CGT MANUFACTURING - Scaling CGT Manufacturing Inside the US: The New Regulatory Paradigm
John Tomtishen says amid shifting FDA priorities as well as developing geopolitical considerations, US companies are entering a new regulatory era, one that will define how CGTs are scaled, distributed, and delivered domestically.
SPECIAL FEATURE - Excipients: Innovation in a Shifting Pharma Landscape
Cindy H. Dubin speaks with several companies and highlights this innovation and reveals how excipient suppliers are doing their part to ensure a reliable, resilient, and compliance-driven supply chain.
FORMULATION FORUM - Orally Disintegrating Tablets
Shaukat Ali, PhD, and Jim Huang, PhD, say as more NCEs are being discovered, the industry is weighing all options for evaluating those molecules in different dosages to improve solubility and oral bioavailability. With requirement for taste-masking of bitter drugs with commercially available ODT excipients, it poses additional challenges for improving taste-masking and performance of molecules for the intended usages.
PRECLINICAL SCREENING PLATFORM - From Preclinical Screening to Clinical Optimization: Accelerating Poorly Soluble Drug Development
Andrew Parker, PhD, John McDermott, and Sandeep Kumar, PhD, believe the development of poorly soluble drugs remains a significant challenge in pharmaceutical R&D. However, by adopting an adaptive approach that integrates services from preclinical screening to clinical optimization, developers can achieve significant time- and cost-saving benefits.
LIPID FORMULATION DEVELOPMENT - Why Softgels Are the Technology of Choice
Dipanwita De, PhD, and Kaspar van den Dries say solubility and bioavailability in OSD formulations remain major challenges within the early stages of drug development. While technological innovations have allowed the pharmaceutical industry to make progress in solving this hurdle, choosing formulations that help achieve desirable solubility and bioavailability can help speed up development of the most promising molecules.
CONTAINER SELECTION - Why Container Selection is Key to Overcoming Sterile Fill & Finish Challenges for Next-Gen Biologics
Vincenza Pironti explores the importance of container selection for sterile injectable drug products and outlines key factors to consider to optimize the performance, quality, and efficacy of biologics.
EXCIPIENT TECHNOLOGY - Driving Oral Drug Delivery Innovation With Safe, Reliable Lipid Excipients
Nick DiFranco, MEM, says amidst the uncertainty of novel ingredients and formulation techniques, lipid excipients provide a safe, proven platform for enhancing in vivo formulation performance, enabling innovation without sacrificing scalability or regulatory confidence.
CLINICAL TRIALS - Keeping Pace With Shifting Drug Development Paradigms for Multi-Indication Therapies
Simon Bruce, MD, and Jack L. Martin, MD, indicate that as developers increasingly embrace multi-indication development, the success of multi-indication therapies will stem not merely from pipeline adjustments, but also from development strategies designed with multi-indication objectives at their core.
EXECUTIVE INTERVIEW - Intensity Therapeutics: Providing Cancer Patients With Treatments That Work
Lew Bender, Founder and CEO of Intensity Therapeutics, discusses the company’s science, clinical program, the drug development process, and more.
Navigating the Fill Finish Process - e-book
You’re here, likely because you are seeking formulation, sterilization, and filling services for your drug. Our guide maps out the journey from onboarding to batch release and highlights facility differences between CMOs so you can understand the impact on your product quality and safety. So, let’s get started!
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.
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.
To Improve Upon a Miracle Drug: Overcoming Drug Resistance & Intolerance in CML
Thanks to the pioneering work of researchers advancing our knowledge of basic science and cancer, the field has been able to transform the lives of millions of patients with CML. But challenges remain, and everyone in the industry strives to improve upon the “miracle drug” imatinib, that was approved almost 25 years ago.
EXECUTIVE INTERVIEW - Incannex Healthcare: Pioneering the Future of Cannabinoid and Psychedelic Therapies
In this exclusive interview, Latham shares how the company navigates complex global regulatory pathways, building strategic collaborations, and forging a path toward commercial success that balances both scientific rigor and therapeutic optimism.
