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.
EXPERT CONTENT & RESOURCES
Whether you're a researcher, a pharmaceutical professional, or simply interested in the latest advancements in drug development and delivery technology, you'll find a wealth of insightful expertise and current resources here.
How to Choose the Right CDMO for Your Pharmaceutical Project
This guide outlines the fundamental considerations to ensure your CDMO selection aligns with your project goals.
Understanding the Foundation of LNP Formulation Success
Download our eBook and discover everything you need to know about lipids for developing LNP therapies, including:….
Lyophilization Development: Quality by Design Approach
Lyophilization, or freeze-drying, addresses stability challenges associated with complex APIs, biologics, microbiomes, gene therapies, viral vectors, liposomes, and nanoparticles……
Choosing the Right Particle for Your Nanomedicine Application
Nanoparticles are revolutionizing the landscape of nanomedicine, enabling significant advancements in early detection, targeted drug delivery, disease monitoring, and imaging. Due to their nanoscale size, these particles….
Join us for the inaugural Quotient Sciences Capability Expo, hosted at our state-of-the-art Garnet Valley facility.
This unique event offers a behind-the-scenes look at how we support molecules from preclinical stages through to commercial manufacturing…..
Have expert content to share? Contact us
EXCLUSIVE WHITEPAPERS
WHITEPAPER - 3D SCREEN Printing: Enabling a New Generation of Complex Formulations
By overcoming key challenges 3D screen printing is unlocking new possibilities in drug development and manufacturing.
WHITEPAPER - Formulating Custom Viscosity Blends With POLYOX™ Polyethylene Oxide
Excipient variability plays a critical role in pharmaceutical product design. A risk-based, scientific approach to Quality by Design (QbD) is essential to ensure consistent drug…
CASE STUDY - Overcoming Barriers to Patient Adherence With A Novel Dosage Form
In this CPHI Award-winning case study, learn how Adare scientists took the alternative sprinkle version out of the lab and into the hands of patients.
ARTICLE - A New Framework for Identifying Nitrosamine Risks & Efficiently Derisking Products
Adare’s team of nitrosamine experts have developed a straightforward framework that simplifies the identification of at-risk APIs.
WHITEPAPER - Concept to Commercialization: The Role of CDMOs in Driving Innovation Through Phase-Appropriate Technology Transfers
This whitepaper explores the various types of technology transfer from preclinical to commercial stages and successful strategies to foster innovation.
EXCLUSIVE WEBINARS
WEBINAR ON DEMAND: Precision at Scale: Enabling Novel Therapeutics With Nanoparticle Manufacturing
Watch this on-demand webinar to learn about the key steps and considerations in bringing novel nanoparticle-based therapeutics from early R&D to commercial stages. Drawing from our 20 years of experience in the CDMO space, we cover critical topics unique to nanomaterials…..
WEBINAR: Introducing Key Concepts in Tableting Research: Unleashing Essential Concepts and Strategies for Enhanced Formulation Development
Tableting can present a series of challenges, particularly when dealing with formulations that have poor flowability, low compressibility, or high cohesivity. These issues can lead to manufacturing inefficiencies….
WEBINAR ON DEMAND: Advantages of Carbopol® Polymers in Oral Formulations
In this video, the Lubrizol team together with the IMCD US team takes you through formulation aspects of Carbopol® polymers as well as the results of a case study on an Acetaminophen oral suspension formulation.
WEBINAR - ABISOL Emulsion Preconcentrate Kit & ABISORB-DC Excipient System for Tableting Lipids
ABITEC Technical Business Director, John Tillotson, RPh, PhD, discusses ABITEC’s latest products: The ABISOL Emulsion Preconcentrate kit for the easy formulation of emulsified drug delivery systems and the….
WEBINAR - Development of Orally Delivered GLP-1 Therapeutics…From Diabetes to Obesity and Beyond
Join Quotient Sciences’ experts on July 18 as we explore the latest developments in orally-delivered GLP-1 agonists, the potential for these therapeutics and overcoming the manufacturing challenges.
