Navigating the Operational Tightrope in Pharmaceutical Manufacturing

In a rapidly shifting pharmaceutical environment, the role of CDMOs has become increasingly complex. Raj Puri, CCO at Argonaut Manufacturing, oversees operation of two distinct divisions: one for life science and diagnostic products and another for aseptic drug product filling. In this interview, Puri discusses the economic, regulatory, and human factors shaping the industry's future.

PharmTech: In an industry often defined by high-tech equipment, how does a CDMO set itself apart from other firms?

Puri: While anyone with sufficient capital can build a state-of-the-art facility, the only long-term sustainable advantage we have as a CDMO is our staff. Our executive team prioritizes getting and keeping the "right people on the bus.” As a midsize organization, we offer a dynamic environment where staff can work across various functional areas. This cross-training, where an operations professional understands the demands of Quality Assurance and vice-versa, creates an organization that truly understands the floor-level challenges of manufacturing. Our team’s intellectual curiosity drives us to adopt the latest technologies and techniques to remain on the cutting edge.

How are tariffs and massive manufacturing investments affecting the industry?

The implementation of tariffs has been the biggest and most unwelcome surprise of 2025, particularly those applied to equipment and consumables from non-US manufacturers. For Argonaut, which is completing a three-year investment plan for a new site, we were hit with a seven-figure tariff on a key piece of equipment. These costs have a chilling effect on investments because they make ROI calculations for multi-million dollar projects incredibly difficult.

We are also seeing north of $370 billion in announced investments for US manufacturing. If realized, this massive influx will likely extend construction timelines and increase costs significantly, disrupting the typical supply and demand curve. Simultaneously, if the government forces down pharmaceutical pricing, companies will be desperate to reduce their COGS. This creates an operational tightrope for CDMOs, we must find ways to lower costs while the FDA maintains its high expectations for product safety and manufacturing robustness.

How has the global climate changed how pharma companies view supply chains?

Geopolitical shocks and the lessons of COVID-19 have underscored the vital importance of redundancy. We are seeing a shift where biotech and pharma companies are looking to establish secondary manufacturing sites that are both geographically and economically segregated from their primary sites.

There is significant pressure to get products to market faster. What are the risks and rewards of compressed timelines?

Speed is critical for patient access and commercial viability. However, compressed timelines force companies to take a financial gamble, often requiring them to start mass production at the time of submission before receiving any indicative guidance from regulatory agencies.

I’ve seen cases where a Phase 3 study was discontinued early due to overwhelming efficacy. While this is a fantastic outcome for patients, it created a 6-8 month gap for data analysis and submission, leading to patient access issues before commercial approval. It also resulted in a smaller data set, leading to regulatory labels that required clinicians to use unfamiliar clinical trial severity scores. Ultimately, these compressed timelines require a robust contingency strategy and close coordination with regulatory bodies to negotiate allowances like rolling data submissions. They may even force companies to prioritize one jurisdiction, such as the FDA, over others due to differing requirements.