INJECTABLE DRUG DELIVERY ARTICLES
FDA Issues Final Guidance For pH Adjuster Waiver Requests For Generic Drugs
The FDA has issued a final guidance, Considerations for Waiver Requests for pH Adjusters in Generic Drug Products Intended for Parenteral, Ophthalmic, or Otic Use.
INJECTABLE DRUG DELIVERY RESOURCES
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Ready-to-Use (RTU) 3mL cartridge-based, single-use Pen Devices are specifically designed to ensure consistency of delivery for high-volume, high-viscosity injectable drug delivery systems.
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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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Ahead of the first biosimilar Humira product set to launch in 365 days, this article provides a comprehensive run-down of where biosimilar sponsors stand and the key issues ahead of market formation.
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Learn more about why focusing on packaging solutions early on can keep development on track, help you meet milestones, and get your product to market faster.
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Long-acting, complex drug delivery products, particularly those based on injectable microparticles, nanoparticles, and implants, are among the most attractive parenteral products.
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Battelle’s HIT SCAN™ platform accelerates gene therapy by rapidly designing, screening, and optimizing nanoparticle drug delivery systems using high-throughput robotics and machine learning.
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Explore a unique model to predict injection force designed to decorrelate factors linked to formulation development and the ones linked to container and delivery device selection.
INJECTABLE DRUG DELIVERY SOLUTIONS
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BD Neopak™ XtraFlow™ Glass Prefillable Syringe solution leverages 8 mm needle length in combination with thin wall cannula to reduce pressure drop and enhance flow.
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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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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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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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Our formulation development and material sciences experts have over 30 years’ experience in pre-formulation and solid state characterization.
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Innovative technologies in the pharmaceutical industry are enabling a patient-centric approach in medicine. Auto-injectors provide an easy, convenient drug-delivery system for patient self-administration — improving compliance and dosage accuracy.
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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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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.
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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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BD Physioject™ 1 mL Disposable Autoinjector is an easy-to-use autoinjector designed to deliver fixed dose injections subcutaneously.