inventory, identifying secondary and tertiary vendors, and building facilities closer to critical supplier locations.
Cold chain is a difficult to control form of supply due to many external factors – infrastructure, transportation, packaging, environment, etc.; however, the biopharmaceutical industry has had to overcome these challenges considering the extremely low storage temperatures required for mRNA vaccines. Taking a collaborative approach, suppliers, distributors, and end-users have implemented appropriate transportation, monitoring external weather and internal temperature experienced by modes of transportation. Furthermore, suppliers and distributors have worked to ensure vaccine sites are equipped with the necessary infrastructure by either constructing or verifying temperature-controlled facilities are in place.
Staffing and operations:
With the onsite workforce limited to essential employees, biopharmaceutical companies have had to learn to effectively communicate while physically disconnected from the office. Differentiated skillsets have emerged from this work model. Those who work from home are Supporters. It is key for Supporters to drive strategy and initiatives. On the other hand, those who work in the office are Operators. Operators perform the essential work that requires tactical execution.
Beyond these distinguished staffing groups that have emerged, each with their own strengths to drive effective communication, operations have shifted towards a customer-centric model rather than a product-centric model. The ability of the biopharmaceutical industry to adapt and focus on COVID-19 vaccines for their customers as opposed to pipeline development projects is largely due to the resilience of employees. Processes, on the other hand, have required retrofitting to cater to new product development and production. To avoid this roadblock in the future, biopharmaceutical companies have worked to generate methods and protocols that make development and production facilities adaptable for on demand shifts in product production. Cleaning methods and validation, versatile equipment, automated production, and artificial intelligence are a few ways the biopharmaceutical industry is preparing for the future of operations.
Financial considerations and growth forecast:
While many might assume COVID-19 positively impacted growth rates of pharmaceutical companies, compound annual growth rates (CAGR) were analogous to those in pre-pandemic years. This is largely due to biopharmaceutical companies sacrificing the production of other product lines in order to keep up with demand for COVID-19 vaccines. While the well-known COVID-19 pharmaceutical competitors include Moderna, Pfizer, BioNTech, and Johnson & Johnson, there were many more companies looking for solutions to treat COVID-19, ultimately shifting the entire biopharmaceutical industry’s focus away from pipeline development projects and commercially available pharmaceuticals.
Growth forecasts in future years will be difficult to predict as pipeline projects and commercial pharmaceutical production resumes along with maintaining COVID-19 vaccine research, development, and production. During the pandemic, grants that are typically awarded to fund research and development projects went to funding production/manufacturing suites. This investment in optimized manufacturing capacity has prepared the biopharmaceutical industry for future growth in product demand and expansion to product lines.
Looking forward, how will the biopharmaceutical industry take the knowledge and lessons learned during the COVID-19 pandemic and leverage this information to create a robust and nimble industry that is prepared for future pandemics?
Vap: COVID-19 challenged the biopharmaceutical industry not only from a research and development perspective in the development of COVID-19 vaccines, but also from a manufacturing perspective. Between maintaining production lines for existing pharmaceutical products and introducing COVID-19 vaccine production lines, the biopharmaceutical industry suffered from the lack of preparation and redundancy built into processes to withstand the high throughput experienced due to the pandemic. Demand increased, supply decreased, and the essential workforce risked exposure to COVID-19. To combat these challenges, the biopharmaceutical industry is more strongly considering implementing automated processes in lieu of industry standard manual laboratory practices. These automated processes could include the real time release of water for production, online cleaning validation, production line robotics, artificial intelligence, etc. Automation will ultimately help prepare the biopharmaceutical industry to face future pandemics by leaning out and streamlining processes. Maintaining laboratory equipment and training will ensure redundancy should any automated process malfunction. By decreasing reliance on manual practices, the biopharmaceutical industry is moving towards more robust, technologically advanced protocols, processes, and systems.
Skalski: Looking forward, biopharmaceutical companies should take advantage of new technologies and automation to create robust, reliable practices that help bring new products to market more effectively, safely, and in compliance with all regulations. We now know vaccines can be produced in record time, so deploying automated technologies to support production efforts will enable the product to reach patients quicker.
Additionally, with labor shortages and supply chain challenges seen during COVID-19, it is a good reminder for companies - and specifically QC labs - to have validated second suppliers for critical release tests so new medicines/vaccines can be released in a timely manner. By adopting automated technologies that reduce human error and improve data integrity, time spent training employees is significantly reduced, and companies are better prepared to minimize or eliminate any disruptions to product testing if there is a labor shortage. Having seen the issues in the biopharma industry during this pandemic, adopting innovative solutions to keep up with innovative medicines will only better support these companies for a successful response.
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