DRUG DELIVERY - Advancements in Transdermal Delivery Systems: A Focus on Invisicare® Technology for Obesity Treatment
James A. Roszell, PhD, and Doreen McMorran demonstrate how this technology has demonstrated potential in the transdermal administration of glucagon-like peptide-1 (GLP-1) agonists and cannabinoid receptor type 1 (CB-1) antagonists, primarily targeting obesity management and other conditions requiring glucose regulation.
FORMULATION FORUM - Lyophilization Technology - An Enabler for Stable Formulations of Small & Large Molecules
Shaukat Ali, PhD, and Jim Huang, PhD, explain how lyophilization or freeze-drying technology is one of the ideal methods that leads to immobilization of drug and other components that remain in solid or powder state for extended periods without concerns of degradation, and how it has also been applied to improve drug solubility by means of amorphous solid dispersions.
ARTIFICIAL INTELLIGENCE - Deciding Whether to Automate With AI? 6 Key Practices to Consider
Dan Milczarski believes before deciding if or how to use AI in life sciences, it’s critical to weigh the pros and cons. There is a vital need to customize constantly evolving AI applications and innovations to create tailored, effective technologies that reflect life science organizations’ regulatory and organizational frameworks.
THERAPEUTIC FOCUS - Pushing Boundaries in Idiopathic Pulmonary Fibrosis Clinical Research
Laura Iliescu, MSc, and Justin Herman, MD, explore the changing landscape of IPF and how biopharmaceutical companies developing novel treatments can effectively navigate the emerging challenges in a rapidly evolving IPF landscape.
CONTROLLED RELEASE - How Advanced Excipient Knowledge is Shaping the Future of Controlled-Release Formulations
Matthias Knarr, PhD, and True Rogers, PhD, review the latest insights behind CR formulations using HPMC excipients and how HPMC substitution specifically can assist formulators in developing cutting-edge CR delivery systems with differentiated performance.
EXECUTIVE INTERVIEW - Respiratory Drug Development: Lonza Experts Share Trends & Key Takeaways
Beatriz Fernandes, Principal Scientist for R&D, and Kim Shepard, Director, Technology Head Respiratory Delivery, at Lonza, discuss their presentations at RDD 2024, current trends, and the future of the inhalation space.
TOPICAL DELIVERY - Direct Effects™ Perampanel (FYCOMPA®): First Topical Anticonvulsant to Treat Seizures, Headache & Other Symptoms in Epilepsy
Ronald Aung-Din, MD, Sasha Feygin, and Daniele La Rosa say Direct Effects topical perampanel is effective in treating headache and other neurological symptoms commonly encountered in patients with seizures and other conditions in which neuronal instability and hyper-excitability exist.
LYOPHILIZATION - Lyo 101: Challenges & Solutions in Lyophilization Cycle Development
Matt Bourassa says as companies continue to pioneer new molecules and treatments, molecule stability has emerged as a persistent detriment to every iteration, and increasingly, lyophilization is an attractive path to a sustainable, repeatable solution.
FORMULATION DEVELOPMENT - Practical & Purposeful: Creating Novel Compounds Via Rediscovery R&D & Cannabinoid Molecules
Mark Bleackley, PhD, says as time goes on, more companies will discover the benefits of drug repurposing – and how to successfully use such strategies to develop new, patentable drug products. In fact, repurposing could be exactly what’s needed to enable pharmaceutical and biotechnology companies to more swiftly develop treatments for indications with significant unmet medical needs.
SMI TECHNOLOGY - How Soft Mist Inhalers Support Improved Biopharma Drug Delivery
Nicolas Buchmann, PhD, explores the opportunities and challenges of developing biologic formulations for delivery via SMIs and discusses the importance and impact of partnerships between inhalation device development experts when it comes to facilitating the innovation needed to expand the suitability of SMIs to a wider range of biopharma formulations.
PRECLINICAL/CLINICAL STUDIES - Preclinical Toxicology vs Clinical: Key Considerations in Using Lipid-Based Formulations
Anette Müllertz, PhD, Grace Furman, PhD, and Lisa Caralli say developers should first understand the developability challenges for their molecule, then a toolkit of enabling technologies can be identified to overcome those factors and individually leveraged to create fit for purpose formulations for use in preclinical and clinical studies.
