INJECTABLE DRUG DELIVERY ARTICLES
Complaints Into Practical Action: Human Factors Drug Delivery
Post-market HF are more than a quality metric, they help teams diagnose issues, guide fixes, and improve real-world usability of drug-device products beyond validation.
INJECTABLE DRUG DELIVERY RESOURCES
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This article highlights the importance of scalability and flexibility in the choice of an early-stage manufacturing strategy and how that decision impacts financial outcomes for a drug development program.
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CZ vial-stopper-seal combinations offer a viable solution for the challenges associated with low-temperature storage of cell therapy drug products.
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Gain expert insights into how to develop a spray dried powder formulation and scale it from early feasibility studies to commercial manufacturing.
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Simplify the complexity of combination product development by partnering for integrated support across device design, industrialization, manufacturing, and final product assembly.
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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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Discover how regulatory bodies are adopting a risk-based approach to address the unique challenges of genetic nanomedicines, and stakeholder engagement is essential.
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See a quick visual summary of findings from an early feasibility clinical study featuring a 2-5 mL wearable injector with a viscous placebo.
INJECTABLE DRUG DELIVERY SOLUTIONS
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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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From start to finish, NovaPure components have been designed and manufactured using Quality by Design principles to mitigate risk for the patient.
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Accelerate your path to market with integrated support to streamline processes, reduce delays, and deliver safe, user-friendly drug-delivery solutions.
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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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Our experts support clients with pre-formulation, formulation, process and analytical development, as well as production and registration. We’ve worked on a range of both oral solid dosage and injectable projects for clients over the years.
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A next‑generation injectable system uses shorter, thinner needles to reduce injection risk, lower force and time requirements, and improve comfort and usability for administering viscous formulations.
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Our formulation development and material sciences experts have over 30 years’ experience in pre-formulation and solid state characterization.
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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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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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Ascendia’s team of scientists have decades of combined experience in sterile supplies for clinical trials, making them expert at solving the most difficult formulation challenges. In short, we consistently make the insoluble soluble.