BIOCATALYSIS - Biocatalysis Without Barriers for Efficient Small Molecule Process Development
Masha Kononov and Reuben Carr examine both the promise and the practical constraints of biocatalysis in modern drug substance development, as well as the role of contract research, development and manufacturing organizations (CRD-MOs) in meeting the evolving demands of modern small molecule synthesis.
SPECIAL FEATURE - PFS & Parenteral Manufacturing: Rapid Growth of Injectables Places Unprecedented Demands on Parenteral Manufacturing
Contributor Cindy H. Dubin highlights many of these CDMOs as well as innovations in the PFS sector.
FORMULATION FORUM - Supercritical Carbon Dioxide (scCO2) for Improving Solubility & Oral Bioavailability of Drugs
Shaukat Ali, PhD, and Jim Huang, PhD, discuss as more new chemical entities coming out of discovery are poorly soluble (BCS Class II and IV), the scCO2 is taking an aim to find the desired solutions to help improve the bottleneck in the industry.
TKIS - Next-Generation BCR-ABL TKIs for CML: The Allosteric Era
Emil Kuriakose, MD, explores the current CML treatment landscape, ongoing clinical challenges, and the potential of next-generation TKIs currently in development, offering hope for the growing CML community.
SELF ADMINISTRATION - Smarter, Kinder, Simpler: EcoSafe Sets a New Standard for Sustainable Self-Administration
Mark Glass takes a novel approach to serve a patient group, with the ambitious aims of increasing the inclusivity of its existing 1mL safety syringe, simplifying procurement, reducing cost, and reducing carbon footprint.
EXCIPIENTS - Strategic Excipient Sourcing: Navigating Supply Chain Resilience, Quality & Sustainability by Design
Nick DiFranco, MEM, explores the critical considerations drug developers must evaluate when selecting an excipient partner today.
EXECUTIVE INTERVIEW - Resilience: From Complexity to Clarity - Sharpening Focus for Long-Term Performance in a More Demanding CDMO Era
Catherine Hanley, VP, Head of Marketing and Corporate Communications, explains how the company has rebalanced its network and aligned around its core strengths in biologics and sterile fill/finish manufacturing.
IPSC-NK THERAPIES - Advancing Allogeneic Platforms: The Future of Scalable iPSC-NK Therapies
Stefan Braam, PhD, explores how developers across the industry are tackling these challenges through process optimization, automation, and gene editing innovations. These efforts aim to deliver robust, cost-effective allogeneic platforms that meet the demands of modern healthcare.
EXECUTIVE INTERVIEW - Vetter Pharma: Why Fill-Finish Matters More Than Ever – & the Trends Behind It
Carsten Press, one of Vetter’s Managing Directors, discusses the key trends shaping CDMO innovation in today’s dynamic market – and how the family-owned company is integrating these trends into its forward-looking strategy to support consistent quality and seamless drug delivery.
CAR-T CELLS - The Growing Benefits of CAR-T Cells in Cancer Research & Beyond
Michael Kapinsky, PhD, says successful management or even curing a growing range of severe diseases, often lacking sufficient treatment options, seems to be in reach using CAR-engineered immune cells.
NASAL DELIVERY - Blazing a Trail to Patient-Friendly CNS Therapies: Exploring The Promise, Progress & Challenges of Nose-to-Brain Drug Delivery
Justin Lygrisse explores the rationale behind nose-to-brain delivery and the early clinical and preclinical efforts now underway to assess its potential.
SPECIAL FEATURE - Bioavailability & Solubility: Experimental Techniques Combined With Computational Decision-Making Rapidly ID the Most Viable Enhancement Pathway
Contributor Cindy H. Dubin highlights other ways formulators are relying on automation, such as Artificial Intelligence and Machine Learning, and how these tools are being combined with experimental confirmation to identify the most promising development strategies.
ARTIFICIAL INTELLIGENCE - The AI-Driven Path to Precision Therapeutics
Rotem Gura-Sadovsky, PhD, and Maayan Eilon-Ashkenazy, PhD, explore the potential for AI to transform drug discovery, charting a path towards more targeted precision therapeutics.
BIOAVAILABILITY & SOLUBILITY - Formulation Strategies for Tackling Poor Oral Bioavailability
Richard Johnson, PhD, says better characterization of NCEs in the early stages of development and identifying solubility issues early offers the opportunity to address poor bioavailability using formulation techniques that deliver enhanced drug exposure – reducing risk, conserving resources, and increasing the chances of clinical success.
CML ADVANCES - To Improve Upon a Miracle Drug: Overcoming Drug Resistance & Intolerance in CML
Ben Hohl, says while imatinib and other TKIs have undoubtedly positively impacted the lives of many people living with CML, thousands of patients are still looking for drugs that provide better efficacy, tolerability, and convenience.
COMBINATION PRODUCTS - Early Decisions to De-Risk the Transition to Combination Products
Dr. Mike Ulman says an important part of combination product development is compiling the regulatory submission. Without approval from regulatory bodies, products do not make it into regulated markets.
EXECUTIVE INVTERVIEW - Klotho Neurosciences: Focused on Neurodegenerative & Age-Related Disorders
Dr. Joseph Sinkule, Founder & CEO of Klotho Neurosciences, discusses the company, its therapies, the human Klotho gene, and longevity.
POLYMACROCYCLIC PEPTIDES - Engineering Structure for Function in Next Generation Therapeutics
Karsten Eastman, PhD, and Vahe Bandarian, PhD, believe the key challenge, and opportunity, is to sculpt peptide architecture so that shape and chemistry are presented to the target in the right place, at the right time, and for long enough to matter clinically.
TECHNOLOGY TRANSFER - Streamlining Biologics Technology Transfer Through Integrated Operational Models
Lalit Saxena explains how technology transfer in biologics manufacturing is an inherently complex process that requires the simultaneous control of multiple scientific, technical, and operational variables.
EXECUTIVE INTERVIEW - Lonza: Addressing Solubility Challenges in Early Stages of Drug Development
Adi Kaushal, Director and Technology Head, Bioavailability Enhancement, at Lonza, discusses solubility issues and Lonza’s approach to addressing these challenges in the early stages of drug development.
