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.
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).
Nitrosamine Risk Assessment and Mitigation in Pharmaceutical Products
This paper explores practical approaches for identifying and mitigating nitrosamine risks in drug products, integrating emerging tools such as predictive machine learning, advanced nitrite testing methodologies, and strategic excipient sourcing.
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.
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EXCLUSIVE WHITEPAPERS
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.
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.
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
Eder Therapeutics & XCubeBio Partner to Establish Joint NewCo for Global Development & Future Market Entry Activities
Eder Therapeutics, a Canadian biopharmaceutical company focused on rare genetic disorders and XCubeBio AG, a biotechnology platform company focused on accelerating successful international market entry…
Rein Therapeutics Receives FDA Clearance to Resume Phase 2 Trial of LTI-03 in Idiopathic Pulmonary Fibrosis
Rein Therapeutics recently announced the US FDA has lifted the full clinical hold on the Company’s Phase 2 “RENEW” trial evaluating LTI-03 in patients with…
InterCure & Cannasoul Sign Strategic Investment & Collaboration Agreements to Advance Cannabis Science & Pharmaceutical Innovation
InterCure Ltd. recently announced it has entered into a definitive Share Purchase Agreement and a Collaboration Agreement with Cannasoul R&D Ltd. (“Cannasoul”), a globally recognized…
Trelleborg Expands Biopharmaceutical Manufacturing Capabilities in US
Trelleborg Medical Solutions announces the grand opening of its expanded manufacturing facility and BioPharma Center of Excellence in Northborough, Massachusetts, driving its strategy for growth…
Piramal Pharma Solutions Formalizes Partnership With IntoCell, Expanding its Payload-Linker Platform & Bioconjugate Capabilities
Piramal Pharma Solutions has signed a Memorandum of Understanding (MOU) to solidify its strategic partnership and explore potential collaboration opportunities in ADC development with IntoCell Inc.…
4DMT Announces Exclusive License Agreement With Otsuka Pharmaceutical for Development & Commercialization of 4D-150 in Asia-Pacific
4D Molecular Therapeutics recently announced a strategic partnership with Otsuka Pharmaceutical Co., Ltd. (Otsuka) to develop and commercialize 4D-150 for the treatment of wet age-related…
Clearmind Medicine Advances Fight Against Cocaine Addiction With Publication of US Patent Application for its Non-Hallucinogenic Neuroplastogen MEAI Therapy
Clearmind Medicine Inc. recently announced the publication of a US patent application expanding coverage of its non-hallucinogenic proprietary compound, 5-methoxy-2-aminoindane (MEAI), for the treatment of…
Zag Bio Launches With $80 Million Financing to Advance Thymus-Targeted Medicines for Autoimmune Diseases
Zag Bio, Inc. recently announced the company’s launch with $80 million in financing, including a recently closed Series A financing. Polaris Partners founded and incubated Zag…
Slingshot Biosciences & Cellares Combine TruCytes Biomarker Controls With Cell Q Platform to Enhance Quality & Automation in Cell Therapy Manufacturing
Slingshot Biosciences recently announced a strategic collaboration with Cellares that integrates Slingshot’s TruCytes Biomarker controls into Cellares’ Cell Q, the industry’s first fully automated quality-control…
Olympia Pharmaceuticals Strengthens National Presence, Bringing New Licensing to Mississippi
Olympia Pharmaceuticals recently announced its expansion into Mississippi after successfully obtaining licensing in the state. This is a significant step in its goal to support…
Zenas BioPharma Announces Positive Results From Phase 2 MoonStone Trial of Obexelimab in Relapsing Multiple Sclerosis
Zenas BioPharma, Inc. recently announced positive results from the Phase 2 MoonStone trial of obexelimab in Relapsing Multiple Sclerosis (RMS). Obexelimab met the primary endpoint,…
IN8bio Presents T cell Engager Data Demonstrating Deep B Cell Depletion for Autoimmune Indications
IN8bio, Inc. (Nasdaq: INAB), a clinical-stage biopharmaceutical company developing innovative gamma-delta (γδ) T cell therapies for cancer and autoimmune diseases, today presented new preclinical data…
NodThera Announces First Patients Dosed in RESOLVE-2 Clinical Trial Evaluating Oral NT-0796 in Combination With a GLP-1 Receptor Agonist
NodThera, a clinical-stage biotech pioneering a paradigm shift in the treatment of chronic inflammatory diseases through NLRP3 inhibition, today announced that the first patients have…
Curia Invests $4 Million to Enhance Sterile API Manufacturing
Curia Global, Inc. (Curia), a leading global research, development and manufacturing organization, today announced the completion of a $4 million investment to upgrade its two…
Thermo Fisher Scientific Showcases Enhanced Accelerator Drug Development Capabilities & OpenAI Strategic Collaboration at CPHI Frankfurt 2025
Thermo Fisher Scientific Inc., the world leader in serving science, will showcase its latest flexible solutions to help boost efficiency and scale in biopharmaceutical manufacturing…
Sharp Services Invests $100 Million in US & European Facilities to Increase Capacity & Service Offerings
Sharp Services, a leader in pharmaceutical packaging, clinical trial services & sterile manufacturing has announced a $100 million investment across its global facility network to…
Serán BioScience Expands Commercial Manufacturing With New Campus in Bend, Oregon
Serán BioScience, LLC, a leading science-driven drug development partner, today announced the completion of two of the three new buildings and commencement of construction of…
Orion & Abzena Announce Exclusive Commercial License for Abzena’s Antibody
Abzena, the leading end-to-end integrated CDMO for complex biologics and bioconjugates, today announced that Orion has obtained an exclusive focused commercial license to one of…
Aenova Expands Sterile Fill & Finish Manufacturing Capacity at its Latina Site
Latina (Italy), 23 October 2025 – Aenova, a leading global contract development and manufacturing organization (CDMO), announces a major investment in its sterile manufacturing capabilities…
Kindeva Announces the Appointment of David Stevens as President
Kindeva, a global contract development and manufacturing organization (CDMO) and drug delivery innovator, announced the promotion of David Stevens, Chief Operating and Commercial Officer, to…
