The FDA has released a new draft guidance, Assessing the Irritation and Sensitization Potential of Transdermal and Topical Delivery Systems for ANDAs. The document is set to replace the 2023 version.
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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.
Modular suites with built-in contamination control streamline sterile manufacturing—supporting complex products, faster timelines, greater flexibility, less disruption, and scalable fill‑finish.
ARTICLES, APP NOTES, CASE STUDIES, & WHITE PAPERS
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Turning A "Brick Dust" Compound Into A Clinically Viable Oral FormulationAdvanced wet milling and particle stabilization improve solubility, enhance bioavailability, and support scalable manufacturing for complex oral drug development programs.
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Successful Tech Transfer Plans Ensured On-Time LaunchesSuccessful technology transfers require proactive engineering and rigorous assessments to address equipment challenges, protect product integrity, and keep launches on schedule.
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Managing Risks With Potent Pharmaceutical ProductsManufacturing potent medications safely requires specialized containment, toxicology expertise, and strict contamination controls to ensure compliance, product quality, and worker safety.
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![iStock-459537393-pill-softgel-capsule]( "Is Your API Right For A Soft Gel Capsule?")
Is Your API Right For A Soft Gel Capsule?Soft gel delivery systems can enhance bioavailability, enable controlled release, support combination dosing, and handle potent compounds while improving stability and patient adherence.
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How A CDMO Overcomes Soft Gel Formulation ChallengesSoftgel development demands careful control of shell properties, liquid fills, and stability. Overcoming formulation challenges improves drug delivery, bioavailability, and shelf life.
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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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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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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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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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DELIVERED BY DEGRAZIO
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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.
