The growing global demand for new therapeutics and vaccines, which has intensified due to the COVID-19 pandemic, is creating a seismic shift in development and manufacturing.
The three major drivers in today’s manufacturing: speed, scale and scope
1. Speed: Reflecting the need to move at unprecedented speed, processes are being accelerated and steps traditionally run in sequence are now executed in parallel.
2. Scale: The scale of manufacturing is also radically changing. Commercial manufacturing of pandemic-related therapeutics and vaccines will not be measured in millions of doses, but in billions. To achieve this remarkable scale, manufacturers are increasing their production capacity “at risk”, before knowing that a vaccine candidate will be safe and effective.
3. Scope: Biopharmaceutical manufacturing now covers a wider range of drug modalities, including biologics, sterile injectables, vaccines, cell and gene therapies. The processes for these complex therapeutics demand new standards for automation, sterility, speed and quality.
One factor that remains constant: quality
What won’t change in the new manufacturing paradigm is the need to ensure in-process and final product quality. Quality control (QC) measures that monitor workflows and detect microbial contamination continue to be mission-critical, particularly in enabling increased speed and capacity. In the race to get new therapeutics and vaccines approved and manufactured at the scale required to respond to a global pandemic, inadequate QC processes and systems can expose companies to greater risk and jeopardize data integrity.
Conventional QC processes are slow, error-prone and labor-intensive. They struggle to match the time-to-results needed for even pre-pandemic workflows, let alone accelerated manufacturing paradigms in a post-COVID world. QC processes will be further strained as drug manufacturers operate with reduced staff levels and minimized human interaction required under social distancing guidelines.
Quality at the speed of progress
Demand for automated QC solutions is growing rapidly, particularly among manufacturers of novel complex therapies. The majority of the top 20 biopharmaceutical companies have adopted the leading automated QC solution, the Growth Direct™ platform, from Rapid Micro Biosystems. This includes deployment of the platform in the commercial manufacture of the most innovative treatments, such as CAR T-cell therapies.
Growth Direct offers fully automated and accelerated monitoring and detection of microbial contamination, a critical cornerstone of QC in drug manufacturing. As an automated, high-throughput platform, it replaces slow, error-prone, manual QC processes, allowing manufacturers to accelerate bioprocessing, maximize capacity, and reduce operational risk and downtime, all while maintaining the highest standards of data integrity.
The automated platform also supports bioprocesses where speed and capacity are at a premium, such as those that will be used in COVID-19 vaccine manufacturing. Importantly, this high-throughput platform can be operated with minimal human interaction. Remote monitoring capabilities further maximize efficiency and ensure manufacturing continuity at a time when QC labs must be fully operational but still observe social distancing requirements.
There is global interest in investing in technologies that advance a new biopharmaceutical manufacturing paradigm. Rapid Micro Biosystems recently closed a financing which will enable the company to accelerate commercial expansion of its Growth Direct platform, expand global supply chains and manufacturing networks to meet growing demand, and bring new complimentary products to market, including those that can accelerate response to pandemics.
Yet even when the pandemic subsides and new therapeutics and vaccines are widely available, there will be no going back to conventional ways of manufacturing. Gains in speed, capacity and agility of workflows and infrastructure will become the new normal. A cornerstone of this race to keep pace will be the integration of automated, high-throughput approaches to QC. This foundational technology will continue to pave the way for increases in speed and capacity, accompanied by the necessary risk mitigation, data integrity and patient safety, that will help reshape our industry for years to come, for the benefit of all.
To learn more, please visit www.rapidmicrobio.com