SMC Ltd. provides world-class device contract manufacturing with complete services for the Drug Delivery, Diagnostics, and Medical Device markets. Concept through commercialization services include: design, device development, manufacturing of clinical trials, and commercial scalable manufacturing. Services also include integration of filled primary drug containers with secondary packaging and distribution. Our global facilities are ISO 13485 certified, FDA registered, cGMP and Part 4 compliant.
Oval Medical Technologies, an SMC Ltd. Company, provides robust autoinjector platforms to meet the needs of patients and a broad range of drugs including biologics. Oval’s patented integrated primary drug container technology provides customers with complete service from customization of subcutaneous and intramuscular platforms, to production of clinical trials devices and commercial scale manufacturing.
Meeting The Challenge Of Delivering High Volume Biologic Therapies
Biologics offer more targeted therapies and fewer side effects compared to the small-molecule drugs which came before. As the industry moves towards self-administration to reduce healthcare costs and improve convenience for patients, there is a compelling need for simple-to-use, low-cost disposable devices for domestic use.
High Viscosity Formulations: Developing An Effective Primary Drug Container System
The past few years have seen a significant increase in the number of high viscosity (HV) formulations (100 – 1000 cP) being developed. There are a number of steps that autoinjector developers can take to meet the challenges posed by such formulations. This white paper focuses on some of the techniques used to develop the ArQ™-Bios high viscosity platform.
Choosing A CMO: Find The Best Match By Asking The Right Questions
When selecting a CMO, it’s important to look at organizational alignment, senior leadership engagement, program management, commitment to projects large and small, and processes in place to manage risk.
Insights Into Drug Delivery Device Manufacturing From Development Through Commercialization
Biologics and other targeted therapy techniques are creating opportunities for innovative device solutions that meet the needs of specific patient groups. As these therapies often require low annual volumes, the associated device manufacturing strategy must also fit commercial expectations, even at those volumes.
Keys To Driving Consistent Quality In Contract Manufacturing
Complex products and supply chains present plenty of opportunities for failure, especially when new products are being developed and launched. This article discusses key ingredients to robust and advanced quality planning that are essential to quality in contract manufacturing.
Polymeric PDC Technology: The Value Of Cyclic Olefins Drug Containers In Designing Autoinjectors For Highly Viscous Formulations
The design of autoinjectors for increasingly viscous and high-volume drug requirements presents significant challenges in today’s pharmaceutical market. New materials offer opportunities to overcome these challenges. Oval Medical Technologies has been working extensively with COP to meet these requirements and, additionally, to achieve exceptional performance, flexibility and reliability. This article discusses the value of cyclic olefins drug containers in the design of autoinjectors for highly viscous formulation.
‘Smart Devices’ vs. ‘Smart Design’ In User-Centric Autoinjector Design
Oval Medical has developed a novel Prefilled Primary Drug Container that resolves many drug compatibility and functionality issues associated with the use of traditional glass syringe and rubber plunger technologies.
Improved Autoinjector Design Integrates Cyclic Olefin Syringe
Oval Medical has developed a novel Prefilled Primary Drug Container that resolves many compatibility and functionality issues associated with traditional glass syringe and rubber plunger technologies.
Drug Characterization: A Key Factor In Autoinjector Design For More Challenging Formulations
The most recent innovations in injectable formulations are beginning to push the limits of many traditional drug delivery platforms. Long acting injectables and biologics make up an increasing proportion of the drugs in development, with potential consequences including viscous formulations, complex fluid properties and high injection volumes. This article discusses the process used for the delivery of these formulations through developing an in depth understanding of their properties, and the unique challenges that they pose at the very earliest stage in the design process.
Using Polymeric PDC Technology To Improve Auto-Injector Design
The limitations of using glass-based auto-injectors, such as contamination, and the need for delivering complex, viscous preparations, have led to a new approach that uses polymeric PDC technology instead. This article takes a look at what polymeric PDCs can offer in making auto-injectors truly patient-centric.
Combining Human Needs With High Viscosity Formulations
This white paper discusses the requirements of designing an autoinjector capable of handling the high pressures necessary for the delivery of highly viscous drug formulations with minimal impact on the patient.