SPECIAL FEATURE - Injection Devices: Advancements Converge to Expand Patient Possibilities
Cindy H. Dubin speaks with injection device developers about creating devices that are intelligent, intuitive, patient-centric systems that make advanced therapies easier, safer, and more accessible to use at home.
ARTIFICIAL INTELLIGENCE - AI/ML Supporting Biomarker & Target Discovery
William Whitford explains how Artificial Intelligence/Machine Learning provide new capabilities in analyzing the rapidly increasing type and amount of biological data employed in identifying potential biomarker and disease targets
EXECUTIVE INTERVIEW - Portal Instruments: Beyond Springs – Portal Prime Nexus™ Autoinjector is a Versatile Solution for Biologics
As biologics become larger, more viscous, and more complex, software offers a fundamentally better way to control and optimize delivery.
PLATFORM TECHNOLOGY - How a Novel Immunotherapy Platform is Unlocking the Cancer-Fighting Potential of Unconventional T Cells
Michal Sheleg, PhD, shines a spotlight on the promise of MAIT cells to fight cancer by turning to an untapped source: human placentas.
FORMULATION FORUM - High Concentration Biologics for Injectable Drug Delivery
Shaukat Ali, PhD, and Jim Huang, PhD, discuss how the development of high- and ultra-high-concentration biologics aims to enable smaller-volume, patient-friendly subcutaneous injections.
BIOPHARMA MARKET LAUNCH - De-risking Global Market Entry Through Redundant Capacity & Flexible Manufacturing
John Ward and Paul Hamill stress that launch readiness matters as much as development progress. Thus global expansion is shifting to a near-term priority and CDMOs can reduce the risk of a global launch through agile downstream execution.
DELIVERY SYSTEM DEVELOPMENT - Supporting Earlier Delivery-System Decisions in Injectable Drug Development Through a USP <382>-Aligned System-Level Approach
Sarah Masucci and Crystal Salvans highlight a shift from evaluating individual syringe components independently toward system-level qualification of the complete PFS container-closure system, with the goal of simplifying development and supporting product quality and regulatory expectations.
LYOPHILIZATION - Great Expectations: Selecting & Managing CDMO Partnerships for Lyophilized Injectables from Development Through Commercialization
Carrie A. Schults outlines considerations of managing these partnerships with an emphasis on proactive risk management to control timelines and cost.
QUALITY MANAGEMENT SYSTEM - One QMS, Four Delivery Platforms: Can Your Quality System Manage Complexity at Scale?
Melanie Cerullo emphasizes that when quality systems manage rather than react to complexity, faster development and safer more effective medicines ensue.
REGULATORY COMPLIANCE - Navigating ISO 23908:2024 & EN ISO 23908:2025 Harmonization: What It Means for Your Combination Product Strategy
Murtaza Rana and Aurélie Rebuffet reflect on how a revised standard is an opportunity to reassess how sharps injury risks are addressed across product development, regulatory submissions, and lifecycle management
25 Years of Trust, Partnership & Progress
To Our Readers, Advertising Partners, and Industry Colleagues, When Drug Development & Delivery began in 2001, the pharmaceutical and life sciences landscape looked very different…
2026 Sustainable Drug Development & Delivery eBook: Pharma Needs A Risk-Based Strategy Toward Sustainability
As sustainability expectations continue to rise across the pharmaceutical industry, drug makers, CDMOs, and equipment suppliers are under increasing pressure to reduce waste, energy use, and environmental impact. Find out in this exclusive Drug Development & Delivery eBook how companies like Bespak have taken steps to support the scale of commercial-scale manufacturing of a low-carbon Pressurized Metered Dose Inhaler. Additionally, learn how Aptar Pharma Injectables division has undertaken an effort to identify the principal sources of emissions across its elastomeric closure solutions. Finally, a new sustainability report reveals what the pharma industry is doing particularly well – and not so well – in its sustainability endeavors.
2026 Nasal & Inhalation Drug Development & Delivery eBook: Drug Repurposing Creates New Market Opportunities
In this exclusive seventh annual nasal and inhalation eBook, Drug Development & Delivery highlights how these routes of administration are bringing new life to orphaned drugs and open new opportunities for treatment beyond pulmonary and respiratory diseases. We also explore the challenges of nose-to-brain delivery, next-generation propellants, overcoming the limitations of dry powder inhalers, and successful formulation strategies.
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.
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.
Mastering Analytics: LC-MS Analysis of Oligonucleotide Drugs
In this episode of Expert Insights, Drug Development & Delivery Managing Editor Cindy Dubin speaks with Dr. Melanie Zerulla-Wernitz, Head of Analytical Science Laboratory at Vetter, about the growing role of LC-MS in oligonucleotide characterization.
