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The biopharmaceutical industry is under pressure to increase the speed and capacity of manufacturing, without sacrificing quality.  Growth in demand for novel therapeutics continues to strain existing capacity and drives the need for new strategies to accelerate bioprocessing.

The COVID-19 pandemic is significantly amplifying this pressure and pushing industry to rethink conventional development and manufacturing strategies. A recent New
England Journal of Medicine1 article highlighted this new paradigm, as hundreds of companies race to develop therapeutics and vaccines at “pandemic speed”:

  • Manufacturers face growing pressure to streamline their processes and run more activities in parallel.
  • Manufacturing development, scale-up, clinical lots, commercial scale production and validation of processes are occurring much earlier in the pharmaceutical value chain to support clinical development.
  • Manufacturers are investing in increased capacity “at-risk”, to prepare for vaccine manufacture, without knowing whether a candidate will be safe and effective.

The challenges facing industry extend beyond simply increasing speed and compressing timelines: It is also a matter of scale. Pandemic-related therapeutics and vaccines will be produced in the billions of doses—not millions—but the massively larger volumes will need to be manufactured in the context of complex social distancing guidelines designed to keep personnel safe.

Quality Control at a Crossroad

Innovative approaches to quality control (QC) that are faster, highly automated and
deliver the accuracy needed to support confident decision-making at a time of increased risk will support these goals. Current QC processes used to detect microbial contamination are simply too time- and labor-intensive. New technologies are needed to take QC processes to the next level of speed and sophistication to enable manufacturers of biopharmaceuticals and vaccines to meet regulatory requirements, sustain competitive advantage, and, ultimately, serve patient needs and safety.

A critical cornerstone of QC in drug manufacturing is the ability to monitor and detect microbial contamination. Rapid Micro Biosystems has developed an automated, high-throughput platform, Growth Direct™, that replaces slow, error-prone, manual QC processes, allowing manufacturers to confidently accelerate bioprocessing, maximize capacity, and reduce operational risk and downtime, all while maintaining the highest standards of data integrity.

The platform supports even those bioprocesses where speed and capacity are at a premium, such as preparing for COVID-19 vaccine manufacturing. Importantly, this high-throughput platform can be operated with minimal human interaction. Remote monitoring capabilities further maximize efficiency and minimize the number of lab employees required to run the tests, enabling social distancing.

Global Adoption of New QC Technology

Demand for automated QC technology is growing rapidly, particularly among manufacturers of biologics, sterile injectables, vaccines, cell and gene therapies. To date, the Growth Direct platform for microbial detection has been adopted by the majority of the top 20 biopharmaceutical companies and is used by industry leaders in their commercial manufacture of groundbreaking therapeutics, including complex biologics and cell and gene therapies.

There is global interest in investing in technologies that advance a new biopharmaceutical manufacturing paradigm. Rapid Micro Biosystems recently closed a round of financing which will enable the company to accelerate commercial expansion of the Growth Direct platform, and expand global supply chains and manufacturing networks to meet growing demand. The investment will also allow the company to bring new complimentary products to market, including those to accelerate response to pandemics.

A New Normal at Pandemic Speed

When the pandemic subsides and new treatments and vaccines are widely available, there will be no going back to conventional methods of manufacturing. Gains in speed, capacity and agility of workflows and infrastructure will become the new normal. A key element of this paradigm shift will be the integration of automated, high-throughput approaches to QC.  This cornerstone technology paves the way for increases in speed, capacity and patient safety, while reducing business risk and ensuring critical data integrity, setting the stage for the brave new world of manufacturing.

 

Reference
1. Lurie, N. et al. Developing COVID-19 vaccines at pandemic speed. New England Journal of Medicine. March 30, 2020.

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