INJECTABLE DRUG DELIVERY ARTICLES
Is Oncology Precision Medicine Coming of Age?
Developers are releasing new data suggesting that their targeted therapy candidates may finally address some of oncology’s toughest challenges.
INJECTABLE DRUG DELIVERY RESOURCES
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A study assessing the stability of vials aimed to determine if the vial material had any influence on the viral titer and particle counts of the AAV serotypes.
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Examine the results of two, two-year studies that indicate good container closure integrity performance that can be achieved with stoppers of a given elastomer, independent of configuration.
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Learn more about the critical tests for ensuring the proper performance of auto-injectors, which are used for a variety of applications ranging from emergency use to treating chronic conditions.
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Examine the dynamic regulatory environment of drug-device combination products as well as concrete steps to take to navigate regulatory complexities and decrease time to market.
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All future submissions are expected to align with FDA's draft guidance that clarifies the agency's expectations for establishing, evaluating, and controlling Essential Drug Delivery Output (EDDO) requirements.
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Review the comparison of two container closure systems which differ by stopper hardness using comprehensive stack-up calculations performed by West’s DeltaCube™ Modeling Platform.
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Understand how formulation development for a prefilled syringe affects manufacturing, driving the industry toward optimizing delivery of injectable products and, ultimately, improving patient care.
INJECTABLE DRUG DELIVERY SOLUTIONS
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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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Developing an optimized formulation tailored to your API nanoparticles is critical to unlocking their full potential.
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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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We are the exclusive manufacturing partner for this innovative auto-injector platform.
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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.
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Integrated device assembly, labeling, and packaging solutions streamline pharma delivery, ensuring compliance, scalability, and patient-centric design from clinical trials to commercial production.
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Sterile fill-finish and device assembly capabilities span global sites, offering scalable solutions, analytical testing, and regulatory compliance for combination products and small-batch technical programs.
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August Bioservices is a US-based, quality-driven CDMO that offers end-to-end drug development, analytical testing, and fill/finish manufacturing services to clients of all sizes and stages, from pre-clinical to commercial.
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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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Subcutaneous
Low - Medium Viscosities
< 100 cP
1 - 10 mlHigh - Ultra-High Viscosities
>100 - 10,000 cP
0.5 - 3 mlArQ® - Bios offers a small, simple to use package to deliver high viscosity formulations. Oval’s proprietary COC PDC technology allows us to build the device around a stronger drug container that can deliver 1ml of formulations up to 1000cP through a 25G needle in less than 5 seconds. The ArQ-Bios platform also can deliver greater volumes than 1 ml subject to matching the formulation characteristics with acceptable patient tolerability.