What Contamination Control Strategy (CCS) Means for Customer Confidence in Sterile Manufacturing
Contamination Control Strategy (CCS) shapes how sterile manufacturers and their suppliers demonstrate control over injectable drug products under Annex 1. In this video interview, Aptar Pharma’s Nicolas Voisin and Audrey Chardonnet explain what CCS means in daily operations, and how it translates into customer confidence.
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.
Four Myths About Embedded CMOs, Busted
Are your perceptions of the CMO marketplace serving your drug program—or holding it back? If you’re looking for a contract manufacturer to bring your therapy to market, you’re far from alone. Demand for manufacturing services is shaping the pharma Contract Manufacturing Industry, with analysts predicting a growth rate of nearly 7% per year until 2028. In such a competitive market, how should a project sponsor navigate the choice between one CMO and another? To find the answer, many sponsors begin by distinguishing between typical stand-alone CMOs and an embedded CMO that operates under a parent company—AbbVie, in the case of AbbVie Contract Manufacturing (AbbVie).
How Molecular Biology Technologies Are Transforming Discovery and Development
Advances in PCR, sequencing, automation, and molecular analysis are helping biopharma teams accelerate discovery, improve data quality, and reduce development risk. Thermo Fisher Scientific’s Dr. Anjali Shah discusses how integrated molecular biology workflows are evolving to support increasingly complex therapeutic modalities.
SPECTROSCOPY - High-Precision Tunable Laser Spectroscopy: A “Library-Based” Approach to Quantitative Bioprocess Analytics
The accuracy and speed of analytical measurements play a critical role in biopharmaceutical development and manufacturing. In particular, the ability to quantify both active pharmaceutical ingredients (APIs) and formulation excipients – such as buffers, amino acids, sugars, and surfactants – is essential for ensuring product quality, process consistency, and regulatory compliance.
COLD CHAIN SUSTAINABILITY - Cold Front: The Growing Need for Controlling Cold Storage Energy Costs
The pharmaceutical and biotech industries are not only one of the most prominent users of cold storage solutions today but are also one of the market’s most important growth drivers. Several factors, including the rise of temperature sensitive drugs, growing energy prices, and increasing regulatory scrutiny are inevitably compelling the pharmaceutical industry to consider its use of the global cold chain with sustainability in mind.
Monoclonal vs Polyclonal Antibody Production – Explained Step by Step
Antibody-based therapeutics have reshaped modern medicine. With demand soaring, choosing the appropriate production path can save months and millions.
According to Grand View Research, the global therapeutic antibody market will surpass US $2.21 billion by 2030.
Based on our expertise in monoclonal antibody production, let’s take a look at how each antibody type is produced, contrasts their timelines, costs, and use-cases, and ends with clear next steps to keep your project moving.
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WHITEPAPERS & WEBINARS
WHITEPAPER - Streamlined Product Development Leveraging Pharmaceutical Classification Models
A technology agnostic approach based on a fundamental understanding of API properties, a well-defined yet flexible target product profile, and a mindset for scalability and…
WEBINAR ON DEMAND - Heat Without Harm: The Reality of Hot Melt Extrusion Webinar
In a 2025 industry survey (1), 76% of respondents selected ‘risk of thermal degradation’ as a source of hesitation to pursue hot melt extrusion (HME). Concerns about heat-sensitive APIs frequently lead development teams to rule out HME early — often before conducting a thorough scientific evaluation of their formulation options.
But thermal risk is frequently overstated. In this on-demand webinar, Stefanie Hauck, Senior Director PDS&T Pharm. Tech. at AbbVie Contract Manufacturing, explains why many compounds initially considered unsuitable for HME can be successfully processed with the right expertise.
WHITEPAPER - Container Closure Integrity Issues in Cell & Gene Therapy Products
The cell and gene therapy (CGT) product market is expected to grow at a very high rate of around 20-30% per year over the next 10 years. Increasing number of approvals, expansion of target diseases, accelerated investment and innovation, and advent of aging population are the key factors for the growth.
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.
WHITEPAPER - 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 .
WHITEPAPER - 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.