From Concept to Optimization: A Step-by-Step Guide to SEDDS for Enhanced Oral Bioavailability
Join Dr. Masumi Dave, Application Lab Manager at Gattefossé USA, for a practical, step-by-step guide to developing optimized Self-Emulsifying Drug Delivery Systems (SEDDS). This webinar provides a proven framework you can apply in your lab to overcome solubility and permeability challenges with lipid excipients.
Insights From KPMG: Life Sciences CEOs Double Down on AI & Workforce Readiness
Life sciences CEOs are making decisive moves to secure long-term growth, and the message is clear: standing still is not an option. Findings from the KPMG 2025 CEO Outlook survey show leaders are strategically investing in AI, talent, and operational agility – choosing to accelerate rather than retreat.
How Can a Stage-Based Program to Determine HME Applicability Benefit Your API?
Low bioavailability due to poor API solubility is one of the major challenges to be overcome when developing oral dosage form drug products. An effective way of addressing this problem is to transform low solubility APIs into amorphous solid dispersions (ASDs) and can often be achieved via hot melt extrusion (HME).
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EXCLUSIVE WHITEPAPERS
WHITE PAPER - Advancements in Intradermal Delivery: From Historic Techniques to Modern Innovations
This white paper explores the evolution of intradermal delivery methods, comparing historic methods of delivery such as the Mantoux technique with modern innovations such as the Terumo Immucise™ Intradermal Injection System.
WHITE PAPER - An Insoluble Problem? Overcoming Oral Drug Solubility Challenges With Functional Polymers
There are three key factors that need to be controlled when designing a drug product for solubility enhancement: the polymeric carrier; the manufacturing process; and the match to the desired API. By controlling these three factors bioavailability, drug release profile and manufacturability of your final drug product can be controlled.
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.
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
Croda Expands Biopharma Capabilities Through Strategic Partnership
Croda International Plc recently announced a strategic supply partnership with Amino GmbH aimed at strengthening the global availability of high purity amino acids for pharmaceutical…
Sever Pharma Solutions Appoints Linda Rebert as VP Operations
Sever Pharma Solutions, a leading Contract Development and Manufacturing Organization (CDMO) specializing in Controlled-Release Drug Delivery Systems for highly potent drugs, with development and manufacturing…
Bracco, Limula & University of Fribourg Join Forces to Improve Cell & Gene Therapy Manufacturing
Bracco Imaging and Limula recently announced the launch of a research and development (R&D) project in collaboration with Prof. Nicola Vannini, an expert in T-cell…
Amphista Therapeutics Announces New AMX-883 Data to be Presented & Provides a Business Progress Update
Amphista Therapeutics recently announced the presentation of new preclinical data with its lead Targeted Glue AMX-883, an orally bioavailable, potent and selective degrader of BRD9…
Kymera Therapeutics Announces First Patient Dosed in BROADEN2 Phase 2b Atopic Dermatitis Clinical Trial of a First-in-Class, Oral STAT6 Degrader
Kymera Therapeutics, Inc. recently announced it recently initiated dosing in its BROADEN2 Phase 2b clinical trial evaluating KT-621, an oral, highly selective, potent degrader of…
Biodexa Activates First European Site for Registrational Phase 3 Serenta Trial in FAP
Biodexa Pharmaceuticals PLC (Nasdaq: BDRX) recently announced the University of Bonn, Germany is now actively screening patients for the Phase 3 Serenta clinical trial evaluating…
Sever Pharma Solutions Celebrates 50 years of Pharmaceutical Innovation
Sever Pharma Solutions, a leading Contract Development and Manufacturing Organization (CDMO) specializing in controlled release drug delivery systems for high-potent drugs, is proud to celebrate…
