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.
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.
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….
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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
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…
Steritas Announces Collaboration With argenx to Advance Evidence for Novel Steroid-Sparing Therapeutics
Steritas LLC recently announced a licensing agreement with argenx, a global immunology company, for use of its STOX Suite of steroid-toxicity clinical outcome assessments (COAs)…
GeoVax Announces Positive Interim Data Review for Phase 2 Clinical Trial of COVID-19 Vaccine Booster in Patients With Chronic Lymphocytic Leukemia
GeoVax Labs, Inc. recently announced the completion of an interim data review by the Data Safety Monitoring Board (DSMB) for the ongoing Phase 2 clinical…
HCW Biologics & WY Biotech Announce License Agreement for Immunotherapeutic Product Candidate
HCW Biologics Inc. and WY Biotech Co., Ltd. recently announced they have entered into a worldwide exclusive license agreement to develop and commercialize one of…
Trogenix Unveils Revolutionary Platform to Transform Cancer Treatment Through Precision Viral Immunotherapy
Trogenix Ltd emerged from stealth mode to unveil its groundbreaking therapeutic platform for treating aggressive cancers. Built from inception by 4BIO Capital, which specializes in…
MBX Biosciences Announces Last Subject Last Visit in Phase 1 Trial of MBX 1416 for the Treatment of Post-Bariatric Hypoglycemia
MBX Biosciences, Inc. recently announced the completion of the last subject’s last visit in its Phase 1 single and multiple ascending dose trial of MBX…
EnteroBiotix Completes Phase 2 Study Recruitment of EBX-102-02 IBS
EnteroBiotix Limited recently announced the completion of recruitment in its Phase 2 TrIuMPH (Treating IBS with an Intestinal Microbiota Product for Health) trial assessing the…
Bluejay Therapeutics Reports Best-in-Class Monoclonal Antibody Achieved 100% Virologic Response & Up To 78% Combined Virologic Response, & ALT Normalization as Monotherapy in Participants With Chronic Hepatitis D
Bluejay Therapeutics recently announced new data from its Phase 2 study of BJT-778, a best-in-class investigational, fully human, high-affinity monoclonal antibody (mAb) that targets hepatitis…
Quotient Sciences Announces Installation of World's First GMP Biofoundry-in-a-Box From Centillion Technology
Quotient Sciences recently announced the installation of Centillion’s proprietary Biofoundry-in-a-Box (BiaB), the first multi-product GMP platform technology for end to end RNA manufacture. BiaB is…
AlveoGene Receives Rare Pediatric Disease Designation Novel, Inhaled Gene Therapy for Lethal Neonatal Surfactant Protein B Deficiency
AlveoGene recently announced it has been granted a Rare Pediatric Disease Designation (RPDD) by the US FDA for AVG-002, its novel, inhaled gene therapy for…
