INJECTABLE DRUG DELIVERY ARTICLES
In Vivo's Biggest Threat — Comparison To Old Models
In vivo CAR-T is not simply ex vivo without a manufacturing step. It is a different modality that relies on biological systems to regulate outcomes.
INJECTABLE DRUG DELIVERY RESOURCES
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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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Kevin Smyth, a biochemical engineer with 30 years of experience in the pharmaceutical industry, offers insights and expertise in working with firms to understand what regulators seek to meet new standards.
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BD’s Vystra™ Disposable Pen for Liraglutide 3.0 mg demonstrated comparable usability to the reference device, helping de-risk ANDA submissions through proactive human factors evaluation.
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Explore how to approach the transition of migrating from a vial to a syringe or cartridge, the necessary compatibility testing, and the stresses on the bulk product during formulation and filling.
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To mitigate inherent risks like inconsistent dosing, user error, and low adoption due to complex usage procedures, technological innovation in delivery devices is best guided by lessons from the past, including user feedback and follow-on learnings from market data.
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The rising incidence and severity of obesity have amplified a therapeutic need in healthcare. Read more about Dr. Srinivasan Shanmugam discussing the challenges and impact of GLP-1 analogs.
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Explore how the widespread adoption of autoinjectors is transforming the biopharmaceutical industry's approach to drug delivery, offering precise dosing, patient adherence, and safety.
INJECTABLE DRUG DELIVERY SOLUTIONS
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West’s DeltaCube™ Modeling Platform was developed to help customers mitigate issues during the early phase of their component selection.
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Experienced CDMOs will implement a cGMP aseptic manufacturing and sterile fill-finish policy to improve drug bioavailability. Aseptic fill-finish is a process in which the drug product, container, and container closure are sterilized separately and then integrated. Combining the drug, container, and closure in a clean room using special equipment that is self-contained in a sterile environment meets FDA guidelines related to cGMP.
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Formulation and aseptic filling solutions are crucial at every stage of development. Consider a manufacturing partner who can address every challenge on the path from pre-clinical programs to commercialization.
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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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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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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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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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Analyze a family of fill/finish solutions that offers a complete, configurable solution for biopharmas and CDMOs looking to maximize drug product recovery.
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Developing combination products requires navigating complex regulations. A solution that combines packaging, delivery systems, and expert support can accelerate your path to market and reduce risk.
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We are the exclusive manufacturing partner for this innovative auto-injector platform.