Azalea Therapeutics Presents New Preclinical Data Demonstrating Robust In Vivo Generation of TRAC-CAR T Cells Using Enveloped Delivery Vehicles
Azalea Therapeutics, Inc. recently announced new preclinical data demonstrating robust in vivo generation of functional TRAC-CAR T cells using its proprietary Enveloped Delivery Vehicle (EDV) technology.…
BriaCell & Receptor.AI to Collaborate on AI Driven Small Molecule Cancer Therapeutics
BriaCell Therapeutics Corp. recently announced its subsidiary, BriaPro Therapeutics Corp., has initiated a research collaboration with Receptor.AI, an AI-driven drug discovery company, to design anti-cancer…
Oncotelic Achieves Breakthrough $1.7 Billion Pipeline Valuation Through GMP Bio Joint Venture
Oncotelic Therapeutics, Inc. recently announced its joint venture partner, GMP Bio, has completed an independent third-party valuation of its drug development pipeline. The preliminary valuation,…
FibroBiologics Receives HREC Approval for Phase 1/2 Clinical Trial for CYWC628 for the Treatment of Refractory Diabetic Foot Ulcers
FibroBiologics, Inc. recently announced it has received both public and private Human Research Ethics Committee (HREC) approvals in Australia for a Phase 1/2 clinical trial…
Novartis Announces Plans to Build Flagship Manufacturing Hub in North Carolina
Novartis recently announced plans to expand its operations in North Carolina, creating a new flagship manufacturing hub with end-to-end manufacturing capabilities. The strategic investment is…
Gattefossé Celebrates 20 Years in China; Two Decades of Growth, Partnership & Innovation
Gattefossé, the French specialist in lipid chemistry and plant-based ingredients for the personal care and pharmaceutical industries, celebrates 20 years of presence in China. On…
Protara Therapeutics Announces Positive Interim Results Demonstrating Robust Responses in the Ongoing Phase 2 STARBORN-1 Trial of TARA-002 in Pediatric Patients With Lymphatic Malformations
Protara Therapeutics, Inc. recently announced positive interim results from its ongoing Phase 2 open-label STARBORN-1 trial assessing intracystic injection of TARA-002, the Company’s investigational cell-based therapy,…
Nasus Pharma Announces Initiation of Phase 2 Clinical Study of NS002 with First Participant Dosed
Nasus Pharma Ltd. recently announced the successful initiation of the Company's Phase 2 clinical study with dosing of the first participant in Canada. The trial…
Agomab Announces Positive Topline Phase 2a Data for Ontunisertib in Fibrostenosing Crohn’s Disease
Agomab Therapeutics NV recently announced positive data from 103 participants completing 12 weeks of treatment in the STENOVA1 Phase 2a clinical trial for ontunisertib (AGMB-129),…
One-carbon Therapeutics AB Announces First Subject Dosed in the ODIN Phase 1/2 Clinical Study of TH9619 in Advanced Solid Tumors
One-carbon Therapeutics AB recently announced the first subject has been successfully dosed in its ODIN Phase 1/2 clinical trial (NCT07151040) evaluating TH9619, a first-in-class MTHFD1/2…
Acumen Pharmaceuticals Announces First Participant Dosed in Phase 2 Open-Label Extension Study of Sabirnetug in People With Early Alzheimer’s Disease
Acumen Pharmaceuticals, Inc. recently announced the first participant has been dosed in the open-label extension (OLE) portion of its Phase 2 ALTITUDE-AD clinical trial evaluating…
LifeMD to Offer Market-Leading Pricing for GLP-1 Medications Wegovy & Ozempic in Continued Collaboration With Novo Nordisk
LifeMD, Inc. recently announced a new, lower cash-pay price for GLP-1 medications, Wegovy and Ozempic, made possible through its ongoing collaboration with Novo Nordisk. LifeMD will…
Halda Therapeutics Announces Acquisition by Johnson & Johnson
Halda Therapeutics recently announced it has entered into a definitive agreement pursuant to which Johnson & Johnson will acquire Halda for $3.05 billion, payable in…
