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June saw regulators look back at their achievements, take stock of drug shortages, and advance treatments for rare diseases.

June saw regulators look back at their achievements, take stock of drug shortages, and advance treatments for rare diseases.

This episode of Ask the Expert takes a look at recent regulatory actions impacting biologics manufacturers.

This week, the industrialization of advanced biologics, sustained regulatory and investment momentum behind next-generation therapeutics, and an ongoing push across the supply chain to improve standardization and efficiency were themes covered on PharmTech.

AI is reshaping GMP documentation and quality workflows, but human accountability remains non-negotiable, and the regulatory consequences for over-relying on AI are real.

MilliporeSigma's Sebastián Arana breaks down CGT manufacturing's biggest scale-up gaps and why supply chain collaboration is now essential.

In this episode of Drug Digest, experts from Sanofi, GxP Frame, and Open Biopharma explain how AI is transforming drug discovery, manufacturing, and workforce strategy and how strategic partnerships play a role.

At BIO 2026, Thermo Fisher's Anil Kane explains how AI is reshaping CDMO workflows and what biotechs should prioritize when choosing a development partner.

MilliporeSigma's Sebastián Arana explains why modular, digital, platform-based manufacturing, not raw capacity, will define biomanufacturing's next decade.

This episode of Pharma Fundamentals explains the difference between a quality system for biologics compared with small-molecule drugs and the Parenteral Drug Association’s revision to Technical Report No. 56.

This episode of Pharma Fundamentals explains the difference between a quality system for biologics compared with small-molecule drugs and the Parenteral Drug Association’s revision to Technical Report No. 56.

AI governance, nitrosamine risks, and surging US manufacturing investment reshape quality systems, deals, and workforce needs.

Success in emerging biopharma depends not only on speed, but also on making confident, data-informed decisions early in development while managing increasing molecular complexity.

Karianne Gelinas, LVEDC, outlines workforce strategies to fill 850 technical roles ahead of Eli Lilly's major Lehigh Valley manufacturing investment.

Lehigh Valley's deep manufacturing base, community college partnerships, and apprenticeship programs positioned the region to attract Eli Lilly's investment.

This week's headlines saw oncology investment; persistent pressure on supply chain resilience and drug availability; and the importance of operational readiness.

CAI's Jon Thompson explains how digital twins cut cleanroom rework by up to 50% and pressure excursion investigation time by up to 70%.

CAI's Jon Thompson details how digital twins cut cleanroom commissioning time by up to 30% and accelerate GMP deviation investigations.

Discover how a new mid-scale DynaDrive™ bioreactor platform and KojoX™ philosophy are redefining supply-chain security and manufacturing consistency across a growing global network.

Dr. Christine Allen, Co-Founder and CEO of Intrepid Labs, and Dr. Andrew Lewis, Chief Scientific Officer of Quotient Sciences, explain how AI can be used in drug development to shorten development timelines.

Sandra Coufal, Toragen, discusses her team's research targeting precancerous cervical cells, backed by a Gates Foundation grant and world-class advisors.

Sandra Coufal, Toragen, shares promising Phase I results showing dramatic HPV DNA reductions and tumor shrinkage, with Phase II set to confirm efficacy and safety.

Increased regulatory flexibility for rare diseases, a critical shift toward automated, data-driven manufacturing, and strategic acquisitions in genetic medicine were some of the highlights this week.

Ajay Damani, President of Coating Place, discusses the impact of the current CDMO landscape on oral solid dose pharmaceuticals.

Susan J. Schniepp, distinguished fellow at Nelson Labs, and Siegfried Schmitt, PhD, vice president, Technical at Parexel, provide advice on creating a robust out-of-specification procedure.

Sandra Coufal, MD, Toragen, discusses advancing TGNS15 with strong IP, liquid formulation, and an accelerated FDA pathway, potentially saving millions on IND-enabling studies.

Nicholas Richardson, vice president of clinical development at Precision for Medicine, explains why radiopharmaceuticals are unique for patients with cancer and what makes them challenging to develop for those patients.

Sandra Coufal, MD, Toragen, discusses how TGN-S15's preferred enantiomer showed no neurotoxicity and reduced tumor growth, supporting development of the oral cancer drug.

The evolution of Pace® Life Sciences from an analytical services firm to a full-service CDMO supporting the drug development lifecycle.

Discover how Piramal Pharma Solutions is innovating in integrated CDMO services, leveraging their Science Collective of experts to streamline drug substance and drug product programs from early development through commercialization.