June 2024

COVER

PLATFORM TECHNOLOGY - Antibody Oligonucleotide Conjugates (AOCs™) - Revolutionizing a New Class of Targeted RNA Therapeutics

Arthur A. Levin, PhD, highlights the first-ever successful targeted delivery of RNA to muscle in humans, a revolutionary advancement for the field of RNA therapeutics that may help transform the opportunities to advance research targeting many previously untreatable diseases in the years ahead.

FEATURES

PLATFORM TECHNOLOGY - Antibody Oligonucleotide Conjugates (AOCs™) - Revolutionizing a New Class of Targeted RNA Therapeutics

Arthur A. Levin, PhD, highlights the first-ever successful targeted delivery of RNA to muscle in humans, a revolutionary advancement for the field of RNA therapeutics that may help transform the opportunities to advance research targeting many previously untreatable diseases in the years ahead.

SPECIAL FEATURE - Outsourcing Formulation Development & Manufacturing: Going Beyond the Science to Become True Partners

Contributor Cindy H. Dubin speaks with leading CDMOs about how they are adapting to bio/pharma client needs, their capabilities in handling complex molecules, and how they are transforming from specialist contractors to true partners.

FORMULATION FORUM - Advances in Drug Delivery by Antibody Drug Conjugates (ADCs)

Shaukat Ali, PhD, and Jim Huang, PhD, focus on two aspects of drug delivery through ADCs. One, where an antibody is conjugated via a ligand with functionalized LNPs carrying cytotoxic drugs; and two, where an antibody is conjugated directly with drug through a linker at the specific site.

AMORPHOUS SOLID DISPERSION SPECIATION - Impact of Polymer Chemistry & Drug Properties

Wesley K. Tatum, PhD, focuses on the use of in vitro techniques for characterizing ASD performance and on how these techniques can be used to help better understand the role of polymer chemistry in ASD performance.

EXECUTIVE INTERVIEW - Lonza: Navigating Today’s Challenges in Drug Solubility & Bioavailability

Adi Kaushal, Director and Technology Head, Bioavailability Enhancement at Lonza, discusses solubility and bioavailability challenges and Lonza’s approach.

DEVICE STUDY - Putting Auto-Injector Interchangeability to the Test

Alex Fong, MBA, says many factors need to be taken into account when deciding whether patients can successfully switch to a different drug delivery device because if patients struggle to cope with a new device, there is a risk they will miss out on vital doses of medication.

EXECUTIVE INTERVIEW - PCI Pharma Services: A Consultative Approach to High Potency Formulation Development

David O’Connell, Director of Scientific Affairs at PCI Pharma Services, explains how important it is to choose the right CDMO partner to accompany you throughout the drug product lifecycle.

THERAPEUTIC FOCUS - The Unmet Need of Agitation in Alzheimer’s Disease

Ram Mukunda, MS, and Evelyn Gutiérrez, and Claudia Grimaldi report on IGC-AD1, the first natural cannabinoid-based investigational drug to be tested in human FDA trials for the treatment of AD, which has shown promising results in treating agitation in Alzheimer’s patients.

CONTAINER PLATFORMS - Ready-to-Use Containers: Real Benefits, Important Challenges & Evolving Value

Gregor Deutschle and Gabriele Maier examine key benefits, dynamics driving the adoption of RTU container platforms, and several important areas of continuing evolution in the RTU market.

PFS MARKET TRENDS - Partnerships With Pharma Packaging Specialists Will be Key to PFS Product Success in 2024

Pieter Vercruysse says to overcome various challenges in 2024, pharma companies need to establish close partnerships with specialists focusing on PFS packaging.