INJECTABLE DRUG DELIVERY ARTICLES
Antibody–Oligonucleotide Conjugates, Part 4: Regulatory Considerations And Future Directions
This last article of the author's series on AOCs reveals regulatory perspective, analytical opportunities, the emergence of molecular quality by design, and the CMC challenges to address with future work.
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A review of the draft guidance and importance of component selection as it relates to establishing a risk-based approach and the role of the NovaPure product line in component selection.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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![West]( "Viral Vector Based Gene Therapy Drug Products: The Right Primary Container")
Explore the major considerations for an ideal primary container for viral vector-based gene therapy drug products and the existing and new solutions in this space.
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![BD2]( "Leveraging Autoinjector Innovation To De-Risk Biosimilar Development")
Discover how a biopharmaceutical company can de-risk the launch process by choosing a suitable autoinjector technology and partner.
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![GettyImages-1453524887-scientist-in-lab-with-computer-and-microscope]( "POC Diagnostics: 4 Considerations For Bridging The Gap From Development To Commercialization")
Scaling point-of-care diagnostics requires integrating microfluidics, chemistry, and automated assembly early in development. Aligning these pillars reduces risk and speeds time-to-market.
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![USP_Article_Picture_2]( "A Smooth Transition To USP <382> With Established Expertise")
A new regulatory chapter requires holistic, real‑world testing of injectable systems, mandating full‑system validation with actual drug products and prioritizing patient‑centric performance and safety.
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![GettyImages-2166352840-scientists-in-lab-with-computer-screen]( "Advancing Biopsy Device Performance Through Precision Overmolding And Assembly")
Early design alignment resolves tolerance stack-ups, controls mechanical variation, and maintains sample accuracy. Navigating process validation and automated assembly accelerates commercialization.
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![GettyImages-1157329320]( "Single Source Partner: Seamless Approach To Deliver World-Class Treatment")
Growing demand for high-value, complex therapies requires the right containment and delivery systems: solutions that offer superior quality and patient comfort while meeting stringent regulatory requirements.
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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.
INJECTABLE DRUG DELIVERY SOLUTIONS
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![Automated Sys Of Tacome Product]( "Pharmaceutical Aseptic Filling Equipment")
AST’s ASEPTiCell® and GENiSYS® systems combine industry-proven technologies such as robotics and isolator-barrier systems to provide flexible pharmaceutical aseptic filling and closing of ready-to-use vials, syringes, and cartridges with a single machine. These innovative platforms use a modular design approach to provide a truly adaptive system with the capabilities and features necessary for cGMP production of clinical and commercial sterile injectable products.
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![BD_Physioject_IMG_3332-450x300]( "BD Physioject™ Disposable Autoinjector")
BD Physioject™ Disposable Autoinjector offers a proven, user-friendly platform for self-injection, enhancing patient comfort, safety, and adherence across multiple chronic disease treatments globally.
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![StavanatoGroup-Vertiva On-Body Delivery System]( "Highly Flexible And Customizable On-Body Delivery System Platform")
Learn how Vertiva™ can enable delivery of micro-precision basal doses and full-content bolus injections, resulting in a highly flexible, customizable platform suitable for a wide range of therapies.
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![iStock-1214764688-scientist-lab-analyze-research]( "Analytical And Testing Services")
As part of Stevanato Group’s commitment to R&D, our analytical testing facilities focus on investigating physico-chemical properties of primary packaging materials and components and studying the interactions between container closure system and drugs. Stevanato Group relies on a multi-disciplinary team of highly skilled professionals, including, scientists, engineers, pharmaceutical chemists and biotechnologists. Their knowledge and experience covers a range of specialized areas including container closure systems and drug-delivery devices.
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![Clinical Excellence – From Molecule To Milestone_Ypsomed]( "Clinical Excellence – From Molecule To Milestone")
Ypsomed accelerates clinical progress by reducing barriers across clinical development, enabling earlier study readiness, greater visibility and more informed decisions.
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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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![GettyImages-1964958878 glucose monitor wearables patient doctor]( "BD Libertas™ Wearable Injector")
A wearable subcutaneous injector is being developed to support delivery of large‑volume, complex biologic therapies, expanding options for patients needing advanced at‑home administration.
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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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![BIMI]( "Aseptic Filling System For Pharmaceuticals: BI-MI")
Rotary filling, stoppering/tip placement/pump inserting and crimping or closing machine for bottles and vials up to 6000 u/h. The system is compatible with RABs or isolator enclosures. The system is able to work with stainless steel or ceramic rotary piston pumps or peristaltic pumps. Systems are available for manual or semi-automatic debagging, manual, semi-automatic or automatic delidding for pre-sterilized glass as well as cleanroom unscrambler’s for ophthalmic containers. Systems are 21 CFR Part 11 and audit trail compatible.
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![I01_Labs 173_WestPharm_Direct 113018-143]( "Don't Just Launch Your Molecule, Protect It!")
Accelerate your path to market with integrated support to streamline processes, reduce delays, and deliver safe, user-friendly drug-delivery solutions.
