Dose #22: Reducing Downtime and Unlocking Capacity in Pharma with Andrea Wagner (PharmaPhixx)

In this episode of SCW for Pharma, Evren Ozkaya welcomes Andrea Wagner, CEO of PharmaPhixx. The conversation begins with Andrea’s professional background, spanning academia and industry. She holds a doctorate in toxicology and a master’s degree in analytical chemistry and spent the early part of her career in universities before transitioning into the pharmaceutical industry. Andrea later co-founded a CDMO, built a manufacturing operation from the ground up, and successfully exited the business (Berkshire Sterile Manufacturing). In 2023, she founded PharmaPhixx, a company focused on helping CMOs and CDMOs reduce the negative impact of production downtime by partnering with pharma manufacturers, OEMs, and engineering organizations. Andrea also highlights her commitment to mentoring women in engineering and pharma, noting that the “xx” in PharmaPhixx represents women.

Evren and Andrea then discuss her decision to build a CDMO and the challenges of entering a highly regulated and capital-intensive industry. Andrea explains that differentiation and deep customer understanding were critical in the early stages. She notes that it took approximately one and a half years after completing cleanroom construction and engineering work to secure the first customer, reflecting the long timelines required to make a pharmaceutical manufacturing site operational.

The discussion then shifts to the recent wave of domestic capacity investments in the United States following tariffs and geopolitical uncertainty. Evren asks whether the industry is facing a risk of overcapacity. Andrea explains that capacity constraints vary significantly by therapeutic area. While some segments clearly need additional capacity, others may already be saturated. She also emphasizes that regulatory approvals, team building, and customer trust take years, meaning new capacity cannot be activated quickly, even when investment decisions are made.

Evren connects this topic to overall equipment effectiveness (OEE) in pharma manufacturing, noting that average utilization rates remain around 35%, and are often even lower in sterile manufacturing due to extensive cleaning and changeover requirements. Andrea explains that PharmaPhixx focuses on improving availability and throughput by addressing downtime at the shop-floor level. She highlights automation, robotics, and AI as key enablers, particularly for repetitive tasks where digital systems can operate continuously and consistently, freeing up engineers and operators to focus on higher-value activities.

Evren and Andrea then discuss why pharmaceutical manufacturing has historically lagged behind other industries in digital transformation. Andrea expresses confidence that the pace of change is accelerating and predicts that most pharma factories will look fundamentally different within the next five to ten years. As the conversation turns to planning and budgeting, Andrea shares that digital transformation and patient safety would be her top priorities if she were still leading a CDMO. She explains that healthy data streams enabled by automation and analytics are essential for improving low capacity utilization and can deliver immediate impact on P&L performance.

They also explore the barriers that prevent faster adoption of digital solutions, including financial constraints, constant operational firefighting, and lack of long-term vision. Andrea argues that operations teams are best positioned to identify productivity and quality improvement opportunities, and that senior management’s role should be to provide them with time and bandwidth rather than relying solely on external advisors.

In the final part of the episode, the discussion turns to data availability and AI applications on the shop floor. Andrea notes that many factories still rely on paper-based systems or fragmented data, which significantly slows root cause analysis. She identifies quality inspection as one of the most impactful near-term AI use cases and stresses that digital batch records and digital logbooks are prerequisites for this application of AI. Andrea predicts that regulators such as the FDA and EMA will increasingly push for paperless quality systems, particularly as younger generations enter both the workforce and inspection bodies.

Evren and Andrea conclude the episode with advice for young professionals, especially women entering the pharma industry. Andrea encourages them not to be afraid, to support one another, and to actively seek mentorship, emphasizing her own openness to mentoring the next generation of leaders in pharma manufacturing.