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Biologic drug products are not new – their development began decades ago; the first monoclonal antibody was commercialized in 1986. [1] With the increasing availability of genetic information, and better understanding of subcellular cascades and disease processes, the number of biologic drug products available has increased substantially in response to an exponential growth in targets. [2]
Biologic drug products can be composed of sugars, proteins, nucleic acids or combinations thereof – also they may be composed of living entities such as cells and tissues. Frequently, they involve large, complex molecules [3] and are often administered parenterally [4].
A critical concern in formulation development is the relationship between API concentration and drug product viscosity. Large molecules result in high viscosities, but high viscosity drug products cannot be injected easily. As a result, dilution is performed, which may result in large dosage volumes.
Delivery of large volumes is a challenge. A way to address this is with pre-programmable, easy-to-use, wearable injectors – such as the West SmartDose® drug delivery platform – that can deliver larger volumes at a pre-programmed delivery time. West is committed to safe, efficient delivery of drug products to patients.
For more on how West can support your drug product, contact a Technical Customer Support (TCS) representative or visit the Delivery System section of the West Knowledge Center.
SmartDose® is a registered trademark of West Pharma. Services IL, Ltd., a subsidiary of West Pharmaceutical Services, Inc.
West markets SmartDose® as a multi-component system only. Final assembly of the prefilled component is completed by the pharmaceutical company.
Standing front and foremost in biologic drug formulation is the optimization of safety and efficacy while ensuring quality and stability during manufacturing. Biologic manufacturing subjects the formulation to different stresses and conditions that may compromise quality and stability. Recently, the requirement for the development of subcutaneous formulations for high dose drugs, such as monoclonal antibodies, at high protein concentrations has created additional challenges, including degradation.
<p style="margin: 0in 0in 0pt;"><span>West is pleased to announce new extensions of the SmartDose® drug delivery platform, including several new wearable injectors that allow for up to 10 mL of volume to be injected in easy-to-use, wearable formats. The new devices were showcased at the annual PDA Universe of Pre-filled Syringes and Injection Devices conference in Vienna, Austria, in November. </span></p>
West’s SmartDose® platform has been selected as a finalist in the 19th Annual <a href="http://mdeawards.mddionline.com/">Medical Design Excellence Awards</a> (MDEA) competition. Considered the medtech industry’s premier design competition, MDEA recognizes significant achievements in medical product design and engineering and the many people behind the scenes—engineers, scientists, designers and clinicians—who are responsible for the cutting-edge products that are improving patient healthcare.
In a previous <a href="/blog/2012/may/lifecycle-planning"><span style="text-decoration: underline;">post</span></a>, my colleague Fran DeGrazio discussed lifecycle planning and the use of a single material for packaging components from development through commercialization. There has been a great deal of innovation around drug container materials. Although glass has been the traditional material of choice for drug containment, it has significant limitations including breakage, glass particulate, visual quality and functional performance.
Patient safety is defined by the Institute of Medicine as: the prevention of harm to patients.<sup>1</sup> The extension of this principle to general safety in healthcare is: the freedom from accidental injury, and it applies not only to patients, but to all professionals and workers in the healthcare field.<sup>2</sup>
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