SPECIAL FEATURE - Injection Devices: Faster, Integrated, and Flexible for the IV to SC Transition
Contributor Cindy H. Dubin speaks with several companies who highlight how device developers are addressing various challenges while still ensuring precise dosage control and patient compliance.
SUBCUTANEOUS INJECTIONS - A New Dimension for an Enhanced Injection Experience
Enrico Barichello and Crystal Salvans explore the impact of market trends, focusing on the technical and clinical challenges associated with delivering large-volume, high-viscosity subcutaneous injections. They also highlight the need for optimized delivery systems that can accommodate these formulations without compromising usability or efficacy, as well as the potential advantages such systems may offer for non-viscous injections.
FORMULATION FORUM - Hot Melt Extrusion – An Enabling Technology for Poorly Soluble Drugs
Jim Huang, PhD, and Shaukat Ali, PhD, say in spite of many challenges, drug manufactures continue to look for non-conventional, and often novel, polymers to expedite the development of innovative molecules coming out of discovery when none of the conventional technologies do not meet the desired objectives.
PULMONARY DELIVERY - Development of Pulmonary Dosage Forms for the Successful Delivery of Complex Molecules
Richard Johnson, PhD, believes there is growing interest in next-generation pulmonary delivery devices that can overcome delivering drugs more efficiently into the deep lung and also delivering thermally sensitive drugs that are unstable in solution.
EXECUTIVE INTERVIEW - Lonza & Ethris: Advancing mRNA Vaccines: Room-Temperature Stable, Spray-Dried Formulations for Enhanced Mucosal Delivery
Kim Shepard, Director of Advanced Drug Delivery at Lonza, and Carsten Rudolph, PhD, Co-founder and Chief Executive Officer at Ethris, discuss the main objectives of the collaboration and the benefits of spray-dried mRNA vaccines.
EXECUTIVE INTERVIEW - ALZpath: A Diagnostic Assay Changing the Future of Alzheimer’s Disease
Jacob Hunter, Chief Business Officer, ALZpath, Inc., discusses the development and deployment of the company’s proprietary pTau217 antibody, bridging the gap between detection and treatment to improve patient outcomes globally.
FORMULATION DEVELOPMENT - Innovative Drug Delivery Approaches for GLP-1 Agonists: Enhancing Medication Adherence & Treatment Outcomes
Nasrin Mahmoudi, PharmD, PhD, and Michael Baumann, highlight recent developments in GLP-1 agonist formulations and delivery methods, including advanced injectable formulations, novel oral delivery systems, and topical formulations.
STERILE INJECTABLE MANUFACTURING - Solving Complexity & Strategies for Commercial Success
Jennifer Gattari explores the key forces driving change in the SI space and outlines the core considerations manufacturers must address to deliver safe, effective therapies at commercial scale and the growing reliance on contract manufacturers to help navigate complexity with confidence.
LIPID SOURCING & SELECTION - Navigating the Lipid Landscape: Overcoming the Challenges of Lipid Sourcing & Selection for LNPs
Donald Kelemen, PhD, says one of the most significant challenges lies in selecting and sourcing the molecules at the heart of LNPs: lipids. The right choices can optimize stability, efficacy, and scalability, while the wrong ones can introduce roadblocks that are difficult (and costly) to overcome.
TARGET DISCOVERY PLATFORM - Multi-Omics, SITESEEKER® Technology & the Future of Targeted Protein Degradation
Alberto Moreno, PhD, and Laura Butler, PhD, discuss the challenges associated with gene editing technologies, such as gene-trap, RNAi, and CRISPR technologies, as they do not directly provide functional characterization or inform on the presence of well-defined drug pockets or enzymatic activity of the target genes.
2025 Analytical Testing e-Book - New ICH Guideline Outlines E&L Principles
In this exclusive Drug Development & Delivery e-book, Stevanato Group discusses E&L from the perspective of lyophilized products, common E&L testing challenges, how to mitigate testing risks.
2025 Respiratory Drug Development e-Book - New Devices & Drugs Enhance Compliance & Facilitate Improved Disease Management
In this sixth annual Respiratory e-book, learn more about several companies and their contributions to inhalation drug delivery and device design.
SPECIAL FEATURE- Outsourcing Formulation Development & Manufacturing: CDMOs Are Making Their Supply Chains More Resilient & Secure
Contributor Cindy H. Dubin speaks with many CDMO professionals to get their insights and perspectives on the current state of the industry.
FORMULATION FORUM - Manufacturing of Solid Oral Dosage Forms by Direct Compression
Jim Huang, PhD, and Shaukat Ali, PhD, say not all excipients are well suited for DC, so challenges remain to find excipients compatible to DC due to certain physicochemical properties associated with poor flowability, lack of plasticity, flexibility, and compressibility.
ESG STRATEGY - Sustainable Foundations: Embedding ESG Principles at Every Level
Benedicta A. Bakpa, MSc, says a robust environmental, social, and governance (ESG) strategy is increasingly important for businesses to align with stakeholder values.
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.
