INJECTABLE DRUG DELIVERY ARTICLES
7 Management Strategies For Combination Product Regulatory Success
In this article, Fran DeGrazio lays out best practices for biopharma executive leadership and non-technical managers to sustain regulatory momentum for their combination product development and commercialization. Fran points to cross-functional collaboration, quality management systems, regulatory documentation, and post-market surveillance as keys to drug delivery product success.
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A review of the draft guidance and importance of component selection as it relates to establishing a risk-based approach and the role of the NovaPure product line in component selection.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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![istock1087218874-lab-drug]( "Lyophilization vs. Liquid Formation: Why Lyo Offers Advantages")
Lyophilization offers some alluring advantages in today’s complex market, but its challenges require innovation and expertise to surmount.
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![GettyImages-155373764-cryopreservation-cold-chain]( "Vials Vs. Cryobags For Cryopreservation Of Therapeutically Relevant T Cells")
Explore how COP 50 mL vials could serve as a basis for cell therapies and storage solution to help facilitate the manufacture and commercialization of cell products.
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![GettyImages-136640925-vial-vaccine]( "CDMO Collaboration: The Foundation For Sterile Injectable Success")
Discover how an experienced and adaptable CDMO can provide tailored support to biotechs and pharma companies of all sizes, ensuring seamless sterile injectable development and manufacturing without compromising quality or safety.
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![Compliance GettyImages-1348548209]( "Annex 1 – The Brave New World Of Regulatory Compliance")
The revision to Annex 1 will become effective in August 2023. Explore the major changes and considerations along with the next steps to achieve Annex 1 Regulatory compliance.
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![West1]( "Prefillable Syringe Plungers: A Solution For Low Temperature Storage")
Review 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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![GettyImages-1335033345-cell-gene]( "How To Find The Right Balance In Cell Therapy Manufacturing")
The 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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![Stevanato Group - Autoinjector Assembly Feature]( "How A Flexible Approach To Autoinjector Assembly Can Be Advantageous")
Examine how a flexible, scalable, and efficient solution for the assembly of autoinjectors can help you stay ahead of the competition and meet the demands of an ever-changing industry.
INJECTABLE DRUG DELIVERY SOLUTIONS
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![C&G 2 - GCApp_MG (person picking up container)]( "Early Drug Development Made Easy With Small Quantities")
Why take the risk of selecting individual components that may not work well together? The West Ready Pack™ containment system, with proven container closure integrity, provides risk mitigation, convenience, and small quantities.
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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-1435081495-Self-Injector_Auto-Injector]( "Transforming Drug Delivery")
Learn how our team of scientists, engineers, and human-centered designers, as well as our world-class facilities, empower us to confidently guide your product toward a successful market launch.
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![Lipid Nanoparticles GettyImages-1437855772]( "Non-Viral Gene Delivery (NVGD) Using Polymeric-Nano Particles")
Examine a NVGD platform that tackles the primary obstacle hindering gene editing therapies: efficient delivery. Utilizing engineered nanoparticles, the platform overcomes limitations associated with payload size.
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![GettyImages-879828000-lab-cell-microscope]( "Analytical Services")
As part of Stevanato Group’s commitment to R&D, our analytical testing sites focus on investigating the physico-chemical properties and interactions of primary packaging materials and drug products.
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![BO 3 - GC_App_CZ Syringe and Vials_0171_RGB]( "Modeling Platform To De-Risk Container-Closure Selection")
West’s DeltaCube™ Modeling Platform was developed to help customers mitigate issues during the early phase of their component selection.
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![Pharma-Aseptic]( "Pharmaceutical Aseptic Filling Systems For Sterile Injectables")
The injectables market is a very demanding market, with high standard requirements. i-Dositecno is offering a very high standard solution for medium and low-speed solutions with very high requirements. Our speed range covers till 9.000u/h. In this product range, we can offer maximum benefits like Isolators for high containment solutions, oRAB’s and cRAB's, IPC control with check weighing of 100% of the production, CFR 21 part 11 compliance, and smooth and accurate production.
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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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![BD-xtraflow-]( "Glass Prefillable Syringe Solution Delivering Complex Biologics")
BD Neopak™ XtraFlow™ Glass Prefillable Syringe solution leverages 8 mm needle length in combination with thin wall cannula to reduce pressure drop and enhance flow.
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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.
