The field has evolved considerably in antibody–drug conjugate (ADC) science. In this first article of a two-part series, let's discuss how to engineer better ADCs, covering MoA, conjugation chemistry, and more.
- Using Low-Intensity Focused Ultrasound To Open The Blood–Brain Barrier
- Engineering Medical Devices To Improve Oral Delivery Of Biopharmaceuticals
- Oral Combination Therapies: Navigating Development Complexities
- Beyond GalNAc: Reengineering siRNA For Extrahepatic Delivery
- Engineering CAR T Cells With mRNA-LNPs: Applying Oncology Learnings To Allergic Diseases
- The Future Of Cancer Drug Discovery Is Targeted Immune Activation
- Part 4 cGMP Summaries For Combination Products: Uncovering FDA Expectations
- Unpacking The FDA Draft Guidance On Container Closure Systems
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If you are in the process of developing a complex or sensitive injectable drug, learn about containment solutions to mitigate your risks and help you get your drug to the patient faster.
Gain valuable insights into key considerations when selecting lipid excipients for LNP formulations and the process development steps necessary to advance them to GMP manufacturing and clinical trials.
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Explore primary packaging developed following well-established ICH principles for sustainable compliance and vial container closure systems for product development and commercial manufacturing needs.
ARTICLES, APP NOTES, CASE STUDIES, & WHITE PAPERS
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![GettyImages-1027752634]( "Selecting An Alternative Coating Technology To Silicone Oil For Prefillable Syringes")
Selecting An Alternative Coating Technology To Silicone Oil For Prefillable SyringesThe challenges of silicone-oil lubrication and the growing trend for more viscous, protein-based drugs are now leading pharma and biotech companies to investigate alternative solutions.
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![West-PO 3 - GCApp]( "Meeting Annex 1: A Proactive Approach To Regulatory Compliance")
Meeting Annex 1: A Proactive Approach To Regulatory ComplianceIt was imperative for a large European CMO producing multiple biologics to select the right product quality and value for each customer to comply with the August 2023 EU GMP Annex 1 revision.
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![GettyImages-2166352840-scientists-in-lab-with-computer-screen]( "Advancing Biopsy Device Performance Through Precision Overmolding And Assembly")
Advancing Biopsy Device Performance Through Precision Overmolding And AssemblyEarly design alignment resolves tolerance stack-ups, controls mechanical variation, and maintains sample accuracy. Navigating process validation and automated assembly accelerates commercialization.
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![GettyImages-1206035004-spectroscopy-lab]( "Application Of Nano-Emulsion Technology To Address Unmet Medical Needs: A Case Study Of Clopidogrel IV By 505(b)(2) Pathway")
Application Of Nano-Emulsion Technology To Address Unmet Medical Needs: A Case Study Of Clopidogrel IV By 505(b)(2) PathwayReview a process where the insoluble and unstable free-base form of clopidogrel is converted to a form with acceptable drug loading and is protected from chemical degradation.
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![iStock-1191001266-tablet-pill]( "How Approved Drugs Have Evolved Since The '70s")
How Approved Drugs Have Evolved Since The '70sDrugs have become more lipophilic and complex in structure over time. Innovative strategies are needed to improve the bioavailability of these new drugs.
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![GettyImages-2151620900 antibody, IgG]( "CMO As Partners For ADC Process Development, Scale-Up, Optimization")
CMO As Partners For ADC Process Development, Scale-Up, OptimizationADC programs can accelerate through clinical phases rapidly, making early preparation for commercial launch imperative. It's sensible to partner with a CMO with a strong biologics foundation.
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![Vials pharma manufacturing GettyImages-618518692]( "Comparing Vial Container Closure Systems")
Comparing Vial Container Closure SystemsExamine a case study where two 20mm vial CCSs were compared using the DeltaCube™ Modeling Platform and experimentally show the link between prediction and real performance.
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![GettyImages-533059254-mRNA_DNA_gene_therapy]( "Combining Gene Therapies, Carrier Systems, And Medical Devices")
Combining Gene Therapies, Carrier Systems, And Medical DevicesDrug delivery is one of the most significant obstacles to advancing gene therapies. Examine the opportunities for success in combining novel medical devices to improve delivery of gene therapies.
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![BD Medical-1]( "Gliding Towards De-Risked Combination Product Development")
Gliding Towards De-Risked Combination Product DevelopmentLearn about the critical role plunger stoppers play in determining a combination drug product's exposure to extractables and leachables.
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![Machine Converyor With Glass Vials GettyImages-498492002]( "Data-Driven Approach Optimizes Robust, Scalable Lyophilization Process")
Data-Driven Approach Optimizes Robust, Scalable Lyophilization ProcessSelecting the right manufacturing partner with appropriate lyophilization expertise, experience, and analytical capabilities can speed drug development and expedite time to market for lyophilized drugs.
TOM'S TAKES ON DRUG DELIVERY
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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]( "Unpacking The FDA Draft Guidance On Container Closure Systems")
Unpacking The FDA Draft Guidance On Container Closure SystemsIn this article, Fran DeGrazio reflects on the significance of the FDA Draft Guidance on Container Closure Systems, the first update since 1999. DeGrazio places the CCS draft guidance in the current context of science-based and risk-based product development for combination products and other injectable drug product delivery systems. She also addresses the integration of CCS guidance into the development organization’s QMS (Quality Management System).
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Why Human Factors Are Critical To Drug Delivery Device Success
In today’s highly competitive biopharma market, successful therapies prioritize the patient experience. Increasingly, patients expect to receive advanced therapies at home or in decentralized care settings, which require delivery methods that are easy to use and comfortable.
This collection explores how drug delivery teams can incorporate patient-centricity across development, from early human factors strategies to modality selection, ensuring safe, effective therapies that translate to real-world care.
