Teams must assess the drug, the device, the manufacturing process, and the environment in which the product is used as an integrated system, not as separate parts.
- Advancing Multi-Pathology Disease-Modifying Therapy For Neurodegenerative Diseases
- Container Closure Systems For Biosimilars: Is There Regulatory Difference?
- Qualification And Validation Of Depyrogenation Tunnels And Autoclaves
- FDA Modernizes Container Closure Guidance: What Is Changing And Why It Matters
- Engineering Better ADCs, Part 2: Characterization, CMC, And More
- What Patients Actually Want From Connected Drug Delivery
- Beyond Connectivity: Where Digital Technologies Create Real Value In Drug Delivery
- Engineering Better ADCs, Part 1: MoA, Conjugation Chemistry, And More
ON-DEMAND WEBINARS
Watch to hear Steven Facer, Adare's Vice President of Business Development EU/ROW, discuss the challenges of pediatric oral solid dose manufacturing and how to overcome them.
Succeed in combination product development by understanding the risk factors that may arise and implementing mitigation strategies that will streamline the device development process.
Learn more about defining the spray drying process with an emphasis on specific enhancements to accommodate scale-up to commercial scale equipment of challenging applications or molecules.
Nanoparticle engineering enabled a 440 mg/mL trastuzumab suspension that clears viscosity and stability barriers limiting conventional high-dose subcutaneous biologics formulations.
ARTICLES, APP NOTES, CASE STUDIES, & WHITE PAPERS
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![GettyImages-1082257488-liquid-capsule-OSD]( "Liquid Capsule Manufacturing: What To Know")
Liquid Capsule Manufacturing: What To KnowCapsules surround a drug in an unflavored, solid barrier enclosure. This article focuses on liquid capsule manufacturing and its advantages.
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![Image 4]( "Minimizing Particulate Risk: Designing For Control")
Minimizing Particulate Risk: Designing For ControlEffective particulate control in aseptic fill/finish operations requires coordinated design decisions spanning airflow configuration, static mitigation, transport mechanisms, and closure handling.
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![west_production_102]( "Mechanical Engineering Design Process For Combination Products")
Mechanical Engineering Design Process For Combination ProductsMechanical engineering for combination drug-delivery devices demands more than good design — it requires data-driven risk management from specs through simulation. Learn how a structured phase approach ensures global manufacturing readiness.
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![Epigenetic therapies of the future_GettyImages-2203738408]( "Personalized Gene Therapy Is Here. The Next Challenge Is Manufacturing.")
Personalized Gene Therapy Is Here. The Next Challenge Is Manufacturing.By focusing on approved processes rather than products, the industry can deliver custom genetic therapies rapidly and reliably to patients with ultra-rare diseases.
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![pharma-partners-GettyImages-2182052451]( "The Benefits Of Transparent Pricing")
The Benefits Of Transparent PricingStreamline biopharma budgeting and expose hidden contract manufacturing fees. An all-inclusive pricing model ensures predictable partnerships from initial scale-up to commercial approval.
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![GettyImages-2190247072-laboratory-vials-analysis-scientist]( "Discussing Qualities Of A CDMO Redefining Innovation")
Discussing Qualities Of A CDMO Redefining InnovationEnsuring precision in fill/finish for large-volume devices is critical for performance. Discover the essential traits that redefine innovation and support patient-centric manufacturing solutions.
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![Artificial Intelligence (AI) Digital Concept GettyImages-1160995648]( "The Algorithm Is In: 5 Ways AI Is Transforming Medicine")
The Algorithm Is In: 5 Ways AI Is Transforming MedicineAI is transforming the medical field, offering innovative solutions to complex problems. Explore the potential of AI in revolutionizing healthcare and leveraging data to improve patient experiences.
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![Ypsomed's Dual-Engine Strategy For Success In China]( "Flying On Two Wings: Balancing Local Agility And Global Quality In China")
Flying On Two Wings: Balancing Local Agility And Global Quality In ChinaAs China expands its role in drug development, injectable therapy programs face new demands. Learn how manufacturers are scaling quality, devices, and production for global success.
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![West-NovaPure]( "Moving From Vial Systems To Prefilled Syringes And Autoinjector Systems")
Moving From Vial Systems To Prefilled Syringes And Autoinjector SystemsMoving from vial systems to prefilled syringes and autoinjector systems requires patient and caregiver needs, drug product requirements, system components, and performance.
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![GettyImages-1220131127-pill-medicine-patient]( "Opioid Reformulation Filed As A CMC Supplement In Less Than A Year")
Opioid Reformulation Filed As A CMC Supplement In Less Than A YearSome reformulation projects are more challenging than others. See how innovative processing equipment from Freund-Vector was leveraged to develop an efficient and effective solution.
TOM'S TAKES ON DRUG DELIVERY
TALKING WITH TOM VIDEOCASTS
Fran offers keen industry and technical insights exclusively on Drug Delivery Leader.
DELIVERED BY DEGRAZIO
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![Delivered _by _DeGrazio_Logo_Color_2]( "Container Closure Systems For Biosimilars: Is There Regulatory Difference?")
Container Closure Systems For Biosimilars: Is There Regulatory Difference?In this article, Fran DeGrazio discusses the FDA’s draft guidance on container closure systems for biosimilar products. She highlights key takeaways and offers recommendations on implications that developers of biosimilar pharmaceutical products should consider in areas such as quality, testing, and documentation.
EDITORIAL COLLECTIONS KNOWLEDGE CENTER
Our Editorial Collections examine today’s biggest scientific, operational, and patient-centered drug delivery issues. These collections help companies navigate complex development decisions with in-depth analysis, real-world examples, and guidance from industry experts.
