INJECTABLE DRUG DELIVERY ARTICLES
Conducting A Medical Device Stability Study: A Practical Guide
Stability studies measure how medical devices respond to environmental stresses such as temperature, humidity, light, and time. Let's take a closer look at designing and conducting a stability study.
INJECTABLE DRUG DELIVERY RESOURCES
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Aseptic filling technology is of utmost importance. Explore in great detail an aseptic filling solution that has been specifically designed for laboratory and R&D applications in the pharmaceutical industry.
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Gain expert insights into how to develop a spray dried powder formulation and scale it from early feasibility studies to commercial manufacturing.
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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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The study was designed to investigate CCI over a period of 24 months at ambient, ultra-low and cryogenic temperatures for serum-stopper samples and at ambient temperature for lyo-stopper samples.
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Current component technologies for cartridge-based drug delivery pose challenges. In order to address these challenges, the next generation of cartridge components are evolving.
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Explore how to approach the transition of migrating from a vial to a syringe or cartridge, the necessary compatibility testing, and the stresses on the bulk product during formulation and filling.
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BD’s Vystra™ Disposable Pen for Liraglutide 3.0 mg demonstrated comparable usability to the reference device, helping de-risk ANDA submissions through proactive human factors evaluation.
INJECTABLE DRUG DELIVERY SOLUTIONS
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VFM automatic filling and stoppering machines are designed for injectable solutions in vials.
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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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Ascendia’s team of scientists have decades of combined experience in sterile supplies for clinical trials, making them expert at solving the most difficult formulation challenges.
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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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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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The BD UltraSafe Plus 2.25 mL Passive Needle Guard features an ergonomic design to help support injection comfort and ease of use.
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AST’s ASEPTiCell® is a flexible fill/finish system that can efficiently process medium-sized clinical and commercial batches while meeting all cGMP requirements for cleanliness and sterility.
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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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Learn how a CDMO with robust processes and specialized technologies like automated fill lines can help you speed to market while maintaining consistently high quality of your product.
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Battelle provides end-to-end medical device development services, combining engineering, regulatory, and human-centric design to accelerate innovation from concept through commercialization across diverse therapeutic areas.