SPECIAL FEATURE - Analytical Testing – Diverse Demands & Therapies Require Diverse Analyses
Contributor Cindy H. Dubin highlights how analytical testing has evolved to address diverse pharmaceutical therapeutics in research and 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.
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.
OXYGEN SCAVENGING - Innovative Oxygen Scavenging Technologies for Pharmaceutical Packaging: Ensuring Drug Integrity & Stability
Amanda Murph, Ivy Comer, Jason Pratt, PhD, and Jean Daou, PhD, believe by incorporating novel active materials science technology into active packaging solutions to actively remove oxygen from the packaging headspace, pharma companies can ensure the stability and efficacy of products throughout shelf-life.
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.
2025 COMPANY PROFILES & CAPABILITIES
For each participating company, this section presents a detailed summary highlighting their core technologies, capabilities, technologies, and services.
FORMULATION FORUM - Nanoparticle Technology for Nose-to-Brain Drug Delivery
Jim Huang, PhD, and Shaukat Ali, PhD, say as we continue our investigation of innovative delivery routes for drug molecules besides the parenteral and oral routes, the IN route remains the future method for drug delivery to the brain.
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.
Lyophilization Development: Quality by Design Approach
Lyophilization, or freeze-drying, addresses stability challenges associated with complex APIs, biologics, microbiomes, gene therapies, viral vectors, liposomes, and nanoparticles……
Choosing the Right Particle for Your Nanomedicine Application
Nanoparticles are revolutionizing the landscape of nanomedicine, enabling significant advancements in early detection, targeted drug delivery, disease monitoring, and imaging. Due to their nanoscale size, these particles….
Join us for the inaugural Quotient Sciences Capability Expo, hosted at our state-of-the-art Garnet Valley facility.
This unique event offers a behind-the-scenes look at how we support molecules from preclinical stages through to commercial manufacturing…..
CLINICAL TRIALS - Need for Accessibility to Meet FDA Guidance for Decentralized Trials
Neil Vivian believes advances in electronic data collection and analysis are helping to make DCTs more accessible to broader and more diverse patient populations. Further innovations, particularly in artificial intelligence technology, are expected to accelerate these trends.
On-Demand Presentation: High Concentration Protein Suspensions: A Bevacizumab Case Study (>400 mg/mL)
Dr. Cindy Chung presents a case study demonstrating the development of high concentration bevacizumab suspension at up to 400 mg/mL for suitable subcutaneous delivery of the monoclonal antibody (mAb) therapy. Watch the presentation now to learn more.
Have expert content to share? Contact us
EXCLUSIVE WHITEPAPERS
WHITEPAPER - Formulating Custom Viscosity Blends With POLYOX™ Polyethylene Oxide
Excipient variability plays a critical role in pharmaceutical product design. A risk-based, scientific approach to Quality by Design (QbD) is essential to ensure consistent drug…
CASE STUDY - Overcoming Barriers to Patient Adherence With A Novel Dosage Form
In this CPHI Award-winning case study, learn how Adare scientists took the alternative sprinkle version out of the lab and into the hands of patients.
ARTICLE - A New Framework for Identifying Nitrosamine Risks & Efficiently Derisking Products
Adare’s team of nitrosamine experts have developed a straightforward framework that simplifies the identification of at-risk APIs.
WHITEPAPER - Concept to Commercialization: The Role of CDMOs in Driving Innovation Through Phase-Appropriate Technology Transfers
This whitepaper explores the various types of technology transfer from preclinical to commercial stages and successful strategies to foster innovation.
Technical Brief: Mucoadhesive Polymers in Pharmaceutical Formulations
This technical brief will cover the use of polymers in a variety of dosage forms (buccal/sublingual tablets, liquid, semi-solid formulations, and oral care products) to impart mucoadhesion. The basic mechanism of mucoadhesion and methods to evaluate it in the context of…
EXCLUSIVE WEBINARS
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.
WEBINAR - ABISOL Emulsion Preconcentrate Kit & ABISORB-DC Excipient System for Tableting Lipids
ABITEC Technical Business Director, John Tillotson, RPh, PhD, discusses ABITEC’s latest products: The ABISOL Emulsion Preconcentrate kit for the easy formulation of emulsified drug delivery systems and the….
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.
