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The pharmaceutical and life science sector has not escaped the effects of the pandemic, with employees working from home and only critical staff and visitors allowed to visit production sites. We’ve been reminded how fragile the world is, and how something we can’t see can wreak havoc on a global scale. The word ‘biologics’ is now commonplace on the world stage, and biologic manufacturers continue to search for a ‘100% vaccine’, which is an illustration of how the community is coming together to accelerate the response. Governed by strict regulations, few other industry sectors can claim they are regulated as stringently. With a vaccine set to be produced on a global scale, by multiple manufacturers who are under enormous pressure to deliver ‘the antidote’, how can they adhere to FDA regulations and comply with GMP in a fast-moving operation? How can their technical partner help them maximise their value chain?
The key drivers within this sector are well affirmed as: time-to-market, quality/regulations, flexibility, and efficiency. The ability to up-scale from clinical trials of small batches to full production, while maintaining quality, is paramount.
Before the COVID-19 pandemic, the Industry 4.0 evolution had already impacted the way pharma adopts new technologies and digitalises its manufacturing plants. The goal was to remain on top of the game by addressing the well-versed industry drivers. These factors have emanated from market forces, such as our demand for new medicines, new entrants into the market, uncertainty, complexity, and cost.
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