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.
DRUG DELIVERY - Viewing Lipid Nanoparticle Delivery Technology Through the Lens of a CRDMO
Lu Tian, PhD, says the complexity of LNP formulations demands diverse and integrated capabilities for development – incorporating lipids, oligonucleotides, small molecules, and sometimes antibodies or ligands, and thus it requires a cohesive approach.
SILICON-STABILIZED HYBRID LNPS - Next-Generation Delivery of RNA Therapeutics
Suzanne Saffie-Siebert, PhD, Michael Welsh, PhD, Nissim Torabi-Pour, PhD, and Flavia M. Sutera, PhD, review current shortcomings, as well as some accompanying manufacturing challenges, and will show how they can be addressed by SiSaf’s silicon-stabilized hybrid LNPs.
CLINICAL TRIALS - Faithful Migration: Shifting Patient Reported Outcomes From Paper to Electronic
Melissa Mooney says by following certain steps to faithful migration, the shift to electronic measures is efficient and reliable, especially as there is an increasing body of evidence showing that when minor changes are made to an original measure, the resulting ePRO is likely to be considered equivalent.
EXECUTIVE INTERVIEW - Coya Therapeutics: Unlocking the Power of Tregs to Combat Inflammation & Fight Neurodegenerative Diseases
Dr. Howard Berman, Founder and CEO of Coya Therapeutics, discusses how the company is leveraging Tregs, its investigational products and the conditions targeted, Coya’s significant partnership with Dr. Reddy’s Laboratories, and his goals throughout the next 5 years.
2024 Analytical Testing eBook - Providers Offer Versatile, Advanced & Expanded Services
Learn more about Stevanato Group and LGM Pharma in this exclusive Drug Development & Delivery annual Analytical Testing eBook.
2024 Respiratory Drug Development eBook – CDMOs Will Become More Essential to Inhalation Device Programs
In this fifth annual Respiratory e-book, learn more about several companies and their contributions to inhalation drug delivery and device design.
PLATFORM TECHNOLOGY - Antibody Oligonucleotide Conjugates (AOCs™) - Revolutionizing a New Class of Targeted RNA Therapeutics
Arthur A. Levin, PhD, highlights the first-ever successful targeted delivery of RNA to muscle in humans, a revolutionary advancement for the field of RNA therapeutics that may help transform the opportunities to advance research targeting many previously untreatable diseases in the years ahead.
SPECIAL FEATURE - Outsourcing Formulation Development & Manufacturing: Going Beyond the Science to Become True Partners
Contributor Cindy H. Dubin speaks with leading CDMOs about how they are adapting to bio/pharma client needs, their capabilities in handling complex molecules, and how they are transforming from specialist contractors to true partners.
FORMULATION FORUM - Advances in Drug Delivery by Antibody Drug Conjugates (ADCs)
Shaukat Ali, PhD, and Jim Huang, PhD, focus on two aspects of drug delivery through ADCs. One, where an antibody is conjugated via a ligand with functionalized LNPs carrying cytotoxic drugs; and two, where an antibody is conjugated directly with drug through a linker at the specific site.
AMORPHOUS SOLID DISPERSION SPECIATION - Impact of Polymer Chemistry & Drug Properties
Wesley K. Tatum, PhD, focuses on the use of in vitro techniques for characterizing ASD performance and on how these techniques can be used to help better understand the role of polymer chemistry in ASD performance.
EXECUTIVE INTERVIEW - Lonza: Navigating Today’s Challenges in Drug Solubility & Bioavailability
Adi Kaushal, Director and Technology Head, Bioavailability Enhancement at Lonza, discusses solubility and bioavailability challenges and Lonza’s approach.
DEVICE STUDY - Putting Auto-Injector Interchangeability to the Test
Alex Fong, MBA, says many factors need to be taken into account when deciding whether patients can successfully switch to a different drug delivery device because if patients struggle to cope with a new device, there is a risk they will miss out on vital doses of medication.
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.
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.
BASF Article - Should Developers Choose a Cosmetic or Pharmaceutical-Grade Excipient?
