INJECTABLE DRUG DELIVERY ARTICLES
Can We Cure Diabetes?
We caught up with Minutia CEO Katy Digovich to discuss engineered iPSC-derived islets intended for transplantation into the forearm, which could make a functional cure for insulin-dependent diabetes broadly accessible.
INJECTABLE DRUG DELIVERY RESOURCES
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A study assessing the stability of vials aimed to determine if the vial material had any influence on the viral titer and particle counts of the AAV serotypes.
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Physiologically based pharmacokinetic modeling is a powerful tool for clinical trial design that can be leveraged alongside early development experiments to reduce costs and accelerate timelines.
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Examine the results of two, two-year studies that indicate good container closure integrity performance that can be achieved with stoppers of a given elastomer, independent of configuration.
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As drug products increase in complexity, become more specialized, and trend towards self-administration, it is more important than ever to have a reliable drug closure system.
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Complex drug product formulations are more common, so it is imperative to have a deeper knowledge of extractables to understand risks associated with potential interactions between packaging and product.
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Demonstrating the compatibility of any material in contact with drug product throughout its lifecycle (manufacture, containment, and delivery) is a necessity for a regulatory submission.
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A customer experienced expensive project delays when they selected their “tried and tested” large volume, glass syringe system to package a drug to be used in an auto-injector for self-administration.
INJECTABLE DRUG DELIVERY SOLUTIONS
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Capabilities that improve efficiency and accelerate development.
B. Braun's OEM Division offers a variety of in-house molding capabilities including injection molding, insert molding and over molding. They own a primary 400,000-square-foot U.S. plant that includes a 16,500-square-foot ISO Class 8 molding facility housing some of B. Braun’s 80 injection molding presses, which range from 55-330 tons.
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Emergency‑readiness programs strengthen response with dependable countermeasures, rapid‑action tools, and decades of expertise supporting teams facing chemical, biological, and other high‑risk threats.
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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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Integrated device assembly, labeling, and packaging solutions streamline pharma delivery, ensuring compliance, scalability, and patient-centric design from clinical trials to commercial production.
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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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Our system is ideally suited for the production of pre-clinical, clinical and niche commercial injectable products in vial, syringe, and cartridge formats.
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We are the exclusive manufacturing partner for this innovative auto-injector platform.
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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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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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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.