INJECTABLE DRUG DELIVERY ARTICLES
Formulation And Delivery Considerations For Cell And Gene Therapies
How can we ensure cell and gene therapies are truly transformative for patients? Success depends on the right combination of formulation, preparation, and delivery.
INJECTABLE DRUG DELIVERY VIDEOS
Explore primary packaging developed following well-established ICH principles for sustainable compliance and vial container closure systems for product development and commercial manufacturing needs.
Explore the challenges related to packaging of cell and gene therapy products and proven solutions to enable speed to market and compatibility, performance of packaging materials.
Explore some of the more challenging aspects surrounding in-use testing for parenteral delivery along with potential strategies to address these issues.
A review of the draft guidance and importance of component selection as it relates to establishing a risk-based approach and the role of the NovaPure product line in component selection.
INJECTABLE DRUG DELIVERY RESOURCES
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![BD Vystra - thigh-450x300-wide]( "De-Risking FDA Abbreviated New Drug Application (ANDA) Submissions: BD Vystra™ Disposable Pen For Semaglutide")
The BD Vystra™ Disposable Pen for Semaglutide is a generic drug-device combination, designed for usability and regulatory compliance, showing comparable performance to the reference device.
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![iStock-1087218874]( "Improved Biomanufacturing Processes And Drug Product Stability")
Improve upstream media for bioavailability and foam stability, downstream buffers for purification, and the formulation and final fill drug product stability with this highly interdisciplinary process.
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![West]( "Streamlining Primary Container And Device Selection With Predictive Calculations")
Expolore a theoretical approach to complement experimental approaches to more quickly select a packaging and delivery system for your drug product.
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![GettyImages-1371993517-syringe-vial-mask-vaccine-inject]( "A Lifecycle Management Strategy For Sterile Injectables")
Gain insight into the benefits and challenges of transferring a therapeutic compound from one aseptic injectable format to another.
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![Singota]( "Faster From Formulation To Fill/Finish")
Optimize your speed to clinic by securing a development and aseptic fill/finish partner to support your applications with the right manufacturing equipment, communications, and SOPs.
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![GettyImages-1284529278-syringe-pre-filled-PFS]( "New Perspectives On Accelerating Genetic Nanomedicines Through The Regulatory Pathway")
Discover how regulatory bodies are adopting a risk-based approach to address the unique challenges of genetic nanomedicines, and stakeholder engagement is essential.
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![DD 2 - 2mL_10mL_Vials_Tubs_Capped]( "Safeguarding Cell Therapy Cryopreservation: Primary Containers")
Review different aspects of container selection from the perspective of cryopreservation that are may be overlooked but critical for the quality of cell therapy drug products.
INJECTABLE DRUG DELIVERY SOLUTIONS
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![West_GC_App_PFS 1 mL 1_3mL Plungers 003 WestPharm_2_1ml_1-3ml_Plungers LR]( "Prefilled Syringe Plungers: Mitigate Against Risks To Improve Success")
From start to finish, NovaPure components have been designed and manufactured using Quality by Design principles to mitigate risk for the patient.
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![iStock-493302504-scientist-lab-development]( "Pre-Formulation And Material Sciences")
Our formulation development and material sciences experts have over 30 years’ experience in pre-formulation and solid state characterization.
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![VFM]( "Pharmaceutical Vial Filling Equipment: VFM")
VFM automatic filling and stoppering machines are designed for injectable solutions in vials.
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![Ampoule Aseptic Filling GettyImages-1490244818]( "Pre-Filled Precision In Every Dose")
More than a service provider, we act as an extension of your team, accelerating your drug’s journey from late-stage clinical development to commercial supply.
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![BD]( "Easy-To-Use 1 mL Disposable Autoinjector")
BD Physioject™ 1 mL Disposable Autoinjector is an easy-to-use autoinjector designed to deliver fixed dose injections subcutaneously.
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![GettyImages-2176475661 tabet press, pharma manufacturing]( "Streamlining The Generic Combination Device Design Assessment Process")
A new six-phase assessment process simplifies regulatory approval for generic drug-device combination products, reducing costs and timelines while maintaining safety, effectiveness, and substitutability with reference-listed drugs.
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![GettyImages-1171312168-lab-development-research]( "A CDMO With Oral Solid Dose And Sterile Injectable Expertise")
Societal specializes in modified-release formulations, including those for high potent and DEA controlled substances.
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![ASEPTiCell]( "Isolator Barrier Pharmaceutical Aseptic Filling Systems")
ASEPTiCell is integrated with isolator-barrier technologies to fully enclose and tightly control the aseptic environment for ideal conditions for processing sterile drug products. The system can be configured with a Restricted Access Barrier System (RABS) or an aseptic isolator to provide uninterrupted aseptic conditions during production. With isolator integrated systems, the ASEPTiCell is completely compatible with repeated in-situ bio-decontamination using hydrogen peroxide to further enhance the sterility assurance of the system.
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![GettyImages-1435081495-Self-Injector_Auto-Injector]( "Autoinjector For Deep Intramuscular Delivery")
Intramuscular
0.5 - 3 mlArQ® - Vita can achieve large volume, deep intramuscular delivery, making it the ideal platform to deliver medication for chronic conditions. Built around Oval’s polymeric primary drug container technology, we can create a device that is small and simple to use, whilst housing the correct length needle to achieve consistent intramuscular delivery for your patient population.
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![Stevanato Group - Aidaptus]( "Aidaptus® Manufacturing")
We are the exclusive manufacturing partner for this innovative auto-injector platform.
