The global vaccination against COVID-19 is one of the biggest challenges ever faced by the pharmaceutical industry. In addition to managing the complexity of clinical trials and the supply chain involved in vaccine manufacturing, companies need to scale production at great speed while complying with regulations in multiple countries.

Business challenges like these are the target of startup Aizon, an artificial intelligence software provider that develops AI-powered solutions and analytics to optimize life science manufacturing.

“The main problem when you want to do a scale-up process is not only the equipment, it is also the knowledge that you have around your process,” said Toni Manzano (pictured), co-founder and chief scientific officer of Aizon. “AI is helping nowadays in order to detect and to identify the most relevant factors involved in the process, the critical relationship between the variables and the final control of all the full process following a continued process verification.”

Manzano spoke with Natalie Erlich, host of theCUBE, SiliconANGLE Media’s livestreaming studio, during the AWS Startup Showcase: The Next Big Things in AI, Security & Life Sciences. They discussed Aizon’s solutions for the pharmaceutical industry, the role of AI in science manufacturing, issues around compliance, and Aizon’s partnership with Amazon Web Services Inc. (* Disclosure below.)

Ensuring quality, safety and effectiveness

Equitable access to safe and effective vaccines is critical to ending the COVID-19 pandemic, according to the World Health Organization. This means that every country must have the vaccines and roll them out to protect their people, starting with the vulnerable. That way, the pharma companies that produce the doses need to send them to several countries. Given the volumes required, it often makes more sense to manufacture as close as possible to where the distribution is, according to Manzano.

Technologies can be part of the solution to safeguard against counterfeit doses, ensure quality across multiple locations and provide validation metrics, allowing pharma companies to provide the best safety and effective doses.

“How to control the full process from the initial phase till their packaging and the vials filling? AI is packaging all this knowledge in just AI models. This is the secret,” Manzano stated.

The Aizon platform integrates unlimited sources of structured and unstructured data to deliver actionable insights across all manufacturing sites. The idea is to offer an intuitive way to gain operational intelligence by enabling real-time visibility and predictive insights in a GxP-compliant manner with end-to-end data integrity.

“Probably, you can find a lot of AI services, platforms, programs software that can run in the industrial environment, but I think that it will be very difficult to find … a full GxP-compliant platform working on cloud with AI, when AI is already qualified,” Manzano said. “You will see that Aizon is the only company that is doing that nowadays.”

A key piece of this offer is the partnership with Amazon Web Services Inc., according to Manzano. Aizon relies on AWS cloud technologies, such as the machine-learning platform SageMaker, the user identity and data synchronization service Cognito and the serverless compute service Lambda, to facilitate its work.

“We are a very different startup company because we have a lot of Ph.D.’s … so, everything that is provided by Amazon, why do we have to aim to recreate again?” Manzano said. “AWS is simplifying a lot of our life, and we can dedicate all our knowledge and all our efforts to the things that we know: pharma compliance.”

Managing the complexity of distributed production

What Aizon does relates to the concept of Pharma 4.0, which refers to the moniker Industry 4.0, or the Fourth Industrial Revolution, where human intervention isn’t a part of the manufacturing process — smart technologies and machines perform all the roles, including process analysis and self-monitoring.

The benefits for pharma manufacturers implementing AI and cloud technologies are many. One of them is the possibility of managing the complexity of a global production or distribution, according to Manzano.

“You cannot create processes in order to manufacture drugs just considering that the raw material that you’re using is never changing; you cannot consider that all the equipment work in the same way; you cannot consider that your recipe will work in the same way in Brazil as in Singapore,” he said. “The complexity and the variability must be understood as part of the process.”

Another benefit is that the cloud allows companies to scale up or down whenever necessary and enables the use of other capabilities.

“You have not a big care about computing’s licenses, software updates, antivirals, scale up of cloud computing. Everything is done in the cloud,” Manzano explained.

Related to all of this is the possibility of dealing with compliance challenges in different parts of the world. Each country has its own rules, especially for a highly regulated industry like pharmaceuticals.

“I think that is the first time that the human race in the pharma experience have a very strong commitment … to push forward using these kind of technologies,” he highlighted. “Actually, for example, the FDA, they are using cloud to manage their own system. So, why not use them in pharma?”

Watch the complete video interview below, and be sure to check out more of SiliconANGLE’s and theCUBE’s coverage of the AWS Startup Showcase: The Next Big Things in AI, Security & Life Sciences. (* Disclosure: Aizon sponsored this segment of theCUBE. Neither Aizon nor other sponsors have editorial control over content on theCUBE or SiliconANGLE.)

Photo: SiliconANGLE