CAPMUL GDO (Glycerol Dioleate) is a Versatile Excipient for Pharmaceutical Formulations
ABITEC is excited to present its latest excipient, CAPMUL GDO, Glycerol Dioleate. CAPMUL GDO is a high-purity, highly versatile functional lipid
The Benefits of Transparent Pricing: How to Compare CMO Proposals & Know What Your True Costs Will Be
We want your experience as a pharmaceutical professional responsible for evaluating and selecting a CMO to be different. This article will help you be prepared when choosing a CMO from among multiple candidates.
The Value of Expertise in Aseptic Fill Finish Manufacturing of Biologics
One way to mitigate the risk associated with aseptic fill finish manufacturing of biologics is to partner with a contract manufacturing organization (CMO) demonstrating proven expertise in all aspects of biologics production.
Closing the Access Gap in Pediatric Oncology & Why Neuroblastoma Families Are Still Struggling
Neuroblastoma is a rare pediatric solid tumor that arises from immature nerve cells. It accounts for roughly 15% of childhood cancer deaths, despite being only 6%-10% of diagnoses. Nearly half of children are diagnosed with…
Kindeva e-Book: A Bridge to the Future: Our World-Class Site in Bridgeton
In this e-Book, you will learn about, the integrated capabilities of Bridgeton, MO, which eliminate the risks of fragmentation, the breadth of projects that Kindeva can support, our continuous investment in the facility to ensure it meets today’s demands and the needs of tomorrow, and the benefits of partnering with Kindeva.
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EXCLUSIVE WHITEPAPERS
WHITEPAPER - Drug Delivery – Recent Trends, Enabling Technologies, In-Vitro-In-Vivo Predictions & Personalized Medicine
Enabling technologies such as Nanotechnology, Amorphous Solid Dispersions, Self-emulsifying/nanoemulsifying drug delivery systems (SEDDS/SNEDDS) or Lipid Nano Particles (LNPs) for oral delivery are key elements for the development of complex and difficult to develop small molecules.
WHITEPAPER - 3D Reconstructed Skin Models: Transforming Clinical & Safety Testing
Targeted at researchers, toxicologists and formulation scientists in the clinical and dermatological fields, the white paper provides essential insights into how advanced in vitro skin and mucosal tissue systems are reshaping research and development practices.
WHITEPAPER - OXYCAPT™: Multilayer Plastic Vial: An Optimal Primary Container for Drug Products Transported With Dry Ice
OXYCAPT™ vial is the multilayer primary container with the distinctive structure that includes the gas barrier layer in the middle layer. They offer optimal features for the transport and storage of advanced therapeutics, such as cell and gene therapy products.
WHITEPAPER - Container Selection for a Highly Sensitive Drug Product: A Success Story
When Stevanato Group is involved from the early stages, before the container is even chosen, we can support the client with a comprehensive data-driven analysis so the client can make an informed choice and select the optimal solution for their drug product.
WHITEPAPER: Partnering With Gattefossé to Tackle Veterinary Medicine Challenges
Veterinary medicines face unique challenges due to species diversity, physiology, and dosing needs. Animals can’t be instructed to take medicine, so palatability, safety, and bioavailability are key.
EXCLUSIVE WEBINARS
ON-DEMAND WEBINAR: Drug Product Design for Delivery of Challenging Molecules
In this talk we illustrate several case studies demonstrating how a fundamental understanding of molecular properties combined with a strategic vision for drug product design can lead to effective and advanceable formulations for even the most challenging drug products.
WEBINAR - Vytal: The RTU Snap-Fit System for Container Closure Solutions – Setting the Standard for the Future
In recent decades, the landscape of parenteral drug production has undergone significant transformation, driven by the emergence of novel molecules and advanced therapies. The pharmaceutical industry has witnessed a notable shift towards biologics, mAbs, and cell-based therapies, which now represent some of the most successful pharmaceutical products globally.
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.
