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 - 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.
Technical Brief: Mucoadhesive Polymers in Pharmaceutical Formulations
This technical brief will cover the use of polymers in a variety of dosage forms (buccal/sublingual tablets, liquid, semi-solid formulations, and oral care products) to impart mucoadhesion. The basic mechanism of mucoadhesion and methods to evaluate it in the context of…
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
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…
Traws Pharma’s Bird Flu Drug Candidate Presented at ICAR
Traws Pharma, Inc. recently announced that positive data supporting the potential for tivoxavir marboxil (TXM) as a bird flu treatment was presented yesterday in a…
Silexion Therapeutics Announces Completion of Innovative Expanded Development Plan for SIL204
Silexion Therapeutics Corp. recently announced it has completed an expanded development plan for its next-generation siRNA candidate, SIL204, which the company’s management will be presenting…
Wugen Announces Dosing of First Patients in Pivotal Trial of Off-the-Shelf, Allogeneic, CD7-Targeted CAR-T Cell Therapy WU-CART-007
Wugen, Inc. recently announced the dosing of the first patients in its pivotal Phase 2 study evaluating WU-CART-007, a potential first-in-class, investigational, anti-CD7 CAR-T cell…
Evestia Clinical Launches as a Market Leading Pharmaceutical Research Specialist Focused on Clinical Trials in Oncology & Rare Diseases
Evestia Clinical has today been announced as the new identity of EMAS Pharma, as it sets its sights on rapid growth as a provider of…
Esperion Aligns With FDA to Initiate Phase 3 Clinical Trials of Bempedoic Acid in Pediatric Heterozygous & Homozygous Familial Hypercholesterolemia
Esperion recently announced that following meetings with the US FDA, it has gained alignment on a regulatory path forward for initiating Phase 3 studies of…
Indaptus Therapeutics Reports New Data Demonstrating Successful Broad Immune System Activation in Weekly Dosing Trial of Decoy20
Indaptus Therapeutics, Inc. recently provided an update on key pharmacodynamic findings from the weekly dosing cohort of its ongoing Phase 1 trial of Decoy20. As…
Candel Therapeutics & IDEA Pharma Announce Strategic Partnership to Advance Path-to-Market Commercialization Efforts for CAN-2409
Candel Therapeutics, Inc. together with IDEA Pharma, a Division of SAI MedPartners (IDEA) recently announced a strategic commercial partnership. Under this agreement, IDEA will provide…
Second Data Safety Monitoring Board Issues Positive Recommendation to Continue BriaCell’s Phase 3 Study in Metastatic Breast Cancer
BriaCell Therapeutics Corp. recently announced the external Data Safety Monitoring Board (DSMB), an independent group of experts who review and monitor the safety data of…
Dyadic Announces Funding Award to Use C1 to Accelerate Development of Protein-Based Vaccines
Dyadic International, Inc. recently announced it has received a funding award from CEPI to use C1 to accelerate the development of protein-based vaccines. CEPI is…
Longeveron Announces Positive Type B Meeting With FDA Regarding Pathway to BLA for Laromestrocel in Alzheimer’s Disease
Longeveron Inc. recently announced the positive outcome of a Type B meeting with the US FDA, supporting the advancement of laromestrocel (Lomecel-B), a proprietary, scalable,…
Acumen Pharmaceuticals Announces Topline Results From Phase 1 Study of Subcutaneous Formulation of Sabirnetug
Acumen Pharmaceuticals, Inc. recently announced topline results from its Phase 1 study comparing pharmacokinetics (PK) between subcutaneous (SC) and intravenous (IV) formulations of sabirnetug in healthy…
Conduit Pharmaceuticals Provides R&D Update on Progress for Pipeline Assets
Conduit Pharmaceuticals Inc. recently provided an R&D update on the development progress of pipeline assets AZD1656, AZD5658, and AZD5904. The Company has made significant progress…
Genenta Announces $21.9M Financing to Expand Pipeline as Brain Tumor Trial is Showing Promising Survival Rates
Genenta Science recently announced a $21.9 million financing through the issuance of a Mandatory Convertible Bond to ENEA Tech and Biomedical (ETB) to support the expansion…
Tract Bio Announces Publication in Gastroenterology Potential Targets for Esophageal Adenocarcinoma Identified Using stemECHOTM Cloning Platform
Tract Bio recently announced the publication of preclinical research in Gastroenterology. The article, “Evolution of Esophageal Adenocarcinoma from Precursor Lesion Stem Cells” describes results from…
Curevo Raises $110 Million to Advance Amezosvatein Shingles Vaccine
Curevo Vaccine recently announced the closing of a $110-million Series B round to advance development of amezosvatein, its vaccine for shingles. Leading the round is…
llarity Therapeutics Announces Presentation of Phase 2 Clinical Data from Ongoing Trial in Advanced Ovarian Cancer Patients
Allarity Therapeutics, Inc. announced the presentation of new clinical data from its ongoing Phase 2 trial with stenoparib monotherapy in advanced Ovarian Cancer at the…
Curia Announces Expansions to Global Network of Sterile Fill-Finish Sites
Curia Global, Inc. recently announced expansion plans to its Glasgow, UK, facility and provided updates on the ongoing expansion in Albuquerque, NM. Curia’s sterile fill-finish…
GRIN Therapeutics Receives FDA Orphan Drug Designation for Treatment of GRIN-Related Neurodevelopmental Disorder Treatment
GRIN Therapeutics, Inc. recently announced the US FDA granted Orphan Drug designation for its investigational drug, radiprodil, for the treatment of GRIN-related neurodevelopmental disorder (NDD).…
Cellphire Therapeutics CLPH-511 Fast Track Designation Granted
Cellphire Therapeutics, Inc. recntly announced the US FDA has granted Fast Track designation for CLPH-511 (Frozen Activated Platelets) Injectable Suspension for the treatment of acute…
