January/February 2025

COVER

SPECIAL FEATURE - Analytical Testing – Diverse Demands & Therapies Require Diverse Analyses

Contributor Cindy H. Dubin highlights how analytical testing has evolved to address diverse pharmaceutical therapeutics in research and development.

FEATURES

SPECIAL FEATURE - Analytical Testing – Diverse Demands & Therapies Require Diverse Analyses

Contributor Cindy H. Dubin highlights how analytical testing has evolved to address diverse pharmaceutical therapeutics in research and development.

LEADERSHIP PANEL - What Will Have the Most Impact on Drug Development in 2025?

Contributor Cindy H. Dubin asked several life science leaders what they believe will have the greatest impact on drug development in 2025.

FORMULATION FORUM - Nanoparticle Technologies for Oral Delivery of Peptides & Proteins

Jim Huang, PhD, and Shaukat Ali, PhD, examine various nanoparticle technologies in oral delivery of large molecules.

MICRONEEDLE MANUFACTURING - The Value of a Manufacturing-Oriented Microneedle Mindset

Andrew Riso says despite the significant buzz surrounding microneedle technology, a considerable gap remains between innovations and market-ready products. While early stage development and preclinical studies have shown promising results, the challenge of translating these advancements into scalable, commercially viable products persists.

EXECUTIVE INTERVIEW - Resilience Rising: Advancing Therapies That Transform Lives

Dr. Susan Billings, Chief Commercial Officer of Resilience, discusses pressing issues in the CDMO space, the opportunities driving innovation, and how her company is shaping the future of drug substance and drug product manufacturing.

DRUG DEVELOPMENT - What is Formulation Development & Why is it Important?

Rob Holgate, PhD, and Nicola Watts, PhD, explain how this process involves a delicate balance of scientific rigor and practical application, and not only requires a profound understanding of the drug's properties, but also the ability to navigate the many challenges of delivering the drug in an effective and patient-centric manner.

EXECUTIVE INTERVIEW - Lifecore Biomedical: Capacity to Keep Pace With Biologics Growth

Drug Development & Delivery recently interviewed Thomas Guldager, Vice President, Operations at Lifecore. With a 40+ year regulatory track record, Lifecore is a fully integrated CDMO with highly differentiated capabilities in the development, fill and finish of sterile injectable pharmaceuticals, including 20+ commercial products.

VACCINE DEVELOPMENT - Enhancing Pandemic Preparedness With Mosaic-8b Nanoparticles

Leonardo Magneschi, PhD, says although the mosaic-8b vaccine is still in early development, it has the potential to enable a broad and cross-reactive immunization strategy that could provide comprehensive protection against known and unknown sarbecoviruses.

OUTSOURCING PHARMA DEVELOPMENT - Harnessing CDMOs for Innovation & Efficiency

Rohtash Kumar, PhD, says a strategic partnership with a trusted CDMO can provide many benefits ranging from experts’ insights to state-of-the-art equipment. However, there are several considerations that developers should evaluate prior to engaging with a CDMO to maximize their partnership.

NEW PRODUCT INTRODUCTION - Addressing the Pitfalls of Progressing From Pilot to Product Through Effective New Product Introduction

Uwe Hanenberg, PhD, Wolfram Bühler, and Radoslaw Kaczanowski, PhD, explore the risks and challenges pharmaceutical companies face when undertaking NPI to ensure new products successfully reach the market and patients and examine the strategies CDMOs are adopting to ensure the smooth delivery of these projects from discovery to commercialization.

CELL SEPARATION TECHNOLOGY - Breaking Down Barriers to Unlock a New Era of Cell Therapy

Dr. Liping Yu believes revolutionary cell separation technologies are crucial for enabling these rapid advancements, and will continue to play a growing role in establishing the decentralized, rapid, and cost-effective large-scale manufacture of potentially life-saving cell-based drugs well into the future.

OXYGEN SCAVENGING - Innovative Oxygen Scavenging Technologies for Pharmaceutical Packaging: Ensuring Drug Integrity & Stability

Amanda Murph, Ivy Comer, Jason Pratt, PhD, and Jean Daou, PhD, believe by incorporating novel active materials science technology into active packaging solutions to actively remove oxygen from the packaging headspace, pharma companies can ensure the stability and efficacy of products throughout shelf-life.

FOCUSED ULTRASOUND - Overcoming Drug Delivery Challenges

Neal F. Kassell, MD, says one promising approach, focused ultrasound (FUS), is emerging as a revolutionary tool, enabling non-invasive, targeted BBB disruption. This method holds transformative potential in delivering therapies for neurodegenerative diseases and other challenging conditions, setting the stage for novel treatments in the years ahead.