MARKET NEWS & TRENDS
FORE Biotherapeutics Presents Phase 1/2a Plixorafenib Data Demonstrating Prolonged Duration of Effect in BRAF Altered Thyroid Cancers
FORE Biotherapeutics recently presented new plixorafenib results from the previously completed Phase 1/2a clinical trial that demonstrate treatment with plixorafenib in patients with BRAF-altered papillary…
Upperton Wins Pharma Contract Services Company of the Year at the Pharma Industry Awards UK 2025
Upperton Pharma Solutions has added another impressive award to a growing list of achievements, winning the award for Pharma Contract Services Company of the Year…
Monte Rosa Therapeutics Announces Collaboration With Novartis for Degraders to Treat Immune-Mediated Diseases
Monte Rosa Therapeutics, Inc. recently announced an agreement to collaborate with Novartis to develop novel degraders for immune-mediated diseases. The agreement is the company’s second…
Abzena Enhances AbZelectPRO Cell Line Offering With New GS Knockout Platforms
Abzena, the leading end-to-end integrated CDMO for complex biologics and bioconjugates, announced the expansion of its AbZelectPRO™ cell line development (CLD) platform with the launch…
Cadrenal Therapeutics Enhances Anticoagulation Pipeline Through Acquisition of eXIthera’s Portfolio
Cadrenal Therapeutics, Inc. recently announced the acquisition of the assets of eXIthera Pharmaceuticals, including its proprietary portfolio of investigational intravenous (IV) and oral Factor XIa…
Spyre Therapeutics Doses First Patient in Pioneering Phase 2 Trial of the First Anti-TL1A Antibody Studied in Rheumatic Diseases
Spyre Therapeutics, Inc. recently announced the first patient has been dosed in its Phase 2 SKYWAY basket trial evaluating SPY072 in RA, PsA, and axSpA.…
Department of Defense Awards Grant to Advance Tiziana Life Sciences' Intranasal Anti-CD3 Therapy for Spinal Cord Injury
Tiziana Life Sciences, Ltd. recently announced that the US Department of Defense (DoD) has awarded a research grant to study the use of intranasal anti-CD3…
Belite Bio Announces Completion a 2-Year, Phase 3 Trial of Oral Tinlarebant in the Treatment of Stargardt Disease
Belite Bio Inc. recently announced the completion of the last subject visit in the Phase 3 DRAGON clinical trial evaluating Tinlarebant for the treatment of Stargardt…
CPHI Frankfurt 2025 to Welcome More Than 60,000 Pharma Professionals as the Global Event Returns to Germany
Informa Markets will once again welcome the global pharmaceutical industry to CPHI Frankfurt 2025, running from October 28 to 30 at Messe Frankfurt. The three-day event…
Silexion Therapeutics Reports Positive Preclinical Data Demonstrating SIL204’s Reach & Activity in Major Pancreatic Cancer Metastatic Sites Following Systemic Administration
Silexion Therapeutics Corp. recently announced new preclinical data demonstrating that subcutaneously administered SIL204 successfully reaches all primary sites of pancreatic cancer metastasis and shows anti-tumor…
Trethera Successfully Completes Enrollment of Phase 1 Dose Escalation Trial for Patients With Solid Tumors
Trethera Corporation recently announced the final patient has enrolled in its Phase 1 dose escalation trial for the treatment of advanced solid tumors. Patients have…
Symeres Acquires DGr Pharma to Enhance Regulatory Expertise & Broaden Biopharma Capabilities
Symeres recently announced the acquisition of DGr Pharma, a drug development-focused consultancy, to expand its integrated early-stage drug development services and accelerate IND-enabling capabilities for…
Karyopharm Announces Completion of Enrollment in the Phase 3 SENTRY Trial in Myelofibrosis
Karyopharm Therapeutics Inc. recently announced it has completed enrollment in the Phase 3 SENTRY trial, which is evaluating selinexor in combination with ruxolitinib in JAKi-naïve…
Biosplice Therapeutics Announces First Patient Dosed in NCI-Sponsored Clinical Trial of Cirtuvivint in AML & Myelodysplastic Syndromes
Biosplice Therapeutics, Inc. recently announced the first patient has been dosed in a Phase 1 clinical trial of cirtuvivint in patients with acute myeloid leukemia…
HCW Biologics Reports Positive Results From Non-Human Primate Study for its Proprietary Second-Generation T-Cell Engager Program
HCW Biologics Inc. recently announced its scientists have successfully developed second-generation, tissue factor-targeting T-cell engagers against solid tumors, particularly for pancreatic cancer and glioblastoma, constructed…
Enlivex Announces Issuance of New Patent Application Covering the Use of Allocetra in Patients With Osteoarthritis
Enlivex Therapeutics Ltd. recently announced the issuance of an Israeli patent, numbered 290470, titled THERAPEUTIC APOPTOTIC CELLS FOR TREATMENT OF OSTEOARTHRITIS. The patent will provide…
Lilly Launches TuneLab Platform to Give Biotechnology Companies Access to AI-Enabled Drug Discovery Models Built Through Over $1 Billion in Research Investment
Eli Lilly and Company recently announced the launch of Lilly TuneLab, an artificial intelligence and machine learning (AI/ML) platform that provides biotech companies access to drug…
Tagworks Pharmaceuticals Announces Initiation of Third Dose Level in Ongoing Phase 1 Clinical Trial for Solid Tumor Treatment
Tagworks Pharmaceuticals BV recently announced the third dose level has been initiated in the ongoing Phase 1 clinical trial evaluating TGW101, a first-in-class antibody-drug conjugate…
Lexicon Pharmaceuticals Announces Submission of Additional Data to FDA Supporting the Benefit-Risk Profile of Zynquista in Type 1 Diabetes
Lexicon Pharmaceuticals, Inc. recently announced it has submitted additional clinical data to the US FDA from ongoing third-party funded, investigator-initiated studies supporting the potential resubmission…
Novonesis & Novo Nordisk to Explore New Solutions for Metabolic Health
Novonesis and Novo Nordisk have entered a research partnership to explore the role of the gut microbiome in the maintenance of metabolic health. The gut…
