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.
CLINICAL TRIALS - Need for Accessibility to Meet FDA Guidance for Decentralized Trials
Neil Vivian believes advances in electronic data collection and analysis are helping to make DCTs more accessible to broader and more diverse patient populations. Further innovations, particularly in artificial intelligence technology, are expected to accelerate these trends.
On-Demand Presentation: High Concentration Protein Suspensions: A Bevacizumab Case Study (>400 mg/mL)
Dr. Cindy Chung presents a case study demonstrating the development of high concentration bevacizumab suspension at up to 400 mg/mL for suitable subcutaneous delivery of the monoclonal antibody (mAb) therapy. Watch the presentation now to learn more.
DRUG-DEVICE DEVELOPMENT - Exploring the Complexities of Drug-Device Combination Products
Jeremy Guo, Senior Vice President at WuXi Biologics, and colleagues explain that many factors need to be taken into account when producing a Drug-Device Combination Product from development testing to fill/finish and assembly.
CPHI Annual Report 2024: Drug Delivery Trends & Insights From a Device Perspective
Significant growth in the drug delivery sector is predicted for many areas, with headliners including cell and gene therapies and the GLP-1 blockbusters. Small molecule-based formulations still dominate innovator pipelines, but advanced biologics are also….
Gelteq: A Breakthrough Ingestible Gel Drug & Nutrient Delivery System
Drug Development & Delivery recently interviewed Nathan Givoni, Co-Founder and CEO of Gelteq, to discuss challenges with traditional drug delivery and the company’s innovative ingestible gel platform designed for drug and nutrient delivery.
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EXCLUSIVE WHITEPAPERS
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…
WHITEPAPER - Unlock the Secrets of Spray Drying for Sticky APIs
It is widely reported that 40% of New Chemical Entities (NCEs) in the pharmaceutical industry are poorly soluble, leading to inadequate bioavailablity. Spray drying is one of the most promising particle engineering technologies….
EXCLUSIVE WEBINARS
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.
WEBINAR - 2024 Trends in Topical Drug Delivery: Insights & Innovation
This webinar will discuss some of the key trends from these leaders in the topical market on both a global and regional level, including the increased importance of sensory properties and the rise in non-conventional product formats, among others…..
MARKET NEWS & TRENDS
Medigene AG Expands Patent Portfolio With Patent Grant for its JOVI Technology in the US
Medigene AG recently announced it has been issued a patent by the US Patent Office protecting its JOVI technology, a method allowing the enrichment of…
IMUNON Announces Translational Data from Phase 1/2 OVATION 2 Study of IMNN-001 in Advanced Ovarian Cancer
IMUNON, Inc. recently announced new translational data from ongoing analyses of results from the Company’s Phase 2 OVATION 2 Study of IMNN-001, its investigational interleukin-12 (IL-12)…
Atrandi Biosciences Raises $25M Series A Led by Lux Capital to Drive the Future of Single-Cell Multiomics with Semi-Permeable Capsule Technology
Atrandi Biosciences recently announced a $25 million Series A funding round led by Lux Capital, with participation from Vsquared Ventures, Practica Capital, Metaplanet and GRIDS Capital.…
Silo Pharma Expands Intellectual Property Portfolio With Provisional Patent
Silo Pharma, Inc. recently announced the filing of a provisional patent application with the U.S. Patent and Trademark Office (USPTO) for its lead asset SPC-15.…
Artelo Biosciences Announces New Data on ART12.11 Tablets Showing Improved Pharmacokinetics to Epidiolex
Artelo Biosciences, Inc. recently announced nonclinical results on ART12.11, its proprietary cocrystal composition of cannabidiol (CBD) and tetramethylpyrazine (TMP). The findings were presented by Professor Saoirse…
IN8bio Presents Positive Phase 1 Data Highlighting Durability of Remissions in High-Risk AML
IN8bio, Inc. recently presented Phase 1 data on its allogeneic gamma-delta T cell therapy, INB-100, at the 2025 Transplantation & Cellular Therapy (TCT) Meetings in…
