PharmTech Weekly Roundup—September 11, 2026

This week on PharmTech.com, resilience was discussed in a variety of ways. CDMOs and equipment makers are gearing up for CPHI Milan, regulators are formalizing new frameworks, and manufacturers are treating validation and clinical logistics as safeguards rather than paperwork. From European legislation to Latin American customs delays, it appears that building systems robustly may be enough to withstand global complexity.

Upcoming Conferences

In conference news this week, Shilpa Medicare is spinning off Shilpa CDMO as a dedicated complex small-molecule contract manufacturer, with CEO Keshav Bhutada positioning the new brand’s peptide, ADC, and oligonucleotide capabilities for biotechs looking beyond China. The new CDMO will launch at this year’s CPHI Milan.

IMA Group will bring its five-division, all-in-one supplier pitch to CPHI Milan, headlined by a magnetic-levitation TILE-X fill-finish line for particulate-sensitive biologics and a semi-automatic X PEN LAB platform for clinical-scale injectable assembly.

At AAPS PharmSci 360 in October, Alfred Rumondor and Swita Singh will tackle CMC’s frontier problems. In an interview with PharmTech about their upcoming presentation, Singh suggested companies build controls around cell and gene therapies with no regulatory precedent, and Rumondor sees AI as an accelerant, not a replacement, for experimentation like solid-form selection.

Expert Commentary

Technical features and expert commentary on PharmTech.com this week spanned a variety of topics.

In her European Regulatory Watch column, Cheryl Barton walked through Europe’s fast-moving regulatory calendar, from AI Act transparency rules and new shortage-prevention templates to a pilot inviting non-animal testing data, as the long-anticipated EU Pharma Package edges toward full operation by 2028.

Christy Owings of Thermo Fisher explained how AI is reshaping clinical supply chains by automating shipment coordination and surfacing shifts like Chinese biotech's pivot toward first approvals in Latin America, without displacing the in-country relationships that still make or break access to harder-to-reach regions.

Owings argued sponsors should vet importer-of-record partners at the protocol-design stage rather than as an afterthought, because a depot’s on-the-ground relationships with customs officials are often what keeps clinical shipments moving.

Owings also detailed how Latin America's customs volatility, including Mexico's random screening holds, can ripple stress across an entire trial organization, making early shipment-approval coordination essential to protecting drug integrity and timelines.

Sri Harsha Chakrapani made the case that oral solid dosage validation isn’t a paperwork exercise but a technical control system protecting a plant’s ability to keep producing and releasing product without interruption.

Sherry Gu of WuXi Biologics unpacked why technology transfer outcomes vary so widely between sites even when sponsors follow the same playbook, and what separates transfers that scale smoothly from those that stall.

Taken together, this week's stories show that resilience in pharma isn't one initiative. It takes capacity investment, regulatory literacy, rigorous validation, and hands-on trial logistics all doing their part to keep supply chains intact.