Highlights from Pharma IQ Live: Pharmaceutical Manufacturing Automation 2022

This year’s pharmaceutical manufacturing automation event featured fireside chats with experts from Sandoz and the Medicines Manufacturing Innovation Centre (MMIC), along with a case study presentation from Procter & Gamble and an insightful discussion with MasterControl.  

The event kicked off with Procter and Gamble’s Global Director for IWS Manufacturing Excellence, Marc Winkelman, who presented the organization’s Integrated Work System (IWS), a program that has helped the company reduce costs, reduce inventory, improve productivity and drive employee satisfaction year-on-year.

“The first step we take is making sure that our teams and our factories have a very solid operational structure so that everything we automate is delivering money,” Winkelman said.

“Our site in Rakona is a digital lighthouse, but it didn't become that because we had the latest technologies. It became a lighthouse because of how we are using all those technologies. It is our people driving that progress and it is our operators who are developing apps in-house. That is the story I want to tell you – how do you bring your operators up to that level?”

From paper to automation

Next there was a discussion with Brian Curran, Senior Vice President of Manufacturing Excellence Customer Success at MasterControl, that focused on the shift from paper to electronic batch recording. Curran highlighted how reliant the industry remains on paper systems: “The vast majority, 70 or 80 percent of pharma manufacturing sites are still using paper” he said. “We all know the problems with paper, such as data integrity and legibility.”

Curran went on to explain why confusion arises when manufacturers move from paper to digital systems, leading to a phenomenon called “islands of automation”.

Dave Berry, Grand Challenge and Digital Strategy Lead at MMIC began his session by explaining his job title. “I'm probably one of the few people on earth with “grand” in their title who isn’t a vizir” he said.

Berry’s job title stems from his collaborative work across organizations within R&D to find solutions to industry-wide problems. Working at MMIC, a collaboration between technology innovation group CPI, the University of Strathclyde in Scotland, UK Research & Innovation, Scottish Enterprise, AstraZeneca and GSK, his initial focus is on technology translation for small molecule drug manufacture.

Berry gave an overview of the Pharmacy Automation for Clinical Efficiency (PACE) project, which is enabling digital systems to connect to a modular automation platform for clinical trials to be delivered faster and with more flexibility.

He also explained the importance of having a Good Manufacturing Practice (GMP) strategy in place: “Knowing what you need to be in control of and frequently reviewing, is key. From an automation perspective it is recognizing that we are not just looking at it from a parametric release perspective, there is also how you work up the legal information for QP certification to the market. That is why we absolutely have to start with a GMP control strategy.”

Frameworks for complex formulation

The last session of the day was a fireside chat with Sridevi Challa, Group Head for Formulation Development at Sandoz Development Centre, a division of Novartis.

Based in Hyderabad, Challa leads a group of interdisciplinary scientists, formulation experts and Quality by design (QbD) data science experts, providing scientific guidance and strategic planning for the development of complex drug products, including solid oral dosage and in silico digital twin approaches for smart manufacturing.

Challa began by explaining what the QbD approach involves. “QbD is a strategic process for development as well as for manufacturing. It is meant to ensure that the intended performance of a final product is as expected, both in terms of its purity and its efficacy. To achieve this requires a well-described framework of objectives and also proper risk management approaches.”

Challa discussed scaling up from R&D to manufacture using QbD, before delving into process analytical technology (PAT) for automation and the importance of interoperability. “PAT systems are highly likely to interface with multiple systems and devices, including instruments, analyzers, programmable logic controllers and potentially distributed control systems. Therefore, it is really crucial to select a PAT knowledge management platform that can communicate bi-directionally with multiple automation device and system vendors.”

Quick links

• How to automate the data lifecycle to accelerate drug discovery and delivery
• The benefits of drug reformulation
• Why R&D must digitalize and become data-centric

If you missed any of this year’s live sessions you can still watch them on demand by visiting Pharma IQ Live: Pharmaceutical Manufacturing Automation.