INJECTABLE DRUG DELIVERY ARTICLES
Navigating Combination Products: Device Complexity And Software Integration
Software-enabled combination products demand early cross-functional alignment, regulatory foresight, and collaboration to avoid delays and accelerate patient access.
INJECTABLE DRUG DELIVERY VIDEOS
Explore primary packaging developed following well-established ICH principles for sustainable compliance and vial container closure systems for product development and commercial manufacturing needs.
Explore the challenges related to packaging of cell and gene therapy products and proven solutions to enable speed to market and compatibility, performance of packaging materials.
Explore some of the more challenging aspects surrounding in-use testing for parenteral delivery along with potential strategies to address these issues.
A review of the draft guidance and importance of component selection as it relates to establishing a risk-based approach and the role of the NovaPure product line in component selection.
INJECTABLE DRUG DELIVERY RESOURCES
-
![GettyImages-1325053945-lab-team-collaboration]( "How To Ensure Correct Component Selection When Outsourcing To A CMO")
A CMO-recommended lyophilization stopper was contributing to several operational inefficiencies, including sticking and interlocking of stoppers during filling operations. Requalification work was required to make a change.
-
![Female scientist microscope-GettyImages-1453524892]( "Using FT-IR To Identify Contaminants In Drug Delivery Systems & Combination Products")
Learn how formulation, device, quality, and engineering teams can strengthen contamination-control strategies, improve delivery reliability, and reduce product-quality risk throughout the drug-delivery lifecycle.
-
![West Pharma]( "Key Considerations For Packaging Solutions For Cell And Gene Therapies")
Thinking of packaging and delivery factors early and often will minimize risks to the safety and efficacy of your cell and gene therapy drug product from the bench to the patient.
-
![istock1087218874-lab-drug]( "Lyophilization vs. Liquid Formation: Why Lyo Offers Advantages")
Lyophilization offers some alluring advantages in today’s complex market, but its challenges require innovation and expertise to surmount.
-
![Syringes GettyImages-171324030]( "Key Trends And Developments In Injectable Drug Formulation And Delivery")
As the biopharmaceutical market continues to grow, explore the barriers facing manufacturers and how to best evaluate a drug substance's characteristics and determine the most appropriate delivery device.
-
![West1]( "Evaluation And Identification Of Subvisible Particulate Matter In Injections")
Review the scopes of USP chapters <787> and <788>. Both chapters address injections and have the same regulatory requirements according to their nominal volumes for subvisible PM.
-
![GettyImages-1300035668-nanoparticle-particle]( "How Lipid Nanoparticles Overcome Solubility Challenges")
More than 80% of NCEs are poorly soluble compounds. Overcoming this challenge using lipid nanoparticles is essential to move your drug product through the pipeline and into the market.
INJECTABLE DRUG DELIVERY SOLUTIONS
-
![West-C&G 3 - 2mL_10mL_Vials_Tubs]( "Daikyo Crystal Zenith® Ready-To-Use Nested Vials")
West presents Crystal Zenith vials in a nested packaging configuration, designed to meet the exterior dimensions of glass standard ISO 8362-1.
-
![A-MICRO BI]( "Pharmaceutical Vial Filling Machine With Isolator")
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.
-
![Lipid Nanoparticles GettyImages-1437855772]( "Non-Viral Gene Delivery (NVGD) Using Polymeric-Nano Particles")
Examine a NVGD platform that tackles the primary obstacle hindering gene editing therapies: efficient delivery. Utilizing engineered nanoparticles, the platform overcomes limitations associated with payload size.
-
![ASEPTiCell]( "Isolator Barrier Pharmaceutical Aseptic Filling Systems")
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.
-
![GettyImages-1133603364-lab-equipment-microscope-beaker-test tube]( "Formulations For Poorly Soluble And Low Bioavailability Drugs")
Ascendia specializes in the development of market suitable formulations for poorly water soluble drug substances. Based on the pre-formulation data package and the delivery requirements for the product, we recommend a comprehensive formulation development strategy. We understand that each formulation is unique and must address the specific challenges associated with poor solubility, inadequate bioavailability, and/or unacceptable physical/chemical stability. We also understand the urgency companies have for progressing their pipeline, and our approach maximizes the probability of success by exploring multiple formulation options in parallel if necessary.
-
![GettyImages-1171312168-lab-development-research]( "A CDMO With Oral Solid Dose And Sterile Injectable Expertise")
Societal specializes in modified-release formulations, including those for high potent and DEA controlled substances.
-
![GettyImages-1268574717-food-inspect-ship-package]( "A/L/P Assembly, Label And Packaging")
Integrated device assembly, labeling, and packaging solutions streamline pharma delivery, ensuring compliance, scalability, and patient-centric design from clinical trials to commercial production.
-
![StavanatoGroup-Vertiva On-Body Delivery System]( "Highly Flexible And Customizable On-Body Delivery System Platform")
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.
-
![GettyImages-1435081495-Self-Injector_Auto-Injector]( "Transforming Drug Delivery")
Learn how our team of scientists, engineers, and human-centered designers, as well as our world-class facilities, empower us to confidently guide your product toward a successful market launch.
-
![BD]( "Enabling The Delivery Of Complex Biologics With Ergonomic Solutions")
The BD UltraSafe Plus™ passive needle guard for pre-filled ISO standard glass syringes is designed to support viscous drug delivery with ergonomics and drug visibility.