MARKET NEWS & TRENDS
Gattefossé Achieves Key Milestone With New US Plant Certifications
Gattefossé, a leading provider of specialty ingredients and formulation solutions for personal care and pharmaceutical industries, proudly announces the successful certification of its new manufacturing…
Kaerus Bioscience Successfully Completes Phase 1 Trial & Demonstrates Proof of Mechanism With its Novel BK Channel Modulator KER-0193 Being Developed for Fragile X Syndrome
Kaerus Bioscience recently announces the successful completion of its Phase 1 clinical trial of KER-0193, a novel BK channel modulator the company is developing for Fragile…
Exogenus Therapeutics Chooses Lonza to Develop a GMP-Compliant Process to Manufacture Exo-101, its Lead Exosome-Based Candidate
Exogenus Therapeutics, a Portuguese biotech company, and Lonza, a global development and manufacturing partner to the pharmaceutical and biotech markets, announced today a collaboration to…
BIOVECTRA is Honored With 2025 CDMO Leadership Award for Biologics
BIOVECTRA, a part of Agilent Technologies Inc., is a leading North American CDMO specializing in biologics, mRNA therapeutics, and complex chemistry, proudly announces it is…
Kaerus Bioscience Successfully Completes Phase 1 Trial & Demonstrates Proof of Mechanism With its Novel BK Channel Modulator Being Developed for Fragile X Syndrome
Kaerus Bioscience recently announced the successful completion of its Phase 1 clinical trial of KER-0193, a novel BK channel modulator the company is developing for…
Shilpa Launches "Hybrid CDMO" at DCAT
Shilpa Medicare launches its new full service "hybrid: CDMO at DCAT 2025. The newly formed CDMO will see Shilpa serve both small and large molecules…
CervoMed Announces Positive Results from the Extension Phase of its Phase 2b Clinical Study of Neflamapimod in Patients With Dementia With Lewy Bodies
CervoMed Inc. (NASDAQ: CRVO), a clinical-stage company focused on developing treatments for age-related neurologic disorders (CervoMed or the Company), today announced positive results from the…
Curia Announces Strategic Refinancing to Support Continued Growth
Curia Global, Inc. recently announced it has refinanced its senior secured credit facilities. The transaction provides Curia with incremental capital and extends the maturities of…
OKYO Pharma Files for Fast Track Designation With FDA for Urcosimod to Treat Neuropathic Corneal Pain
OKYO Pharma Limited recently announce the filing of its application for Fast Track designation with the U.S. Food and Drug Administration (FDA) for urcosimod (formerly known…
Purple Biotech Granted New Patent for NT219 in Combination With EGFR Antibody Therapy, Enhancing Global IP Protection in Major Markets
Purple Biotech Ltd. recently announced the U.S. Patent and Trademark Office has issued a patent for NT219 used in combination with epidermal growth factor receptor…
atai Life Sciences Announces Completion of Enrollment in Phase 2b Clinical Trial Evaluating BPL-003 for Treatment-Resistant Depression
atai Life Sciences recently announced the completion of patient enrollment in the eight-week, double-blind, core stage of the global Phase 2b clinical trial evaluating BPL-003 (mebufotenin…
Lisata Therapeutics & GATC Health Consummate First Step in Strategic Collaboration to Use AI to Derisk & Accelerate Drug Development
Lisata Therapeutics, Inc. and GATC Health Corp recently announced the consummation of the first step of an intended multi-part strategic agreement. Under terms of the…
Axplora Expands Commercial Payload Production Capabilities at Le Mans to Strengthen its Leading Position in ADC Manufacturing
Axplora, a global leader in API small molecule and ADC (antibody-drug conjugate) manufacturing, is strengthening its leading position in the commercial manufacturing of ADCs with…
Jupiter Neurosciences & Aquanova AG Announce Strategic Collaboration to Develop Longevity & Healthspan Products
Jupiter Neurosciences, Inc. (NASDAQ: JUNS) (“Jupiter” or the “Company”), a clinical-stage pharmaceutical company developing JOTROL, a patented resveratrol-based platform, today announced a strategic partnership with…
Indaptus Therapeutics Expands Patent Portfolio in China, Japan, and Israel, Strengthening its Intellectual Property for Infectious Disease and Cancer Treatments
Indaptus Therapeutics, Inc. (Nasdaq: INDP), a clinical-stage biotechnology company dedicated to developing novel treatments for cancer and viral infections, announced today that it has secured…
Alzamend Neuro Announces Initiation Date of Phase II Clinical Trial of AL001 for Treatment of Bipolar Disorder to take Place at Massachusetts General Hospita
ATLANTA, March 04, 2025 (GLOBE NEWSWIRE) -- Alzamend Neuro, Inc. (Nasdaq: ALZN) (“Alzamend”), a clinical-stage biopharmaceutical company focused on developing novel products for the treatment…
Cadrenal Therapeutics Announces Collaboration Agreement With Abbott
Cadrenal Therapeutics, Inc. (Nasdaq: CVKD), a late-stage biopharmaceutical company focused on the development of specialized cardiovascular therapeutics, with the late-stage asset tecarfarin, a new oral…
Petros Pharmaceuticals' Proprietary Technology Demonstrates Positive Data in Pivotal Study
Petros Pharmaceuticals, Inc. (Nasdaq:PTPI) ("Petros" or the "Company"), a company focused on expanding consumer access to medication through over-the-counter ("OTC") drug development programs, announces top-line…
Abzena Strengthens Executive Leadership Team With The Appointment of Taylor Boyd as CBO
Abzena, the leading end-to-end integrated CDMO + CRO for complex biologics and bioconjugates, has announced today that Taylor Boyd has joined the company as its…
Veranova Relocates Headquarters to Devens, MA
Veranova is pleased to announce the move of its corporate headquarters to its Devens, Massachusetts facility, one of the company’s principal sites for manufacturing and…
