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The industry is feeling the push to modernize facilities and manufacturing processes.
This week’s stories reflect the push to modernize facilities and manufacturing processes, the mounting impact of trade policy on the supply chain, and the persistent challenge of getting the right drugs to patients reliably.
ISPE recognized six facilities across the year’s Facility of the Year Awards, with winners spanning synthetic DNA manufacturing, plasma fractionation, and cell therapy—recognizing the global standard for what pharmaceutical facilities can achieve.
The FDA has reached its key first-year goals under its 2025 Roadmap to Reducing Animal Testing, advancing new approach methodologies—including computational modeling and organ-on-a-chip systems—as more scientifically accurate alternatives to animal studies.
The US Customs and Border Protection launched its new tariff refund portal on April 20, 2026, providing a way for pharmaceutical importers to reclaim funds following a February Supreme Court rebuke of executive tariff authority.
Asahi Kasei has completed its acquisition of German biotech Aicuris, adding three antiviral assets targeting severe infections in immunocompromised patients—a move that deepens its specialty pharma platform in transplantation and infectious disease.
Our editors were at INTERPHEX in New York this week, attending conference sessions and interviewing experts. One of the sessions discussed how the next generation of cGMP facilities must balance automation, digital integration, and sustainability while meeting regulatory expectations—requiring manufacturers to rethink both design and operational strategies.
Todd Vaughn and Christa Myers of CRB Group talked with PharmTech about how contamination control requirements and revised GMP Annex 1 standards are driving robotics adoption in aseptic manufacturing, with fully automated, gloveless isolator systems moving from emerging technology to operational expectation.
Experts from Merck, AstraZeneca, J&J, Regeneron, and Basetwo AI expressed that, despite broad interest in AI across drug discovery and manufacturing, there are still barriers to AI adoption—with data fragmentation, regulatory uncertainty, and workforce skills gaps remaining the primary barriers to scale.
Optimized CDMO facility design is increasingly defined by flexibility—modular layouts, multi-product capability, and digital infrastructure—allowing contract manufacturers to onboard new programs faster while maintaining GMP compliance, according to Ranjit Deshmukh, Principal, BiologixCMC, who spoke with PharmTech ahead of his INTERPHEX quick fire session.
And Rohan Kumar, laboratory analyst at CS Analytical highlighted that while interest in sustainable pharmaceutical packaging is growing, significant gaps remain between industry ambitions and commercially viable, regulatory-compliant solutions.
This month’s Ask the Expert episode discusses how combination products present unique complaint investigation challenges because responsibility often spans multiple components and regulatory frameworks—making cross-functional coordination and clear root-cause methodology essential for compliance.
The industry is under pressure to modernize faster, build supply chains that can absorb disruption, and close the gap between technological ambition and operational reality. Stay current with industry news and trends at PharmTech.com.