SPECIAL FEATURE - Outsourcing Formulation Development & Manufacturing: Connecting Your Project to the Right Service Provider
Outsourcing formulation development and manufacturing can help drug developers address complex dosage forms, scale-up risks, regulatory demands, and accelerated timelines by connecting projects with CDMO partners that offer specialized expertise, integrated workflows, and scalable manufacturing support.
SPECIAL REPORT - Advancements in Respiratory Drug Delivery
Advances in inhaled drug delivery are improving how therapies reach the lungs, with innovations in formulations, devices, biologics, and digital tools helping expand treatment options for respiratory diseases.
CAR T CELL THERAPY - The Rise of Scalable Allogeneic CAR T: Shaping a New Era in Oncology
Allogeneic CAR T therapies are helping move oncology toward more scalable, off-the-shelf treatment models that could expand access, support earlier intervention, and bring advanced cell therapy closer to community cancer settings.
EXECUTIVE INTERVIEW - Dr. Michalis Papadakis Founder & CEO Brainomix
Brainomix founder and CEO Dr. Michalis Papadakis discusses how AI-powered imaging is helping drug developers improve clinical trial design, identify meaningful treatment effects, and advance new therapies in stroke, pulmonary fibrosis, and other areas of unmet need.
DRUG-DEVICE COMBINATION PRODUCTS - Incorporating Self-Administered Drug-Device Combination Products Into Clinical Trials Can Bring Outsized Challenges & Outstanding Rewards
Self-administered drug-device combination products can bring major benefits to clinical trials, improving patient convenience, dosing consistency, compliance, and real-world insight, but they require careful early planning around usability, safety, regulatory requirements, compatibility, manufacturing, and scale-up.
DRUG DELIVERY - Improved Prediction of Food Effect on Oral Absorption
Dissolution-permeation testing is helping drug developers better predict how food affects oral drug absorption by measuring both drug solubilization and membrane permeation, reducing the risk of misleading results from dissolution data alone.
DRUG DEVELOPMENT - Drug Combination Screening in Oncology: Advancing Predictive Strategies for Precision Drug Development
Drug combination screening is helping oncology developers identify synergistic drug pairs, connect response patterns to tumor biology, and support more predictive, biomarker-guided strategies for precision cancer treatment.
SINGLE B CELL ANTIBODY DISCOVERY - Improving Therapeutic Candidate Selection in Drug Development
Single B cell antibody discovery is helping improve therapeutic candidate selection by preserving native heavy- and light-chain pairing, accelerating sequence-defined screening, and enabling earlier identification of candidates with stronger specificity, function, and developability.
CHEMOENZYMATIC LIGATION - Enabling Scalable, Sustainable Oligonucleotide Manufacturing
Chemoenzymatic ligation offers a scalable, more sustainable path for oligonucleotide manufacturing by combining SPOS fragment production with enzymatic assembly to improve purity, reduce impurities, and support growing demand for nucleic acid therapeutics.
CONTROLLED RELEASE - Precision in Every Dose: Advancing Controlled Release for Small Molecule Therapeutics
Controlled release technologies are helping small molecule therapeutics deliver more consistent drug exposure, improve patient adherence, reduce dosing frequency, and support more precise treatment through advanced formulation and delivery strategies.
BIOCATALYSIS - Biocatalysis Without Barriers for Efficient Small Molecule Process Development
Masha Kononov and Reuben Carr examine both the promise and the practical constraints of biocatalysis in modern drug substance development, as well as the role of contract research, development and manufacturing organizations (CRD-MOs) in meeting the evolving demands of modern small molecule synthesis.
SPECIAL FEATURE - PFS & Parenteral Manufacturing: Rapid Growth of Injectables Places Unprecedented Demands on Parenteral Manufacturing
Contributor Cindy H. Dubin highlights many of these CDMOs as well as innovations in the PFS sector.
FORMULATION FORUM - Supercritical Carbon Dioxide (scCO2) for Improving Solubility & Oral Bioavailability of Drugs
Shaukat Ali, PhD, and Jim Huang, PhD, discuss as more new chemical entities coming out of discovery are poorly soluble (BCS Class II and IV), the scCO2 is taking an aim to find the desired solutions to help improve the bottleneck in the industry.
TKIS - Next-Generation BCR-ABL TKIs for CML: The Allosteric Era
Emil Kuriakose, MD, explores the current CML treatment landscape, ongoing clinical challenges, and the potential of next-generation TKIs currently in development, offering hope for the growing CML community.
SELF ADMINISTRATION - Smarter, Kinder, Simpler: EcoSafe Sets a New Standard for Sustainable Self-Administration
Mark Glass takes a novel approach to serve a patient group, with the ambitious aims of increasing the inclusivity of its existing 1mL safety syringe, simplifying procurement, reducing cost, and reducing carbon footprint.
Expert Insights Videos
Go beyond the written word with our new podcast series, featuring in-depth conversations with industry leaders shaping the future of drug development and delivery. Each episode explores real-world challenges, emerging technologies, and the insights driving innovation across the pharmaceutical landscape.