PLATFORM TECHNOLOGY - Developing Novel Antisense Oligonucleotides for Neurodegenerative Diseases
Scott Schobel, MD, and Nicole Datson, PhD, are hopeful their novel platform for targeting disease-causing RNA with multiple modulating approaches will lead to major advances in treating genetic disease and improving the lives of patients and their families in the years ahead.
SPECIAL FEATURE - Injection Devices: From Pens & Autoinjectors to Pills, Sprays & Capsules, Injections Become More Efficient
Contributor Cindy H. Dubin reports on innovative and promising injection technologies that are ever more user friendly, versatile, precise, and life-saving.
ARTIFICIAL INTELLIGENCE - Accelerating Drug Discovery & Development: The AI Revolution is Here
Emilio Cordova delves into how AI is transforming the drug discovery sector by enhancing predictability and efficiency and explains her company’s unique approach.
FORMULATION DEVELOPMENT - Solubility-Enhancing Technologies in Pharmaceutical Development, a Mini-Review
Timothy Pas, PhD, and Vincent Levet, PhD, believe different solubility-enhancing technologies can be used by developers, and with different advantages and drawbacks, linked to payload, manufacturability, tolerability, and physical and chemical stability, effectively navigating solubility-enhancing solutions is multifaceted.
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.
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.
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.
Lonza: Utilizing Analytical Tools & Predictive Models to De-Risk Drug Development
Drug Development & Delivery recently interviewed Josh Marsh, Bioavailability Enhancement and PBPK Lead Scientist at Lonza, to discuss the benefits of predictive tools and Lonza’s approach.
MediWound Ltd.: Developing a New Class of Biologic Enzymatic Therapeutic Products to Debride Wounds
Drug Development & Delivery recently interviewed Ofer Gonen, Chief Executive Officer of MediWound, to discuss the company’s innovative approach to debridement.
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EXCLUSIVE WHITEPAPERS
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….
WHITEPAPER - Versatility of Geleol™ Mono- and Diglycerides NF
Geleol exerts different functional roles, depending on the drug, formulation, and the process applied. It may serve as carrier and release modifier for oral formulations and plasticizer in tablet film coating processes. It may be combined with polymers and/or other non-digestible lipids like Compritol®….
WHITEPAPER - Efficient Development of Miniature Drug-Loaded Implants
Drug-eluting implants offer a unique approach to overcoming challenges associated with traditional drug delivery methods. They can provide sustained, continuous release of a therapeutic at…
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 - Lipid Nanoparticle (LNP) Characterization: Leveraging HPLC-CAD for Lipid Quantification Assay
Whether you’re involved in research, development, or quality control, this webinar will equip you with the knowledge and tools you need to enhance your analytical processes and ensure success in your LNP projects.
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
OncoVerity Secures Extended Series A to Advance Cusatuzumab in Newly Diagnosed AML
OncoVerity recently announced the closing of a Series A extension financing led by existing investors, argenx and RefinedScience. With this funding, OncoVerity aims to advance…
Bormioli Pharma Invents The Open & Collaborative Innovation Platform for the Pharmaceutical Packaging of the Future
Bormioli Pharma, a global leader in the production of containers for pharmaceutical use and medical devices, has always been a promoter of innovation, which translates…
Lipella Pharmaceuticals Announces Completion of First Cohort in Phase 2a Trial of LP-310 for Oral Lichen Planus, Advancing to Next Dose Group
Lipella Pharmaceuticals Inc. recently announced the completion of dosing for the first cohort in its multi-center Phase 2a clinical trial of LP-310, a liposomal-tacrolimus oral…
UMDF & Khondrion Announce The Mito Fund’s Investment in Khondrion to Support Development of One of the Most Advanced Drug Candidates for Primary Mitochondrial Disease
The United Mitochondrial Disease Foundation’s (UMDF) venture philanthropy arm, The Mito Fund, has invested in Khondrion, a Netherlands-based clinical stage biopharmaceutical company discovering and developing therapies…
