What is pharma manufacturing?

A breakdown of how flexible, digital and continuous manufacturing practices transforms pharma manufacturing processes with real-life case study examples from Merck, GSK and Ayala Pharmaceuticals

A roadmap to pharma manufacturing
Pharma manufacturing refers to the industrial-scale synthesis of pharmaceutical drugs. This is a process with many challenges and techniques that practitioners will need to be aware of to ensure that drug development is optimized. Doing so offers clear benefits for any pharma manufacturer, as optimized production will invariably have a positive impact on organizational profits. Numerous methods and tools can be applied to enhance manufacturing optimization efforts:

Digital manufacturing
The term digital manufacturing essentially encompasses the application of digital tools or techniques to optimize the manufacturing process. This could mean the application of data and analytics or leveraging advanced technologies such as artificial intelligence (AI).

These digital tools have been pivotal for enhancing the manufacturing process to combat uncertainty during the intense disruption caused by the Covid-19 pandemic. The rise of these digital tools ushered in the era of Industry 4.0, the ongoing automation of traditional manufacturing, with a report by Pharma IQ noting that 94 per cent of pharma manufacturing practitioners were able to continue operations as a result of Industry 4.0 solutions.

Similarly, the same report identified Industry 4.0 solutions in pharma manufacturing produced savings of 20 per cent while improving quality and making deliveries more reliable.

How digital manufacturing strengthens pharma’s product quality and speed-to-market (Source: Pharma IQ)
“The first thing pharma companies need to do to achieve digital transformation is understand where the gaps are and digitally connect the entire process. By finding opportunities in the face of uncertainty and translating industry challenges into solutions that permit continuous workflows, pharma companies will be able to respond to risk quickly and enhance enterprise performance.”

Brian Curran
Senior Vice President Customer Success for Manufacturing Excellence at MasterControl

Flexible manufacturing
Flexibility in the manufacturing process is key, particularly in response to sharp increases in demand, which is what the industry has seen with the global need for speedy production of the Covid-19 vaccine. As revealed in a report by Rockwell Automation, Critical considerations for deploying smart, fast and flexible life sciences facilities, flexible manufacturing could mean executing smaller batches, optimizing asset utilization or being first to a new market.

Implementation of flexible manufacturing facilities is on the rise, with many pharma manufacturers realizing the benefit of flexible tools such as single-use reactor bags, smart totes and mobile processing equipment. This allows organizations to quickly pivot the setup of the manufacturing process to respond to demand increases or enforced shifts in manufacturing focus.

A discussion with MSD and Dassault Systèmes on building flexible and agile manufacturing operations for affordable, accessible and safe healthcare (Source: Pharma IQ)
Continuous manufacturing
Continuous processing techniques and technologies are being favoured in the pharma industry to improve workflow productivity. As opposed to traditionally manufacturing drugs in predetermined batches, for example, continuous processing setups create an ongoing production cycle with no hold times, which allows for superior development speeds and enhanced process safety.

The improvements that continuous manufacturing offers includes reduced manufacturing costs, particularly in the long-term, shorter production times and reduced human error rates.

To achieve continuous quality assurance and product consistency in pharma manufacturing, see also: A Roadmap from batch to continuous manufacturing

Pharma IQ Live: Continuous Processing 2021

Continuous Processing offers substantial benefits over traditional batch processing methodologies, so much so that the US Food and Drug Administration (FDA) now actively supports the development of continuous improvement capabilities.

Register for this event to learn more about:

Increasing asset utilization by facilitating continuous production
Reducing process variability and supporting real time release through the use of Process Analytical Technologies (PAT)
Enabling predictive maintenance by leveraging real time data to identify issues

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