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A new draft guidance document from ICH, issued jointly with the EMA, adopts the position that the assessment of leachables and extractables requires a holistic framework for risk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 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A review of the draft guidance and importance of component selection as it relates to establishing a risk-based approach and the role of the NovaPure product line in component selection.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
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![BO 1 - GCApp_clemex (both machines with person)]( "Is It Ever Too Soon To Start Your Performance Testing Assessment?")
Developing a safe and effective injectable combination product involves performing risk assessments, establishing a set of Critical Quality Attributes (CQAs), and performing design verification testing.
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![GettyImages-1346675513 lab materials]( "Cut Through Complexity, Gain Speed, And Get Your Drug To Patients ASAP")
Discover top challenges that emerging biologics face, packaging containment offerings and services that help mitigate risks, and ways to reduce obstacles that slow development.
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![Vaccine Vial GettyImages-1216812369]( "Addressing Glass Particulates In Injectable Drug Formulations")
Learn how a new vial design that is capable of reducing the propensity for glass particulate generation on filling lines is enabling a significant, positive impact on product quality and safety.
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![GettyImages-1214112149-lab-team-collaboration-research]( "New Technologies To Improve Solubility Of Brick Dust Compounds")
David Lyon, Ph.D., and Molly Adam answer attendee questions from a recent webinar about three enabling technologies designed to improve drug solubility in organic solvents for spray drying.
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![GettyImages-1462345800-robotics-vial-manufacturing]( "Robotics And AI In Pharma: Driving The Next Wave Of Innovation")
Adopting AI and robotics enhance sterility and regulatory compliance and enable real-time decision-making and reduce human-borne contamination, ensuring the safe production of complex therapies.
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![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.
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![West Pharma - Article 4 - ALS EandL Tile and banner]( "Plan For Your Extractables And Leachables Studies To Meet Submission Timelines")
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.
INJECTABLE DRUG DELIVERY SOLUTIONS
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![analytical-timelines-GettyImages-2247278213]( "A Comprehensive Approach That's Exceptional By Design")
An overview of analytical capabilities to boost product quality, meet regulatory expectations, and drive development through phase‑appropriate methods and specialized testing for complex drug programs.
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![Aseptic Filling GettyImages-1087219366]( "Drug Product Fill Finish And Formulation Solutions")
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.
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![Automated Sys Of Tacome Product]( "Pharmaceutical Aseptic Filling Equipment")
AST’s ASEPTiCell® and GENiSYS® systems combine industry-proven technologies such as robotics and isolator-barrier systems to provide flexible pharmaceutical aseptic filling and closing of ready-to-use vials, syringes, and cartridges with a single machine. These innovative platforms use a modular design approach to provide a truly adaptive system with the capabilities and features necessary for cGMP production of clinical and commercial sterile injectable products.
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![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.
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![Ampoule Aseptic Filling GettyImages-1490244818]( "Pre-Filled Precision In Every Dose")
More than a service provider, we act as an extension of your team, accelerating your drug’s journey from late-stage clinical development to commercial supply.
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![iStock-640282108-fill-equipment-finish]( "cGMP Aseptic Manufacturing And Sterile Fill-Finish")
Experienced CDMOs will implement a cGMP aseptic manufacturing and sterile fill-finish policy to improve drug bioavailability. Aseptic fill-finish is a process in which the drug product, container, and container closure are sterilized separately and then integrated. Combining the drug, container, and closure in a clean room using special equipment that is self-contained in a sterile environment meets FDA guidelines related to cGMP.
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![GettyImages-1964958878 glucose monitor wearables patient doctor]( "Putting More Within Reach")
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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![VFM]( "Pharmaceutical Vial Filling Equipment: VFM")
VFM automatic filling and stoppering machines are designed for injectable solutions in vials.
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![GettyImages-1187680243-biological-indicator-sterilization]( "Sterile Drug Product")
Accelerate sterile injectable development with expert support, advanced facilities, and tailored solutions for complex APIs — from formulation through commercialization across small molecules and biologics.
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![BD]( "Easy-To-Use 1 mL Disposable Autoinjector")
BD Physioject™ 1 mL Disposable Autoinjector is an easy-to-use autoinjector designed to deliver fixed dose injections subcutaneously.