As regulations continue to change around cosmetic and pharmaceutical-grade excipients, the pharmaceutical industry has choices to make when investing in quality, risk, and public safety.
BASF VIDEO - Formulation Design for Tablets and an Introduction to Your New All-in-One Tableting Solution
In this video, learn what the formulation and parameter targets are to optimize direct compression formulations, and how to accelerate development with BASF’s new all-in-one fit-for-purpose tableting solution.
Who is AbbVie Contract Manufacturing?
As an embedded CMO, we leverage decades of scientific expertise, operational excellence, and best-in-class facilities to provide you with….
Presentation: Strategies for Amorphous Solid Dispersion Product Development
In this presentation, Dr. Schlesinger demonstrates how to leverage a combination of measured and calculated molecular properties, bio-performance modeling, and a strategic understanding of the product TPP to identify a technology to enable exposure and an appropriate drug product design…..
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EXCLUSIVE WHITEPAPERS
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…
WHITEPAPER - A Holistic Approach to Getting the First Batch Right
Mark Rauckhorst, director of supply chain and project management at leading, global contract development and manufacturing organization (CDMO) Vetter, will share his expert insights on how an outsource….
WHITEPAPER - Continuous Flow - An Emerging Alternative
In the whitepaper Continuous Flow: An Emerging Alternative, Curia experts discuss how continuous flow chemistry and processing offer an alternative pathway. The paper explores its….
EXCLUSIVE WEBINARS
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…..
WEBINAR - Enabling Upstream Intensified Bioprocessing
Intensified upstream bioprocesses are being developed to increase productivity while reducing footprint, costs, and timelines for manufacturing. The higher cell densities generated by….
WEBINAR - Nanoparticle Suspensions: History, Applications & CMC Aspects
This webinar describes the history, CMC aspects, and potential applications of nanoparticle suspensions (NSs). This drug delivery technology should be considered for crystalline, sparingly water-soluble APIs. The presentation highlights….
WEBINAR - Impact of Process Re-design on Sustainability in Pharmaceutical Small Molecule Manufacturing
Join us for an upcoming webinar that delves into a crucial issue in the pharmaceutical industry. Recent research has revealed a surprising fact: the pharmaceutical sector has a larger carbon footprint than even the automotive industry, especially when we consider the entire supply chain’s impact on
MARKET NEWS & TRENDS
Nanoscope Therapeutics Announces End-of-Phase 2 Meeting With FDA & Plan to Initiate a Phase 3 Clinical Trial
Nanoscope Therapeutics Inc. recently announced a productive End-of-Phase 2 (EOP2) meeting with the US FDA for its clinical program evaluating MCO-010 for the treatment of…
Vico Therapeutics Announces Positive Interim Phase 1/2a Clinical Data of VO659 in Treatment of Huntington’s Disease
Vico Therapeutics B.V. recently announced new positive interim data in Huntington’s disease (HD) from the ongoing Phase 1/2a clinical trial of VO659, an investigational allele-preferential…
Biosplice Therapeutics Announces Initiation of AML & MDS Trial Sponsored by the National Cancer Institute
Biosplice Therapeutics, Inc. recently announced the US FDA has cleared the NCI-sponsored Investigational New Drug (IND) application for cirtuvivint. This small molecule inhibitor of CLK…
Vironexis Biotherapeutics Launches With FDA Clearance of IND Application for First-Ever Clinical Trial of an AAV-delivered Cancer Immunotherapy
Vironexis Biotherapeutics launched from stealth, unveiling its TransJoin AAV Gene Therapy Platform and a pipeline of more than ten product candidates for blood-based cancers, solid…
Monopar Announces Positive Early Human Clinical Data Validating the Tumor Targeting Ability of MNPR-101-Zr
Monopar Therapeutics Inc. recently announced positive early data from its ongoing open-label MNPR-101-Zr Phase 1 imaging and dosimetry clinical trial confirming MNPR-101-Zr’s tumor targeting ability…
