BioPharm International® Formulation Advances eBook September 2026
From next-generation biologics to smarter capsule technology and cleaner supplier communication, this ebook brings together 4 insights at where formulation science is headed and what it takes to get complex therapies safely from lab to patient. Inside, readers will find a look into the stability challenges of emerging biologics such as antibody-drug conjugates and bispecifics, including real-world case studies on taming viscosity and solubility at high concentrations. The industry's accelerating shift from IV to subcutaneous delivery is discussed, unpacking the regulatory approvals, patient-outcome data, and market forces turning at-home biologic dosing into standard practice. On the drug-delivery-innovation side, a feature on a novel capsule-in-capsule platform shows how liquid and solid actives can be combined in a single dose to cut pill burden without sacrificing performance. Rounding this eBook out, an IPEC-Americas explainer shows how the Excipient Information Package can replace slow, inconsistent supplier questionnaires with a standardized format that speeds qualification from months to days.
Accelerated approval for dostarlimab-gxly (Jemperli) pairs a single-arm phase 2 dataset with an FDA-authorized biomarker test and confirmatory requirements.
In the phase 3 SHINE-2 trial, half of pediatric patients who responded to mirikizumab induction were in clinical remission at week 52. Lilly plans to file for a pediatric UC label expansion.
Roche will take ex-China development of Hansoh’s two preclinical ADCs and multiple programs against Roche-proposed targets once Hansoh completes global phase 1a trials. The deal includes $400 million upfront and more than $15 billion in potential milestones.
Opus Genetics reports sustained vision gains with gene therapy, the FDA approves Roche’s Enspryng for at-home treatment of thyroid eye disease, and Estuary Biotherapeutics launches with $103 million to develop gene therapies for polycystic kidney disease.
When large pharmaceutical companies deprioritize drug candidates, smaller developers may license or acquire them, but due diligence, deal structure, and trial planning determine whether a program can move forward.