In this article, Fran DeGrazio reflects on the significance of the FDA Draft Guidance on Container Closure Systems, the first update since 1999. DeGrazio places the CCS draft guidance in the current context of science-based and risk-based product development for combination products and other injectable drug product delivery systems.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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Gain confidence in your container closure system selection by utilizing a stepwise and data-driven approach to predicting and verifying container closure integrity.
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.
Process parameter and quality attribute relationships, including those for typical pre- and post-ASD unit operations, will be explored in the context of real-world examples.
Explore how our on-body delivery system supports high-volume biologic delivery by balancing usability, patient needs, and sustainability through research-driven design.
ARTICLES, APP NOTES, CASE STUDIES, & WHITE PAPERS
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![West]( "Vial Containment Systems For Gene And Cell Therapies")
Vial Containment Systems For Gene And Cell TherapiesCZ vial-stopper-seal combinations offer a viable solution for the challenges associated with low-temperature storage of cell therapy drug products.
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![Stevanato]( "Overcoming A Failed Design Verification Test For Your Delivery Device")
Overcoming A Failed Design Verification Test For Your Delivery DeviceIf a drug delivery device fails a design verification test, the consequences can be lost revenue for the pharma company and delays for patients. Explore how to eliminate design verification failure.
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![GettyImages-1311518492-vaccine-vial]( "A Glass Package Designed Specifically for Pharmaceutical Use")
A Glass Package Designed Specifically for Pharmaceutical UseA comprehensive solution for multiple glass quality issues that affect drug products is essential to avoid costly delays and drug product recalls, all while increasing patient safety.
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![thinkstock_pharma_manufacturing_450x3001]( "Parenteral Packaging And Delivery Systems: Container Closure Integrity")
Parenteral Packaging And Delivery Systems: Container Closure IntegrityReview the chapter, USP <1207> Package Integrity Evaluation – Sterile Products, which covers CCI and different methods of selection and validation.
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![GettyImages-1334686671-cold-chain-cryopreservation-logistics]( "Overcoming The Challenge Of Maintaining Sterility At Low Temperature Storage")
Overcoming The Challenge Of Maintaining Sterility At Low Temperature StorageLearn about a biotech company with a recently approved gene therapy product that needed to select a packaging solution to meet their needs for storage at low temperatures and still get to market quickly.
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![GettyImages-1302254900_nasal anatomy]( "White Paper: Nasal Delivery Of Spray Dried Biologics: Opportunities And Challenges")
White Paper: Nasal Delivery Of Spray Dried Biologics: Opportunities And ChallengesExplore the potential of spray-dried nasal formulations for biologics to achieve excellent stability and targeted delivery, paving the way for innovative and effective therapeutic solutions.
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![Guidelines For Selecting A Strategic Partner For Your Combination Product]( "Selecting A Strategic Partner For Your Combination Product")
Selecting A Strategic Partner For Your Combination ProductIt is imperative to choose an experienced partner that can ensure the highest quality products, minimize supply chain disruptions, and efficiently bring safe, effective drug products to patients.
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![West-BIO 1 - 88_NovaPureSyringes_0922]( "Achieving EU GMP Annex 1 Compliance For Contamination Control")
Achieving EU GMP Annex 1 Compliance For Contamination ControlGain insight into three areas that have been key in ensuring a robust contamination control strategy to help ensure compliance with the updated Annex 1 regulation: planning, people, and products.
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![gettyimages-1305313838-170667a]( "Ophthalmic Formulation Development: Inside Ophthalmic Preparation")
Ophthalmic Formulation Development: Inside Ophthalmic PreparationUnderstand why the demand for CDMOs with experience in the formulation of ophthalmic products is on the rise.
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![Compliance GettyImages-1212446127]( "Compliance Considerations For Emergency-Use Delivery Systems")
Compliance Considerations For Emergency-Use Delivery SystemsBecause auto-injectors are typically the delivery device of choice for emergency medications, they come with increased scrutiny from regulatory bodies regarding their safety and effectiveness.
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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.
