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
-
An aseptic filling and closing machine solution allowed Catalent to reliably process a wide range of both trayed and nested vials for their client product needs.
-
Explore how patients and health care providers perceive and consider using patient-administered medicines to manage chronic conditions, specifically self-administered injectables and on-body delivery systems.
-
What are the sources of such particulates in injectables, and how should manufacturers apply the latest regulations to ensure best practice when producing sterile drug products?
-
The transition of intravenous in-clinic chronic disease therapies to large volume subcutaneous injections in alternate settings has created an evolving roster of new formulations and treatment options.
-
Discover how patient-centric design principles can improve the development of medical devices. By focusing on user needs and behaviors, manufacturers can ensure that products align with expectations.
-
Explore the major considerations for an ideal primary container for viral vector-based gene therapy drug products and the existing and new solutions in this space.
-
The development of drug delivery devices that are innovative, intuitive, patient friendly, and patient safe must address certain areas of concern that are particular to both biologic and biosimilar therapies.
INJECTABLE DRUG DELIVERY SOLUTIONS
-
Discover how Pfizer CentreOne can meet the unique needs of your sterile injectable, powered by Pfizer’s global network of experts, reliability, and flexibility.
-
Our system is ideally suited for the production of pre-clinical, clinical and niche commercial injectable products in vial, syringe, and cartridge formats.
-
Accelerate sterile injectable development with expert support, advanced facilities, and tailored solutions for complex APIs — from formulation through commercialization across small molecules and biologics.
-
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.
-
Unlock superior performance for peptides and proteins using nanotechnology. Achieve high drug loads for subcutaneous delivery and stable, aerodynamic dry powders for deep-lung inhalation.
-
We offer a comprehensive range of automatic inspection machines for injectable pharmaceutical products contained in ampoules, vials, cartridges, syringes and bottles. Designed and manufactured to meet the most demanding technical requirements, our solutions feature different production speeds and advanced vision standards for an optimum performance.
-
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.
-
Intramuscular
0.5 - 3 mlArQ® - Vita can achieve large volume, deep intramuscular delivery, making it the ideal platform to deliver medication for chronic conditions. Built around Oval’s polymeric primary drug container technology, we can create a device that is small and simple to use, whilst housing the correct length needle to achieve consistent intramuscular delivery for your patient population.
-
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.
-
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.