INJECTABLE DRUG DELIVERY ARTICLES
FDA Modernizes Container Closure Guidance: What Is Changing And Why It Matters
The proposed revision reflects changes in packaging technology, drug delivery systems, quality risk management, and more that have occurred since 1999's guidance.
INJECTABLE DRUG DELIVERY RESOURCES
-
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.
-
Learn about the critical role plunger stoppers play in determining a combination drug product's exposure to extractables and leachables.
-
As you aim to reduce costs and ensure on-time delivery, discover the opportunities for drug formulation and commercial supply that can advance your therapy to the clinic and beyond.
-
Particulate-related recalls account for 37% of US FDA injectable drug actions, and evolving FDA and EU GMP requirements are raising the compliance bar for manufacturers.
-
Review the implications of this study on the storage of sensitive molecules that require deep-cold storage and learn how 2R Fina glass vials are poised to enhance cold storage practices.
-
The transition of intravenous in-clinic chronic disease therapies to large volume subcutaneous injections in alternate settings has created an evolving roster of new formulations and treatment options.
-
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.
INJECTABLE DRUG DELIVERY SOLUTIONS
-
From start to finish, NovaPure components have been designed and manufactured using Quality by Design principles to mitigate risk for the patient.
-
Advanced particle engineering enhances the performance and life-cycle of therapeutics. Superior bioavailability, higher drug load, and improved stability are enabled for small and large molecules.
-
West is a leading global manufacturer in the design and production of technologically advanced, high quality, integrated containment and delivery systems for injectable medicines. We are a trusted partner to the world’s top pharmaceutical and biotechnology companies—working by their side to improve patient health.
-
Rotary filler for clinical and early-stage pharma production specialized for fill finish advanced aseptic manufacturing for pharmaceutical and biologics injectables. Designed to be used in an isolator.
-
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.
-
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.
-
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.
-
Analyze a family of fill/finish solutions that offers a complete, configurable solution for biopharmas and CDMOs looking to maximize drug product recovery.
-
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.