Formulation Development
LEADERSHIP PANEL - What Will Have the Most Impact on Drug Development in 2025?
Contributor Cindy H. Dubin asked several life science leaders what they believe will have the greatest impact on drug development in 2025.
FORMULATION FORUM - Nanoparticle Technologies for Oral Delivery of Peptides & Proteins
Jim Huang, PhD, and Shaukat Ali, PhD, examine various nanoparticle technologies in oral delivery of large molecules.
Silo Pharma Announces Positive Initial Pharmacokinetic, Safety & Tolerability Study of SP-26 for Chronic Pain and Fibromyalgia
Silo Pharma, Inc. recently announced a positive update from an ongoing study evaluating the pharmacokinetics, safety and tolerability of its novel SP-26 ketamine extended-release rods…
MICRONEEDLE MANUFACTURING - The Value of a Manufacturing-Oriented Microneedle Mindset
Andrew Riso says despite the significant buzz surrounding microneedle technology, a considerable gap remains between innovations and market-ready products. While early stage development and preclinical studies have shown promising results, the challenge of translating these advancements into scalable, commercially viable products persists.
EXECUTIVE INTERVIEW - Resilience Rising: Advancing Therapies That Transform Lives
Dr. Susan Billings, Chief Commercial Officer of Resilience, discusses pressing issues in the CDMO space, the opportunities driving innovation, and how her company is shaping the future of drug substance and drug product manufacturing.
DRUG DEVELOPMENT - What is Formulation Development & Why is it Important?
Rob Holgate, PhD, and Nicola Watts, PhD, explain how this process involves a delicate balance of scientific rigor and practical application, and not only requires a profound understanding of the drug’s properties, but also the ability to navigate the many challenges of delivering the drug in an effective and patient-centric manner.
EXECUTIVE INTERVIEW - Lifecore Biomedical: Capacity to Keep Pace With Biologics Growth
Drug Development & Delivery recently interviewed Thomas Guldager, Vice President, Operations at Lifecore. With a 40+ year regulatory track record, Lifecore is a fully integrated CDMO with highly differentiated capabilities in the development, fill and finish of sterile injectable pharmaceuticals, including 20+ commercial products.
VACCINE DEVELOPMENT - Enhancing Pandemic Preparedness With Mosaic-8b Nanoparticles
Leonardo Magneschi, PhD, says although the mosaic-8b vaccine is still in early development, it has the potential to enable a broad and cross-reactive immunization strategy that could provide comprehensive protection against known and unknown sarbecoviruses.
OUTSOURCING PHARMA DEVELOPMENT - Harnessing CDMOs for Innovation & Efficiency
Rohtash Kumar, PhD, says a strategic partnership with a trusted CDMO can provide many benefits ranging from experts’ insights to state-of-the-art equipment. However, there are several considerations that developers should evaluate prior to engaging with a CDMO to maximize their partnership.
NEW PRODUCT INTRODUCTION - Addressing the Pitfalls of Progressing From Pilot to Product Through Effective New Product Introduction
Uwe Hanenberg, PhD, Wolfram Bühler, and Radoslaw Kaczanowski, PhD, explore the risks and challenges pharmaceutical companies face when undertaking NPI to ensure new products successfully reach the market and patients and examine the strategies CDMOs are adopting to ensure the smooth delivery of these projects from discovery to commercialization.
CELL SEPARATION TECHNOLOGY - Breaking Down Barriers to Unlock a New Era of Cell Therapy
Dr. Liping Yu believes revolutionary cell separation technologies are crucial for enabling these rapid advancements, and will continue to play a growing role in establishing the decentralized, rapid, and cost-effective large-scale manufacture of potentially life-saving cell-based drugs well into the future.
FOCUSED ULTRASOUND - Overcoming Drug Delivery Challenges
Neal F. Kassell, MD, says one promising approach, focused ultrasound (FUS), is emerging as a revolutionary tool, enabling non-invasive, targeted BBB disruption. This method holds transformative potential in delivering therapies for neurodegenerative diseases and other challenging conditions, setting the stage for novel treatments in the years ahead.
Ocean Biomedical Announces Breakthrough Findings in EGFR-Mutant Lung Cancer & Plans for FDA Alignment on Next-Stage Development
Ocean Biomedical recently announced newly published research findings demonstrating the ability of its proprietary cancer immunotherapy candidates to favorably interact with tyrosine kinase inhibitors (TKI),…
Safi Biotherapeutics & ARMI BioFabUSA Initiate Collaboration to Support Large-Scale Development of mRBCs
Safi Biotherapeutics recently announced a collaboration focused on the manufacturing of Safi’s mRBCs to support regulatory requirements and initial clinical studies. “We are very excited…
Biodexa Receives US FDA Fast Track Designation for eRapa in Familial Adenomatous Polyposis
Biodexa Pharmaceuticals PLC recently announced the US FDA has granted Fast Track designation for eRapa, a proprietary encapsulated form of rapamycin being developed for the…
Recipharm Expands Aseptic Filling Capabilities for Process Development, Pilot Scale & Clinical Supply
Recipharm recently announced a new modular sterile filling system specifically tailored for process development, pilot scale and clinical supply, is now fully operational at its…
Alumis & ACELYRIN to Merge Creating a Late-Stage Clinical Biopharma Company
Alumis Inc. and ACELYRIN, INC. recently announced a definitive merger agreement under which Alumis and ACELYRIN will merge in an all-stock transaction. Martin Babler, President,…
Conduit Pharmaceuticals Transitions to Phase 2 of Sarborg Collaboration to Support AI-Driven Drug Development
Conduit Pharmaceuticals Inc. recently announced the successful completion of all milestones in Phase 1 of its strategic collaboration with Sarborg Limited. This transition to Phase…
Maze Therapeutics Doses First Patient in Phase 2 Trial Evaluating MZE829 as a Potential Treatment for APOL1 Kidney Disease
Maze Therapeutics, Inc. recently announced the first patient has been dosed in the company’s Phase 2 clinical trial, the HORIZON Study, of MZE829 in patients…
Thermo Fisher Scientific Launches International CorEvitas Clinical Registry in Adolescent Alopecia Areata
Thermo Fisher Scientific Inc. recently announced the launch of the international CorEvitas Adolescent Alopecia Areata (AA) Registry, addressing a critical unmet need for real-world, adolescent-specific…
