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.
Panelists on PharmTech AI Pulse Check debate SURPASS, a new digital-twin trial program, regulatory acceptance, and the data-cleanup burden it will create.
Boyang Wang of Immortal Dragons explains how FDA's Expedited IND Pilot and QRIs could compress sequential first-in-human steps as China's Decree 818 raises the pace.
The FDA expanded Anktiva to BCG-unresponsive papillary-only NMIBC using existing CIS trial data, a precedent with implications for development timelines and supply planning.
Ishani Maharaj of Ingredients + Specialties from Univar Solutions explains how to stabilize GLP-1 multi-agonists, weigh delivery formats, and qualify novel excipients and suppliers.