Bicara Therapeutics Announces First Patients Enrolled in FORTIFI-HN01, a Pivotal Phase 2/3 Clinical Trial of Ficerafusp Alfa in 1L Recurrent/Metastatic Head & Neck Squamous Cell Carcinoma
Bicara Therapeutics Inc. recently announced the first patients have been enrolled in FORTIFI-HN01, a pivotal Phase 2/3 trial of ficerafusp alfa in combination with pembrolizumab…
Abcuro Announces $200 Million Financing to Advance its First-In-Class Medicine in Development for Inclusion Body Myositis
Abcuro, Inc. recently announced the closing of a $200-million Series C financing led by New Enterprise Associates (NEA) with Foresite Capital joining the round and…
Mangoceuticals Advances Antiviral Research on its Patented Respiratory Illness Prevention Technology
Mangoceuticals, Inc. recenntly announced it is advancing its research into respiratory illness prevention technologies by focusing on finding a practical, everyday solution to combat avian…
MediWound Initiates the VALUE Global Phase 3 Pivotal Trial of EscharEx for Treatment of Venous Leg Ulcers
MediWound Ltd. recently announced the initiation of VALUE, a global, pivotal Phase 3 trial evaluating EscharEx for the treatment of venous leg ulcers (VLUs). “We…
Silo Pharma Announces Positive Initial Pharmacokinetic, Safety & Tolerability Study of SP-26 for Chronic Pain and Fibromyalgia
Silo Pharma, Inc. recently announced a positive update from an ongoing study evaluating the pharmacokinetics, safety and tolerability of its novel SP-26 ketamine extended-release rods…
Ocean Biomedical Announces Breakthrough Findings in EGFR-Mutant Lung Cancer & Plans for FDA Alignment on Next-Stage Development
Ocean Biomedical recently announced newly published research findings demonstrating the ability of its proprietary cancer immunotherapy candidates to favorably interact with tyrosine kinase inhibitors (TKI),…
Safi Biotherapeutics & ARMI BioFabUSA Initiate Collaboration to Support Large-Scale Development of mRBCs
Safi Biotherapeutics recently announced a collaboration focused on the manufacturing of Safi’s mRBCs to support regulatory requirements and initial clinical studies. “We are very excited…
Biodexa Receives US FDA Fast Track Designation for eRapa in Familial Adenomatous Polyposis
Biodexa Pharmaceuticals PLC recently announced the US FDA has granted Fast Track designation for eRapa, a proprietary encapsulated form of rapamycin being developed for the…
Recipharm Expands Aseptic Filling Capabilities for Process Development, Pilot Scale & Clinical Supply
Recipharm recently announced a new modular sterile filling system specifically tailored for process development, pilot scale and clinical supply, is now fully operational at its…
Alumis & ACELYRIN to Merge Creating a Late-Stage Clinical Biopharma Company
Alumis Inc. and ACELYRIN, INC. recently announced a definitive merger agreement under which Alumis and ACELYRIN will merge in an all-stock transaction. Martin Babler, President,…
Conduit Pharmaceuticals Transitions to Phase 2 of Sarborg Collaboration to Support AI-Driven Drug Development
Conduit Pharmaceuticals Inc. recently announced the successful completion of all milestones in Phase 1 of its strategic collaboration with Sarborg Limited. This transition to Phase…
Maze Therapeutics Doses First Patient in Phase 2 Trial Evaluating MZE829 as a Potential Treatment for APOL1 Kidney Disease
Maze Therapeutics, Inc. recently announced the first patient has been dosed in the company’s Phase 2 clinical trial, the HORIZON Study, of MZE829 in patients…
Thermo Fisher Scientific Launches International CorEvitas Clinical Registry in Adolescent Alopecia Areata
Thermo Fisher Scientific Inc. recently announced the launch of the international CorEvitas Adolescent Alopecia Areata (AA) Registry, addressing a critical unmet need for real-world, adolescent-specific…
Gradalis Secures FDA Regenerative Medicine Advanced Therapy Designation for Investigational Personalized Immunotherapy for Advanced Ovarian Cancer
Gradalis, Inc. recently announced the US FDA has granted Gradalis’ personalized investigational cellular immunotherapy, Vigil (Gemogenovatucel-T) Regenerative Medicine Advanced Therapy (RMAT) designation based on favorable clinical…