MARKET NEWS & TRENDS
Company’s First AI AI-Generated Design Goes Into Human Studies
BigHat Biosciences, a clinical-stage, AI-driven protein therapeutics platform company, today announced that the first patient has been dosed in its Phase 1 clinical trial evaluating…
Potential New Target Identified for Cancer Cachexia Therapy
Researchers at Helmholtz Munich, the Heidelberg Faculty of Medicine at Heidelberg University, the German Center for Diabetes Research (DZD) and the Technical University of Munich…
First Patient Dosed in Veloxis Pharmaceuticals Phase 2 Trial of Pegrizeprument for the Prevention of Organ Rejection in Kidney Transplant Recipients
Veloxis Pharmaceuticals, Inc., a global specialty pharmaceutical company part of Asahi Kasei Corporation, today announced that the first participant has been dosed in its Phase…
Pfizer and BioNTech Receive FDA Approval for XFG-Adapted COVID-19 Vaccine
Pfizer Inc. and BioNTech say the FDA has approved the supplemental Biologics License Application (sBLA) for the companies’ 2026-2027 COVID-19 vaccine formula targeting the XFG…
FDA Approves First-of-a-Kind Drug for Rare Blood Disorder
The Food and Drug Administration today approved Takeda Pharmaceuticals’ Mimrylo (rusfertide), a new treatment for adults with polycythemia vera, a rare blood disorder that causes…
Lilly’s $2.87B Acquisition of Merida Biosciences Advances Treatments for Autoimmune and Allergic Diseases
Eli Lilly and Company and Merida Biosciences, Inc., a biotechnology company advancing a new class of precision therapeutics for serious autoimmune and allergic diseases, announced…
Evonik expands lipid-based drug delivery capabilities with new GMP manufacturing facility in Vancouver
Evonik is investing in a new GMP drug product manufacturing facility for lipid-based drug delivery in Vancouver, Canada. The facility will increase Evonik’s development and…
Centrix Pharma Solutions and University of Sussex partner to advance data-driven pharmaceutical development
Centrix Pharma Solutions, a UK-based Contract Development Manufacturing Organization (CDMO) with strong scientific and manufacturing expertise, has partnered with the University of Sussex on a…
McKesson Signs Agreement to Acquire Precision Medicine Group, LLC
McKesson Corporation announced today that it signed a definitive agreement to acquire Precision Medicine Group, LLC, a global provider of clinical research and biopharma commercialization…
Hovione Completes Expansion of Loures Tablet Manufacturing Center Adding Commercial-Scale Batch Tableting Capacity
LOURES, Portugal – Hovione, a globally-integrated specialist pharmaceutical CDMO, has completed expansion of the company’s tablet development and manufacturing center at its main global campus…
Aptar Active Material Science first use of Activ-Film technology with a commercialized capsule-based Dry Powder Inhalation (DPI) drug product.
Aptar Active Material Science, part of AptarGroup, Inc. and a global leader in active material science solutions, announced its first use of Activ-Film technology with…
FDA Approves IMAAVY (nipocalimab-aahu) for the treatment of warm autoimmune hemolytic anemia
The U.S. FDA approved IMAAVY (nipocalimab-aahu) for the treatment of warm autoimmune hemolytic anemia (wAIHA) - a rare, life-threatening autoantibody disease - in adults and pediatric…
Purdue small-molecule inhibitors shown to promote robust antitumor immunity
WEST LAFAYETTE, Ind. — Researchers in Purdue University’s College of Pharmacy have developed and validated a novel series of small-molecule inhibitors that promote antitumor immunity and hold…
Erasca Granted FDA Fast Track Designation for Pan-RAS Molecular Glue ERAS-0015
SAN DIEGO, -- Erasca, Inc. , a clinical-stage precision oncology company singularly focused on discovering, developing, and commercializing therapies for patients with RAS/MAPK pathway-driven cancers,…
Smithers Germany Medical Device Testing Lab Achieves ISO/IEC 17025 Accreditation
(Akron, Ohio, USA) — Smithers, a leading provider of testing, consulting, information, and compliance services, announces that its Germany Medical Device Testing laboratory is formally…
Evonik provides customers with Life Cycle Assessment data for selected EUDRAGIT polymers
Essen, Germany. Evonik now offers its customers cradle-to-gate LCA data for selected EUDRAGIT functional polymers. These results are derived from Evonik’s TÜV-certified LCA method. This…
Bespak Awarded Gold EcoVadis Sustainability Rating for its Holmes Chapel Site
Holmes Chapel, UK, Bespak, the specialist inhalation CDMO, has achieved a Gold EcoVadis sustainability rating for its Holmes Chapel site. The result places Bespak among…
Lonza Launches Rapid Custom Media Prototyping Service to Accelerate Early Bioprocess Development
Basel, Switzerland – Lonza, a leading contract development and manufacturing organization (CDMO), today announced its Rapid Media Prototyping Service (RaMP), giving biopharmaceutical companies faster access…
SGS enhances bioanalytical capacity with Saint-Benoît laboratory expansion
Baar – SGS, the world’s leading testing, inspection and certification company, has expanded its Saint-Benoît laboratory, a strategic site dedicated to pharmaceutical bioanalysis and drug…
Grifols announces Last Patient Last Visit in SPARTA, its Phase 3 Outcomes Study of Prolastin®-C in patients with emphysema due to alpha-1 antitrypsin deficiency
Barcelona, Spain, – Grifols, a global healthcare company and leading producer of plasma-derived medicines, today announced the completion of the clinical portion of SPARTA (Study of ProlAstin-C Randomized Therapy…