BriaCell Announces First Patient Dosed With Bria-OTS in Metastatic Breast Cancer Study
BriaCell Therapeutics Corp. recently announced the first patient was dosed in its Phase 1/2 study (ClinicalTrials.gov identifier: NCT06471673) to evaluate the safety and efficacy of…
Dyadic Receives $3 Million Grant to Develop Cost-Effective Monoclonal Antibodies for RSV & Malaria Using C1 Platform Technology
Dyadic International, Inc. recently announced it has been awarded a $3 million grant from the Gates Foundation for the cell line development of monoclonal antibodies…
Vetter Strengthens Senior Management Team for Further Sustainable Growth
Vetter recently announced the appointment of three senior leaders to take on the role of managing directors alongside Thomas Otto and Peter Soelkner. As of…
GRI Bio Showcases GRI-0621’s Potential to Reduce Inflammation, Type 1 Cytokines & Reduce Hepatic Fibrosis in Idiopathic Pulmonary Fibrosis
GRI Bio, Inc. recently announced the presentation of positive preclinical data demonstrating its lead program GRI-0621 reduces important inflammatory and fibrotic drivers in Idiopathic Pulmonary…
Eradivir’s Therapeutic Proven to Reduce Advanced-Stage Influenza Viral Loads Faster, More Thoroughly in Preclinical Studies Than Current Therapies
Eradivir has developed a patent-pending antiviral therapeutic that reduces lung viral loads of advanced-stage influenza in preclinical studies quicker and more effectively than currently available…
Abzena Expands Analytical Capabilities to Include GMP Cell-Based Potency Testing Across US & UK Sites
Abzena recently announced the expansion of their early and late phase analytical capabilities to now include GMP cell-based potency assays at their Cambridge, UK and San…
Lonza Announces First GMP Batch Completion at Next-Generation Mammalian Manufacturing Facility in Portsmouth (US)
Lonza, a global development and manufacturing partner to the pharmaceutical, biotech and nutraceutical markets, today announced the completion of the first GMP product batch supported…
Verge Genomics Announces Milestones in Collaboration With Lilly to Discover & Develop Novel Treatments for ALS
Verge Genomics recently announced Eli Lilly & Company has opted to pursue the development of therapeutics against two validated drug targets for amyotrophic lateral sclerosis…
Voyager Selects Tau Silencing Gene Therapy Development Candidate for Alzheimer’s Disease
Voyager Therapeutics, Inc. recently announced it has selected a lead development candidate, VY1706, for its tau silencing gene therapy program in Alzheimer’s disease. The company…
ImmuneSensor Therapeutics Receives Orphan Drug and Rare Pediatric Disease Designations for Aicardi Goutières Syndrome Treatment
ImmuneSensor Therapeutics recently announced the US FDA has granted both Orphan Drug Designation (ODD) and Rare Pediatric Disease Designation (RPDD) for the company’s lead anti-inflammatory…
Genezen Appoints New Chief Operations Officer
Genezen recently announced the appointment of Mike Wourms as Chief Operations Officer. This appointment bolsters Genezen’s strategic growth plan and comes at a time of…
PCI Pharma Services & ChiRhoClin Partner to Prevent Shortage of Critical Orphan Pancreatic Drug
PCI Pharma Services (PCI) is collaborating with theranostics specialist ChiRhoClin, Inc. to avoid the potential shortage of a critical diagnostic drug used to test for…
Theolytics Doses First Patient in Phase 1/2a Trial of THEO-260 in Ovarian Cancer
Theolytics has dosed the first patient in its Phase 1/2a multi-centre, open-label first-in-human trial (OCTOPOD - NCT06618235) of THEO-260 in patients with advanced-stage platinum-resistant ovarian…
Ardena’s New State-of-the-Art Nanomedicine Facility Secures Full GMP Approval for Manufacturing
Ardena recently announces the full Good Manufacturing Practice (GMP) approval of its expanded nanomedicine facility in Oss. Granted by the Dutch Healthcare Authority, the approval enables…
Biolojic Design Joins Johnson & Johnson Innovation - JLABS
Biolojic Design recently announced it is joining the Johnson & Johnson Innovation – JLABS (JLABS) site in Washington, D.C. As part of JLABS @ Washington,…
Gattefossé Announces Inauguration of its New Premises & Technical Center of Excellence in Mumbai
India is a strategic country for the business development of the Gattefossé Group. To support this growing market, Gattefossé continues to invest in the opening…
