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.
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.
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.
Have expert content to share? Contact us
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
AviadoBio & UgeneX Therapeutics Announce Exclusive Option-License Agreement to Develop Next Generation Optogenetics Gene Therapy to Restore Vision in Patients With Retinal Disease
AviadoBio Ltd. and UgeneX Therapeutics, today announced an exclusive option and license agreement for the development and commercialization of UGX-202, an investigational, AAV-based gene therapy…
Ligand Partner SQ Innovation Receives FDA Approval for Lasix ONYU, an At-Home Treatment for Edema in Heart Failure Patients
Ligand Pharmaceuticals Incorporated recently announced that its partner SQ Innovation Inc. has received approval from the US FDA for Lasix ONYU (furosemide injection), a novel…
New Preclinical Data From Encoded Therapeutics Demonstrate Therapeutic Potential of its One-time, Non-opioid Gene Therapy Candidate for Chronic Pain
Encoded Therapeutics Inc. recently announced preclinical data demonstrating that its AAV9 microRNA (miRNA) gene therapy candidate achieved robust knockdown of SCN9A (NaV1.7), a key mediator of…
Rein Therapeutics Receives European Regulatory Approval to Initiate Phase 2 Trial of LTI-03 in Idiopathic Pulmonary Fibrosis
Rein Therapeutics recently announced it has received authorization from the European Medicines Agency (EMA) to initiate the Company’s Phase 2 RENEW clinical trial of its…
Gelteq Announces New Product Development Agreement With Melbourne Health for Novel Bowel Polyp Growth Reduction Compound
Gelteq Limited recently announced it has entered into a Product Development and Profit Share Agreement with Melbourne Health, operator of The Royal Melbourne Hospital and…
Annovis Announces Novel Biomarker Data in Alzheimer’s Patients Supporting Buntanetap’s Potential as a Disease-Modifying Treatment
Annovis Bio, Inc. recently announced new results that demonstrate buntanetap’s ability to attenuate inflammation and improve cellular health in Alzheimer’s patients, suggesting potential disease-modifying effects…
Roquette Boosts Extensive Cyclodextrins Portfolio With Launch of KLEPTOSE® Crysmeb methyl-beta-cyclodextrin for Oral & Parenteral Formulations
Roquette, a global leader in plant-based ingredients and pharmaceutical excipients for the health and nutrition sectors, recently launched of its latest novel pharmaceutical excipient: KLEPTOSE®…
Zenas BioPharma & InnoCare Pharma Announce License Agreement Granting Zenas Rights for Three Autoimmune Product Candidates, Including Orelabrutinib, a BTK Inhibitor in Phase 3 Development for Multiple Sclerosis
Zenas BioPharma, Inc. and InnoCare Pharma Limited recently announced a transformational license agreement granting Zenas global development and commercialization rights to orelabrutinib for Multiple Sclerosis…
Owen Mumford Appoints Mark Glass as Director of Pharmaceutical Services
Owen Mumford, a globally recognised innovator in medical device development and manufacturing, has announced the appointment of Mark Glass as Director of Pharmaceutical Services. With a strong scientific…
Complement Therapeutics Receives FDA IND Clearance to Advance CTx001 Into Opti-GAIN, a Phase I/II Clinical Trial in Geographic Atrophy Secondary to AMD
Complement Therapeutics GmbH (CTx), a biotechnology company developing next-generation therapeutics for complement-mediated diseases, today announced that the U.S. Food and Drug Administration (FDA) has cleared…
Rigel Announces First Patient Enrolled in the Dose Expansion Phase of its Phase 1b Study of R289 in Patients With Lower-Risk MDS
Rigel Pharmaceuticals, Inc. recently announced the first patient has been enrolled in the dose expansion phase of the ongoing Phase 1b study of R289 in…
Lisata Therapeutics & Catalent Announce Global Antibody-Drug Conjugate License Agreement
Lisata Therapeutics, Inc. and Catalent, Inc. recently announced a global product license agreement that allows Catalent to incorporate Lisata’s certepetide into antibody-drug conjugates (ADCs) developed…
Nutriband Files Provisional Patent Application for Enhanced Transdermal Abuse Deterrent Technology
Nutriband Inc. recently announced that it has filed a provisional patent application with the US Patent and Trademark Office (USPTO) to further strengthen Nutriband’s intellectual…
NurExone Demonstrates Reproducible, Dose-Dependent Vision Recovery in Preclinical Glaucoma Model
NurExone Biologic Inc. recently announced new preclinical results showing that its lead candidate ExoPTEN produces a reproducible, dose-dependent therapeutic effect in an eye model of glaucoma.…
Salipro Biotech Strengthens Global IP Portfolio With Two New Patents
Salipro Biotech AB recently announced the issuance of two new patents by the Japanese Patent Office. These patents further solidify the company’s intellectual property (IP)…
Resalis Therapeutics Reports Durable, Fat-Selective Weight Loss With RES-010 in Non-Human Primates
Resalis Therapeutics recently presented new preclinical results on its lead candidate RES-010, a first-in-class antisense oligonucleotide targeting microRNA-22 (miR-22). The data was presented at the European…
GLD Partners LP Launches New Biotech Company to Accelerate Drug Discovery for Muscle-Wasting Diseases
GLD Partners LP recently announced the launch of Altagenics, a new biotechnology company leveraging Heligenics’ proprietary GigaAssay platform to accelerate drug discovery. The collaboration will initially…
RheumaGen & SiVEC Biotechnologies Announce CGT Partnership & In Vivo Program to Cure Common Autoimmune Diseases
RheumaGen, Inc. and SiVEC Biotechnologies, Inc. recently announced a licensing and joint development agreement for a breakthrough class of gene-editing therapies designed to cure autoimmune…
Terumo Announces Completion of Acquisition of WuXi Biologics Drug Product Plant in Leverkusen, Germany
Terumo Corporation recently announced the successful completion of its acquisition of a Drug Product Plant and associated Quality Control Laboratory operations from WuXi Biologics in Leverkusen,…
NanoPhoria Bioscience Secures Funding to Advance Breakthrough Heart Failure Therapy & Expand Portfolio for Novel Nano-in-Micro Delivery Platform
NanoPhoria Bioscience recently announced the successful first close of its €83.5 million Series A financing round. The round was led by XGEN Venture, Sofinnova Partners,…
