In this article, Fran DeGrazio reflects on the significance of the FDA Draft Guidance on Container Closure Systems, the first update since 1999. DeGrazio places the CCS draft guidance in the current context of science-based and risk-based product development for combination products and other injectable drug product delivery systems.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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Explore the pros and cons of marketed amorphous solid dispersions with so-far unpublished data as well as a green alternative to ASDs: best-in-class nanotechnology to manufacture nanocrystals.
By reducing the size of drug particles, nanoforming offers new opportunities — from increased bioavailability to sustained drug delivery. Discover the potential benefits supported by case studies.
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.
Delve into the intricacies of combination products and the regulatory expectations, including risk-based determination, evaluation, and documentation approaches for performance requirements.
ARTICLES, APP NOTES, CASE STUDIES, & WHITE PAPERS
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Containment Solutions To Help Emerging Biologic CompaniesSet up your small company for long-term success using packaging containment offerings and services to help mitigate risks and speed up your time to market.
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Prefillable Syringe Plungers: A Solution For Low Temperature StorageReview a study with 1 mL long glass and polymer-based syringes and with 2.25 mL glass syringes. Explore the impacts on plunger movement, container closure integrity, and break loose and extrusion force.
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Small Is Powerful And SustainedAdvances in sustained-release drug delivery could improve efficiency and consistency in drug release, manifesting real-life advantages for patients in the form of enhanced accessibility and compliance.
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Sustainability Considerations For Drug Delivery Device End-To-End SolutionsLearn how to address the gradual unlinking of economic activity from the consumption of finite resources and the removal of waste to support and help prevent a global climate catastrophe.
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How To Find The Right Balance In Cell Therapy ManufacturingThe choice between closed and open fill/finish for cell therapy drug products ultimately involves a careful balance between safety, accessibility, efficacy, and the type of cell type used.
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Integrated First-In-Human Services To Streamline End-To-End Development And ManufacturingLonza’s SimpliFiH®️ Solutions offering is designed to simplify and accelerate the development pathway, even for APIs with challenging properties, such as low aqueous solubility and poor bioavailability.
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Beyond The Battery: Powering the Next Generation Of Active ImplantsActive implants are pushing past battery limits as energy‑harvesting taps motion, heat, and biochemical signals. Hybrid systems could shrink devices and enable longer‑lasting, self‑powered implants.
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High-Throughput Platform Propels Gene Editing Therapy ResearchExplore the potential of polymeric nanoparticles (PNPs) as an alternative to viral vectors. PNPs offer design flexibility, enabling larger payloads, targeted release, and minimized side effects.
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Design And Packaging Advantages For Cell And Gene Therapy DrugsWith the increasing demand for cell and gene therapies, Crystal Zenith nested vials can help the biopharma industry overcome the challenges of scaling up manufacturing and logistics.
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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.
