Featured Articles
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.
2025 COMPANY PROFILES & CAPABILITIES
For each participating company, this section presents a detailed summary highlighting their core technologies, capabilities, technologies, and services.
FORMULATION FORUM - Nanoparticle Technology for Nose-to-Brain Drug Delivery
Jim Huang, PhD, and Shaukat Ali, PhD, say as we continue our investigation of innovative delivery routes for drug molecules besides the parenteral and oral routes, the IN route remains the future method for drug delivery to the brain.
MULTILAYER PLASTIC VIALS - OXYCAPT™: Contributing to Stability of Cell & Gene Therapy Products
Shota Arakawa, MSc, and Tomohiro Suzuki believe OXYCAPT offers a multitude of benefits to the rapidly growing field of cell and gene therapy products.
DRUG DEVELOPMENT - Targeting the CD40L Pathway to Improve Immunosuppression Therapy & Help Organ Transplants Last Longer
David-Alexandre C. Gros, MD, explains how researchers are targeting strategies in immunosuppression that can help donated kidneys remain healthy and viable for much longer post-transplant, thus alleviating the need for repeat transplants and making more organs available for first-time transplant recipients.
MODIFIED RELEASE - Getting the Right Formula: Using Modified-Release Formulations to Address Complex Challenges in Drug Development
Vanessa Zann, PhD, presents the opportunities and challenges when transitioning from an IR to MR formulation, and reviews the therapeutic benefits and challenges associated with MR formulations, GI physiology environments and API physicochemical properties, technology choices, and how drug developers can achieve translation success.
DIGITIALIZATION PLATFORM - Breaking Down Communication Barriers in Pharma Manufacturing
Andreas Eschbach says a people-centered approach to digitizing manufacturing operations helps ensure the success of any digitalization initiative. But in pharmaceutical manufacturing, having insights into each area of operation is critical to production quality and compliance.
EXECUTVE INTERVIEW - Aptar: Advancing Patient-Centric Drug Delivery & Digital Health Solutions
Gael Touya, President of Aptar Pharma, and Sai Shankar, President, M&A, Strategy, BD, Marketing, Drug Services, Aptar Pharma, discuss the burgeoning potential in the future of pharma and digital health, how the company is a strategic partner to key players in these spaces, and the investments Aptar is making to support the growing demand.