Small Batches, Big Impact: The New Realities of CDMO Formulation Development
IN THIS MONTHS EXPERT INSIGHTS SPECIAL FEATURE WITH CINDY DUBIN - Are CDMOs really the heartbeat of the changing pharma landscape? Here's what we found...…
Enhancing Drug Bioavailability: Solubility Techniques and Innovations
Improving the bioavailability of poorly soluble drugs continues to be a critical focus in pharmaceutical development. Many active pharmaceutical ingredients (APIs), particularly those classified under…
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.
Navigating FDA QMSR in 2026
How medical device manufacturers can move beyond checklist compliance and build inspection-ready quality systems
For years, many medical device manufacturers approached FDA inspections through a familiar lens: prepare documents, review subsystem requirements, rehearse likely questions, and demonstrate compliance against a known framework.
eBook: Understanding the Foundation of LNP Formulation Success
Lipid nanoparticles (LNPs) are one of the most significant advances in drug delivery in decades. But developing successful LNP formulations demands deep knowledge of their key building blocks: Lipids.
Avoiding Recalls: How to Ensure Sterility in Ophthalmic Products
In the wake of several high-profile eye drop recalls, we look at the challenges of achieving sterility in ophthalmic products, the consequences of failing to do so, and how AbbVie Contract Manufacturing ensures product sterility and safety.
On-Demand Presentation: Analytical Strategy & Challenges for ADC
Global Vice President of Analytical & Research Development, Scott Zugel, spoke at Veranova’s SCALE Symposium, where he outlined key analytical strategies and challenges in ADC manufacturing in the pharmaceutical industry.
America’s Next Healthcare Crisis Is Already Here - And We’re Not Ready
Bryn L. Dubin, Master’s Student at the LBJ School of Public Affairs studying health and economic policy. Dubin has federal and state legislative and policy analysis experience.
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WHITEPAPERS & WEBINARS
WEBINAR ON DEMAND: Why early matters: Data-driven strategies to de-risk OSD development
This on-demand webinar focuses on how data-driven characterization, predictive modeling, and Quality by Design (QbD) approaches help teams identify and address risks earlier—when decisions are more flexible and impacts easier to manage, before scale-up begins.
eBook - An Introduction to PLG Polymers for Long‑Acting Drug Delivery
Bioabsorbable poly(lactide-co‑glycolide) (PLG) polymers and poly(lactic acid-co-glycolic acid) (PLGA) have become an essential part of modern healthcare. Over the past five decades, these polymers have…
WHITEPAPER - From Service Provider to Strategic Partner
As drug development grows more complex and timelines compress, sponsors require CDMO relationships built on integration, flexibility, and shared accountability.
WHITE PAPER - Stop Guessing. Start Predicting: Rethinking Early Oral Drug Development
This article explores how AI-driven predictive insights reduce uncertainty in early oral drug development, enabling smarter decisions on solubility, dosing, stability, and scale-up while preserving API, accelerating timelines, and de-risking clinical success .
WHITE PAPER - Small Molecules: Choosing the Right Development Path
This white paper outlines a structured, risk-minimized approach to early CMC (Chemistry, Manufacturing, and Controls) development for small-molecule drugs—particularly for startups and virtual pharma companies with limited resources.
WHITE PAPER - How Advanced Containment Technology Is Reshaping High-Potency API Micronization
Harry Wade, Technical Associate, and Rosie Bird, EHS Lead, Catalent Dartford, review how for many high-potency APIs, micronization is not a downstream convenience but a critical performance step. Particle size distribution directly influences dissolution behavior, bioavailability, blend uniformity, and dose accuracy, particularly when therapeutic doses are measured in micrograms.
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.
eBook - 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.