Cellares & Sony Announce a Joint Development Collaboration to Integrate Flow Cytometry-Based Sorting & Online Analysis Into an Automated, High-Throughput Cell Therapy Manufacturing Platform
Cellares and Sony Corporation recently announced a collaboration to jointly develop and integrate advanced flow cytometry-based cell analysis and sorting solutions into the Cellares Cell…
Enable Injections Announces Agreement with Sobi to Develop & Distribute Aspaveli in Combination With enFuse
Enable Injections, Inc. and Swedish Orphan Biovitrum AB (Sobi) recently announced an international development and distribution agreement for the enFuse Injector, for the subcutaneous delivery…
TFF Pharmaceuticals Announces Positive Preclinical Data From Bivalent Universal Influenza Vaccine Candidates
TFF Pharmaceuticals, Inc recently announced positive preclinical data advancing a multivalent universal influenza vaccine manufactured by TFF to protect against seasonal and pandemic viruses. The…
Agios Announces FDA Orphan Drug Designation Granted for Treatment of Myelodysplastic Syndromes
Agios Pharmaceuticals, Inc. recently announced the US FDA has granted orphan drug designation to the company’s novel pyruvate kinase (PK) activator tebapivat (AG-946) for the…
Ilya Pharma Receives Rare Pediatric Disease Designation From US FDA
Ilya Pharma recently announced that it has received a Rare Pediatric Disease Designation by the US FDA. About SAVI: STING-associated vasculopathy with onset in infancy…
BriaCell Reports Positive Overall Survival in Metastatic Breast Cancer
BriaCell Therapeutics Corp. recently announced positive overall survival data of its Phase 2 clinical study of Bria-IMT in combination with an immune check point inhibitor…
Evonik Starts Operation of New Spray Drying Facility for Pharmaceutical Oral Excipients
Evonik has officially opened a new facility for drying aqueous dispersions of EUDRAGIT polymers at its site in Darmstadt. The new double-digit million-euro excipient manufacturing…
Roivant Unveils New Pipeline Program of a Potential First-in-Class & Best-in-Category Inhaled Once-Daily Soluble Guanylate Cyclase Activator
Roivant recently announced its previously undisclosed pipeline program mosliciguat, a potential first-in-class, inhaled, once-daily sGC activator with targeted delivery to the lungs via dry powder…
Quotient Sciences & Vasa Therapeutics Announce Dosing of First Subjects With Novel Heart Failure Treatment
VS-041, a novel and potentially life-saving treatment for heart failure, developed by Vasa Therapeutics, a San Diego-based biotechnology company, has reached a major clinical milestone…
Incendia Therapeutics Enrolls First Patient in Phase 1c Clinical Trial of a Novel DDR1 Inhibitor
Incendia Therapeutics, a precision oncology company discovering and developing a novel class of therapies that reprogram the tumor microenvironment (TME), recently announced the first patient…
Belite Bio Announces First Patient Dosed in Phase 2/3 Trial of Tinlarebant for the Treatment of Stargardt Disease
Belite Bio, Inc recently announced that the first patient has been dosed at the Tokyo Medical Center in the Phase 2/3 portion of its DRAGON…
Incannex Healthcare Announces Strategic Financing for up to $60 Million
Incannex Healthcare Inc. recently announced it has entered into an agreement to issue up to $10 million in secured convertible notes to Arena Investors, LP…
Tanvex Appoints Biopharma Industry Veteran as New CEO
Tanvex BioPharma, Inc., the biosimilar-focused biopharmaceutical company and CDMO, recently announced its Board of Directors has appointed Stephen Lam as the company's Chief Executive Officer,…
Cartesian Therapeutics Receives FDA Rare Pediatric Disease Designation for Descartes-08 for the Treatment of Juvenile Dermatomyositis
Cartesian Therapeutics, Inc. recently announced the US FDA has granted Rare Pediatric Disease Designation to Descartes-08 for the treatment of juvenile dermatomyositis (JDM). Descartes-08, Cartesian’s…
Hongene Biotech Corporation & ReciBioPharm Establish a Gene Editing Development Partnership
Hongene Biotech Corporation and ReciBioPharm have announced a strategic collaboration that will enhance gene editing drug manufacturing capabilities. Hongene, renowned for its expertise in the…