MARKET NEWS & TRENDS
Regulus Therapeutics Announces Successful Completion of its Phase 1b MAD Clinical Trial for Autosomal Dominant Polycystic Kidney Disease Treatment
Regulus Therapeutics Inc. recently announced positive topline results from all patients in the fourth cohort in its Phase 1b MAD study of farabursen for the treatment…
Gyre Therapeutics Announces Publication of Protocol for Phase 3 Trial Evaluating F351 for CHB-Associated Liver Fibrosis
Gyre Therapeutics recently announced the publication of the manuscript titled Hydronidone for the Treatment of Liver Fibrosis Associated with Chronic Hepatitis B: Protocol for a…
Galatea Bio Secures $25M to Develop Global Biobank & Enable Precision Health at Scale for All
Galatea Bio has secured $25 million in funding to drive discoveries in next-generation genetic analysis, biomarker discovery, and multi-omics disease modeling. Committed to enabling precision health…
NeOnc Technologies Expands Global Clinical Trial Network With CBCC Global Research to Accelerate Study of Brain Cancer Treatments
NeOnc Technologies Holdings, Inc. recently announced a strategic partnership with CBCC Global Research (CBCC), a premier full-service clinical research organization (CRO). This collaboration will expand NeOnc’s…
CERo Therapeutics Holdings Poised to Initiate Enrollment of Phase 1 Trial of CER-1236 in AML Following Positive FDA Review of Manufacturing
CERo Therapeutics Holdings, Inc. recently announced that the company has received positive review from the US FDA on an amendment to its IND around Chemistry,…
Polyrizon Structures Clinical Strategy for its Allergy Blocker Ahead of FDA Pre-Submission Meeting
Polyrizon Ltd. recenytly announced the structuring of its clinical strategy for PL-14, the company’s proprietary intranasal allergy blocker for seasonal allergic rhinitis. The clinical strategy…
Salarius Pharmaceuticals Merger Partner, Decoy Therapeutics, Announces its Novel Inhibitors Show Promising In Silico Activity Against Measles & Related Viruses
Decoy Therapeutics Inc. recently announced a series of antiviral drug candidates previously designed by its IMP3ACT™ platform to be broadly effective against viruses of the…
Acumen Pharmaceuticals Completes Enrollment of Phase 2 Clinical Trial of Sabirnetug in Early Alzheimer’s Disease
Acumen Pharmaceuticals, Inc. recently announced the completion of enrollment in its ALTITUDE-AD Phase 2 trial of sabirnetug (ACU193) in patients with early Alzheimer’s disease. Acumen completed…
Bluejay Therapeutics Announces First Patient Dosed in AZURE-1 Global Pivotal Clinical Trial Evaluating Brelovitug as a Monotherapy Treatment for Chronic Hepatitis D
Bluejay Therapeutics recently announced the first patient has been dosed in its AZURE-1 global pivotal clinical trial evaluating brelovitug (also known as BJT-778) for the…
Silo Pharma Achieves Key Milestone With First Dosing in IND-Enabling GLP Study for SPC-15 as a Groundbreaking PTSD Treatment
Silo Pharma, Inc. recently announced first dosing in an investigational new drug (IND)-enabling GLP (Good Laboratory Practice)-compliant toxicology and toxicokinetics study of its lead asset,…
Enable Injections Announces Regulatory CE Mark Approval in Europe for enFuse Technology
Enable Injections, Inc. recently announced it has received its European Union Medical Device Regulation (EU MDR) CE Mark approval of the enFuse Syringe Transfer System. This…
Nanoscope Announces Publication of Clinical Data on Vision Restoration in Retinitis Pigmentosa
Researchers with Nanoscope Therapeutics Inc. recently announced the publication of a paper, A synthetic opsin restores vision in patients with severe retinal degeneration, in Molecular…
Porosome Therapeutics Unveils Groundbreaking Discovery in Alzheimer’s Disease Research & Treatment
Porosome Therapeutics, Inc. recently announced its latest development in identifying the secretory dysfunction responsible for Alzheimer’s Disease along with advancements in therapeutic neuronal nanomachines. These innovations…
First Patient Dosed in Immutep’s TACTI-004 Phase 3 Trial in First Line Non-Small Cell Lung Cancer
Immutep Limited recently announced the first patient has been successfully dosed in the Company’s pivotal TACTI-004 Phase 3 trial. TACTI-004 will evaluate Immutep’s eftilagimod alfa,…
Tiziana Life Sciences Announces Yale University Commences Intranasal Foralumab Dosing in Phase 2 Multiple Sclerosis Trial
Tiziana Life Sciences, Ltd. recently announced dosing of new patients at Yale MS Center, which is participating in our multicenter Phase 2 clinical trial evaluating…
Character Biosciences Raises $93 Million to Advance Precision Medicine for Progressive Eye Diseases
Character Biosciences recently announced an oversubscribed $93 million Series B financing round to accelerate the advancement of its pipeline of precision therapies to treat degenerative…
IMUNON Finalizes Phase 3 Study Design With FDA for IMNN-001 in Newly Diagnosed Advanced Ovarian Cancer
IMUNON, Inc. recently announced the US FDA is aligned with the protocol for the Phase 3 pivotal trial, called OVATION 3, of its lead candidate…
Journey Medical Corporation Launches Emrosi (40-mg Minocycline Hydrochloride Modified-Release Capsules, 10-mg Immediate Release & 30- mg Extended Release) for the Treatment of Rosacea
Journey Medical Corporation recently announced the launch of and the first prescriptions filled for Emrosi (40-mg Minocycline Hydrochloride Modified-Release Capsules, 10-mg immediate release and 30-mg…
Tenaya Therapeutics Publishes Preclinical Data Demonstrating TN-201 Enhances Cardiac Function & Survival in MYBPC3 Cardiomyopathy Models
Tenaya Therapeutics, Inc. recently announced the publications of positive preclinical data for TN-201, the company’s gene therapy candidate for Myosin-Binding Protein C3 (MYBPC3)-associated hypertrophic cardiomyopathy…
Upperton Pharma Solutions Wins Champion Award at 2025 CDMO Leadership Awards in Small Molecule Dosage Form Category
Upperton Pharma Solutions is proud to announce its selection as Champion Winner in the Small Molecule Dosage Form – International category at the 2025 CDMO…
