INJECTABLE DRUG DELIVERY ARTICLES
Organic Impurities: New Draft ICH Q3E Guidance For Leachables And Extractables
A new draft guidance document from ICH, issued jointly with the EMA, adopts the position that the assessment of leachables and extractables requires a holistic framework for risk evaluation.
INJECTABLE DRUG DELIVERY RESOURCES
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Because auto-injectors are typically the delivery device of choice for emergency medications, they come with increased scrutiny from regulatory bodies regarding their safety and effectiveness.
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Oligonucleotide therapies offer precise treatments for genetic disorders and chronic diseases. They face unique regulatory challenges but hold great promise, especially when combined with FDA engagement.
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Explore the challenges faced in administering highly viscous biologics to patients via subcutaneous injection and how new special thin-wall needles are able to tackle them.
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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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Explore a summary of the FDA’s recent draft guidance “Inspection of Injectable Products for Visible Particulates” and how it applies to components.
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For drug nanosuspensions, parameters like stabilizer concentration, drug loading, milling speed, milling time, bead diameter/density, and temperature are important formulation and process variables.
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Evaluating your system’s performance and compatibility earlier in development can ensure you have a viable product to support development phases.
INJECTABLE DRUG DELIVERY SOLUTIONS
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We are the exclusive manufacturing partner for this innovative auto-injector platform.
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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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AST aseptic filling products address the unique processing requirements of biologics manufacturing to gently care for biologic products during the fill-finish process. Their highly accurate peristaltic dosing system uses single-use pharmaceutical grade tubing that has been optimized to keep shear stress to an absolute minimum. When exiting the fluid path through the filling needle, the motion control system maintains the fill needle within the container and slowly rises as the product is being dispensed to minimize splashing and foaming that could introduce stress to the product. Temperature controlled filling is also possible with the ASEPTiCell® and GENiSYS® systems. AST has experience dosing products at temperatures as low as 3°C.
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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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Unlock superior performance for peptides and proteins using nanotechnology. Achieve high drug loads for subcutaneous delivery and stable, aerodynamic dry powders for deep-lung inhalation.
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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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West presents Crystal Zenith vials in a nested packaging configuration, designed to meet the exterior dimensions of glass standard ISO 8362-1.
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Integrated formulation, analytical, and bioanalytical capabilities plus advanced facilities tackle complex chemistry, delivering accurate data, regulatory confidence, and smooth study progression.
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Innovative technologies in the pharmaceutical industry are enabling a patient-centric approach in medicine. Auto-injectors provide an easy, convenient drug-delivery system for patient self-administration — improving compliance and dosage accuracy.
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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.