This last article of the author's series on AOCs reveals regulatory perspective, analytical opportunities, the emergence of molecular quality by design, and the CMC challenges to address with future work.
- Antibody–Oligonucleotide Conjugates, Part 3: Analytical Control
- Designing For Precision: How Delivery Is Shaping Cancer Treatment
- Antibody–Oligonucleotide Conjugates, Part 2: Manufacturing
- Intratumoral Treatment Of Cancer: After Many Prior Attempts, Has The Time Finally Come?
- Crossing The Uncrossable: Skin Biology For The Delivery Of Peptide And Protein Therapeutics
- When The Adhesive Becomes The Drug Delivery System
- Antibody–Oligonucleotide Conjugates, Part 1: Approaching Your AOC Development Plan
- Drug–Device Combination Products: Bridging Formulation, Device, And Manufacturing Decisions
ON-DEMAND WEBINARS
A practical framework for planning and justifying design verification programs for prefillable syringes, covering test selection, acceptance criteria, and sample-size rationale within a risk-based approach.
Nanoparticle engineering enabled a 440 mg/mL trastuzumab suspension that clears viscosity and stability barriers limiting conventional high-dose subcutaneous biologics formulations.
Explore an integrated workflow for targeted lipid nanoparticle development, covering ligand conjugation, candidate screening, and scalable manufacturing for cell-specific nucleic acid delivery.
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ARTICLES, APP NOTES, CASE STUDIES, & WHITE PAPERS
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![scientist in lab discussing research-GettyImages-2194013442]( "Ensuring Business Continuity In Your Pharmaceutical Commercial Supply")
Ensuring Business Continuity In Your Pharmaceutical Commercial SupplyDrug shortages demand resilient supply chains and strategic partnerships. Learn how experienced manufacturers help mitigate risks and ensure reliable supply.
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![drug-formulation-GettyImages-155282091]( "Oral Solutions & Suspensions: The Art Of Pharmacy")
Oral Solutions & Suspensions: The Art Of PharmacyOral liquid formulations improve accessibility and dosing flexibility. Learn how developers overcome stability, taste-masking, and manufacturing challenges.
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![Drug R-D_GettyImages-1483266787]( "Creating A New Dosage Form From An Approved Drug For A New Rare Disease")
Creating A New Dosage Form From An Approved Drug For A New Rare DiseaseAdvancing approved drugs into new indications requires smart formulation, strong quality controls, and regulatory expertise to overcome challenges and accelerate patient access.
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![drug-production-small-mole-GettyImages-2278072672]( "10 Qualities Your CDMO Should Have For An Oral Dose Tech Transfer")
10 Qualities Your CDMO Should Have For An Oral Dose Tech TransferChoose a manufacturing partner that supports every development phase with regulatory expertise, supply chain resilience, and formulation know-how.
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![GettyImages-2194013542-scientists-smiling-in-lab-discussing]( "Advancing The Development Of Syringe-Device Combinations")
Advancing The Development Of Syringe-Device CombinationsDefining the design for syringe-autoinjector pairings early, through shared compatibility testing, can reduce integration risk for high-viscosity biologics intended for self-administration at home.
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![GettyImages-1185624320-scientist-lab-smiling]( "Redefining Patient-Centric Drug Delivery")
Redefining Patient-Centric Drug DeliveryPreloaded on-body delivery systems reduce user error risks during treatment, while patient preference data supports simpler, more reliable home administration.
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![Why Early Device Decisions Matter How Immunovant Accelerated Its Clinical Program]( "Why Early Device Decisions Matter: How Immunovant Accelerated Its Program")
Why Early Device Decisions Matter: How Immunovant Accelerated Its ProgramDeferring autoinjector selection can seem to preserve flexibility, yet it often moves constraints downstream. Integrating the device during Phase IIb changed one program's timeline and removed bridging work.
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![For The Record How Past Experience Enables Future Success_Ypsomed]( "For The Record: How Past Experience Enables Future Success")
For The Record: How Past Experience Enables Future SuccessLaunch counts and years in business prove a partner has delivered, but the better question is what was learned along the way and how much carries forward.
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![Female researcher analyzing scientific samples-GettyImages-2231025177]( "Navigating The Analytical Challenges Of Complex ADCs")
Navigating The Analytical Challenges Of Complex ADCsAntibody drug conjugates are expanding to deliver diverse therapeutic payloads. Advanced analytical strategies are required to characterize these evolving platforms.
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![manufacturing-cmo-bio-aspetic-GettyImages-2277115525]( "Getting Ahead Of PFAS Risk In Pharmaceutical Manufacturing")
Getting Ahead Of PFAS Risk In Pharmaceutical ManufacturingPharma can’t simply eliminate essential PFAS uses. A phased, risk-based strategy can address footprint, exposure, and supply risks amid regulatory uncertainty.
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.
