INJECTABLE DRUG DELIVERY ARTICLES
GenAI: The Muscle Behind Strong Regulatory Intelligence For Combination Products
In this article, combination product consultant Doug Mead provides the rationale and offers guidance for using GenAI tools to search regulatory databases. He shows the benefits for biopharma developers of conducting “precedent research” into previous regulatory pathways and results for similar or related drug delivery product submissions.
INJECTABLE DRUG DELIVERY RESOURCES
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Explore guidance on the challenges posed by biologics, including overcoming degradation, establishing a stress test process, and the value of lipid nanoparticles (LNPs) and polymeric nanoparticles (NPs).
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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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The injectable product development landscape is changing, and the pressure to accelerate timelines remains constant. What can you do to overcome all the uncertainty and risk?
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Learn how a partner who is committed to ensuring the safety of medical devices by mitigating the risk of chemical interaction with drugs is crucial for navigating the regulatory pathway to approval.
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Discover how a biopharmaceutical company can de-risk the launch process by choosing a suitable autoinjector technology and partner.
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A compound with poor biopharmaceutical properties or improper formulation design could lead to a delay in the project or even program termination.
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Oligonucleotide therapies offer precise treatments for genetic disorders and chronic diseases. They face unique regulatory challenges but hold great promise, especially when combined with FDA engagement.
INJECTABLE DRUG DELIVERY SOLUTIONS
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By partnering with Battelle, your organization can reduce risks and save on investment costs, leading to more successful and sustainable outcomes.
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Adopting a unified, pre-verified drug delivery system streamlines performance testing and data management, ensuring developers reach critical clinical milestones with greater speed.
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As part of Stevanato Group’s commitment to R&D, our analytical testing facilities focus on investigating physico-chemical properties of primary packaging materials and components and studying the interactions between container closure system and drugs. Stevanato Group relies on a multi-disciplinary team of highly skilled professionals, including, scientists, engineers, pharmaceutical chemists and biotechnologists. Their knowledge and experience covers a range of specialized areas including container closure systems and drug-delivery devices.
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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.
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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.
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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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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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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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BD Physioject™ Disposable Autoinjector offers a proven, user-friendly platform for self-injection, enhancing patient comfort, safety, and adherence across multiple chronic disease treatments globally.
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Why take the risk of selecting individual components that may not work well together? The West Ready Pack™ containment system, with proven container closure integrity, provides risk mitigation, convenience, and small quantities.