MARKET NEWS & TRENDS
Evonik invests US$100 million to upgrade its U.S. drug substance contract manufacturing site
Essen, Germany. Evonik is making a significant investment to strengthen manufacturing capabilities at its Lafayette (Tippecanoe), Indiana facility. Over the next five years, the company…
Fonseca Biosciences Launches XTORO (finafloxacin otic suspension) 0.3% for Acute Otitis Externa
LONG BEACH TOWNSHIP, N.J. — Fonseca Biosciences, a specialty pharmaceutical company commercializing clinically differentiated pharmaceutical products, today announced the launch of XTORO (finafloxacin otic suspension),…
FUJIFILM Biotechnologies Selected in FDA PreCheck Pilot Program to Advance U.S. Drug Manufacturing
HOLLY SPRINGS, NC, FUJIFILM Biotechnologies (Fujifilm), a world-leading contract development and manufacturing organization (CDMO) for biologics, vaccines, and advanced therapies, today announced that its commercial-scale…
AustinPx Expands KinetiSol Technology Commercial Access through Thermo Fisher Scientific Collaboration
GEORGETOWN, Texas -- AustinPx, a contract development and manufacturing organization (CDMO) specializing in bioavailability enhancement for orally delivered small molecule drugs, today announced its agreement…
Codis To Acquire Catalent's Nottingham, UK Facility to Create Europe's Leading End-to-End Spray Dry Capability
HAVERHILL, England, Codis, a global contract development and manufacturing organization (CDMO) specializing in spray drying, amorphous solid dispersions (ASDs), and advanced particle engineering solutions, today…
BioPhorum Unites Regulators, Big Pharma and CDMOs to Accelerate Synthetic Molecule Innovation
LONDON - BioPhorum has announced the formation of the Synthetic Molecule Process Innovation Phorum, uniting an ecosystem of 20 leading organizations to urgently address the…
Lonza Expands HPAPI Capacity in Visp, Further Supporting its Position in Payload-Linker Manufacturing
Basel, Switzerland, – Lonza, a leading contract development and manufacturing organization (CDMO), today announced plans to enhance its drug-linker center of excellence and expand payload-linker…
Genmab and AbbVie Announce Topline Results for EPKINLY + lenalidomide in R/R DLBCL
Genmab and AbbVie announced positive topline results from the Phase 3 EPCORE DLBCL-4 trial. The trial met its primary objective, demonstrating statistically significant and clinically…
SUIC and VisionRenu Sign Strategic MOU to Accelerate AI Biotechnology, Precision Medicine, and U.S. Capital Market Expansion
NEW YORK, NY and TAIPEI, TAIWAN - SUIC Worldwide Holdings Ltd., a technology-enabled investment and business acceleration company, and VisionRenu Biomedical Technology Co., Ltd., a…
ten23 health obtains ATMP Manufacturing GMP Licenses from Swissmedic for its Basel and Visp facilities
Basel & Visp, Switzerland, ten23 health, a global contract development and manufacturing organization (CDMO) focused on sterile and biologic drug products, announced it has successfully…
AbbVie has announced it will acquire Apogee Therapeutics
AbbVie has announced it will acquire Apogee Therapeutics for approximately $10.9 billion in an all-cash transaction, gaining access to zumilokibart, a late-stage immunology asset with…
ProMed Pharma Announces Second Dedicated Manufacturing Suite Agreement at Niagara Lane Facility
PLYMOUTH, MN, UNITED STATES, - ProMed Pharma a leading contract development and manufacturing organization (CDMO) specializing in long-acting injectable and implantable drug delivery systems, today…
Oryn Therapeutics Advances Next Phase of Orynotid Macrocyclic Peptide Platform Development with Expanded Leadership Team and Board Anchored by Accomplished Life Sciences Industry Veterans, Company Builders and Drug Developers
LOS ANGELES, CA – Oryn Therapeutics, a biotechnology company developing a novel class of immune-reprogramming macrocyclic peptides, today announced a series of strategic developments supporting…
Oxford BioTherapeutics’ Third Partnered Programme with Boehringer Ingelheim Enters the Clinic and its First (Obrixtamig) Advances to Phase 3
Oxford, UK, and San Jose, California, – Oxford BioTherapeutics (“OBT”), a clinical-stage oncology company specialising in proteomics-driven target discovery for antibody-based therapies enabled by its OGAP-Verify platform,…
Lonza and InduPro Announce Licensing Agreement to Advance Next-Generation ADC Therapeutics
Basel, Switzerland, – Lonza and InduPro, a biotechnology company pioneering next-generation therapeutics through the targeted proximity of cell-surface proteins, today announced a new licensing agreement to…
ViiV Healthcare advances paediatric HIV regulatory submissions with FDA Priority Review for Tivicay PD and EMA validation of marketing application for Tivicay
London, – ViiV Healthcare, the global specialist HIV company majority owned by GSK, with Shionogi as a shareholder, today announced that the U.S. Food and Drug Administration (FDA) has accepted the supplemental New Drug…
Alcami Expands Quality, Packaging, and Storage Capabilities at Tennessee Facility
Wilmington, North Carolina,– Alcami Corporation, a leading contract development and manufacturing organization (CDMO), today announced a series of strategic and operational investments at its Tennessee…
Mabion reactivates MabionCD20 through rare disease collaboration with Oddifact
Mabion S.A., a Polish biotechnology company, has signed a letter of intent (LoI) with French TechDev company Oddifact SAS to evaluate and advance MabionCD20 for…
LabGenius Therapeutics and LG Chem Enter a Research Collaboration, Option and License Agreement to Develop an AI/ML-Designed Tumour-Targeting Antibody
LONDON, United Kingdom — LabGenius Therapeutics (“LabGenius”), a drug discovery company combining machine learning (ML) and high-throughput experimentation to optimise therapeutic antibodies, today announced a…
InnoGI Technologies Launches TIM Cell to Bridge the Gap Between Bioaccessibility and Absorption
Delft, The Netherlands, InnoGI Technologies announced the launch of TIM Cell, a novel apparent permeability service designed specifically to work with TIM intestinal fluids (TIF).…
