Explore expert white papers on drug formulation, CDMO partnerships, biologics manufacturing, injectable development, cell and gene therapy and CMC strategy.
The approved variation enables Upperton to commence GMP manufacture of sterile investigational medicinal products from its purpose-built facility, expanding integrated development and manufacturing services to include sterile clinical supply.
Elizabeth Allen, PhD, Raymond Cook and Janet Rosasco from IQVIA's Early Phase Center of Excellence explore how biotechs can navigate uncertainty in early clinical development, including adaptive trial designs and AI-powered insights.
This white paper examines how AI-enabled route scouting, high-throughput experimentation and modern analytics help manage the growing complexity of small molecule APIs from early development to commercial supply.
This benchmark study analyzes the evolving bioconjugate and antibody-drug conjugate (ADC) landscape, covering linker-payload chemistry innovations and the criteria used to select a CDMO partner.
This eBook explores pharmaceutical classification models, bio-performance modeling, amorphous solid dispersions, precision particle engineering and first-in-human development, with expert perspectives on improving bioavailability.
Helen Clark, Head of Global MSAT at Bora Pharmaceuticals, shares insight on the capabilities needed to produce complex OSD drug products reliably in the U.S., covering HPAPI handling, Quality by Design and raw material planning.
Kevin Kane, PhD, CMC Strategy Director, shares insight on AI-assisted development, phase-appropriate supply strategies and coordinated clinical, CMC and manufacturing decision-making.
Asma Patel, VP at Quotient Sciences, addresses the biggest challenges in complex small molecule formulation development and provides a roadmap for keeping speed to clinic while reducing risk.
Anshul Gupte, PhD, VP of Pharmaceutical Development at PCI Pharma Services, discusses sterile manufacturing expansions and the value of co-locating development centers of excellence within GMP sterile facilities.
This white paper reveals the most common mistakes behind FDA Complete Response Letters related to E&L and offers practical, expert-backed strategies to build stronger programs that protect timelines.
