Case Study: Complex Medical Device
August 2, 2024
SMC Ltd. helped a large surgical device developer bring a highly complex balloon kyphoplasty device to market quickly, while improving quality.
Read More
Sterile Fill Finishing Services
Intro
Accelerating Your Therapy From Bench To Clinic
We know that when it comes to clinical trials, time is of the essence if you want to gain market advantage.
Our experienced and expert engineers adopt your laboratory-scale formulation as their own, quickly delivering a robust process for clinical trials, phases one to three. Whether your formulation is viscous, a suspension or gel, we will work with standard and custom containers to ensure you benefit from a seamless, expedited process. From formulation, through container closure integrity and fill-finish processing to terminal sterilization, final assembly and even secondary packaging, we remain by your side throughout.
What We Do
Delivering the Flexibility and Speed You Need
Our purpose-built cGMP facilities are designed to deliver a complete fill-finish service for parenteral batches and clinical trials. Renowned for decades for our ability to deliver a fast, flexible and integrated service, we support you through the clinical trial phases, into scale-up and onto commercial capacity.
All filling is 100% isolator-based, conducted within best-in-class, Grade A isolators. Our filling lines are designed to accommodate exceptional flexibility for a of range container types, volumes, and formulations, including standard and custom presentations.
Scaled to Your Needs at Every Stage of the Lifecycle
Our sterile-fill finish facility is designed to meet up-to-date regulatory requirements and includes state-of-the-art HVAC systems and clean rooms. Each suite is equipped with isolators and fill-finish equipment to support batch sizes from 100 units to 15,000 units in vials, cartridges, or syringes, enabling you to benefit from economies of scale, improvements in process and negating the need for tech transfer to another facility.
Faq
Frequently Asked Questions about SMC and Medical Contract Manufacturing
Do you have a global footprint?
Yes, SMC is a global organization with 11 locations – United Kingdom, India, Costa Rica and 9 located in the United States (California, Ohio, Wisconsin (4), Massachusetts, North Carolina).
What are the differences between each manufacturing facility?
All SMC facilities are designed to produce high-volume medical devices, but each location has unique specialties. For example: SMC Somerset specializes in silicone manufacturing. North Carolina serves as our dedicated fill-finish location. Our facilities are strategically located to provide convenient access and support to our customers. To determine which facility is best suited for your project, we recommend reaching out to us for personalized guidance. Contact us for more information.
What percentage of your manufacturing is medical?
All of SMC’s manufacturing falls in either the Medical Device, Diagnostics, or Pharmaceutical Markets. We do not manufacture anything in other markets.
What makes SMC different from other CDMOs?
At SMC, we stand out among other CDMOs (Contract Development and Manufacturing Organizations) because of our unique approach and capabilities. Not only are we a privately held company with an actively engaged management team, but we also specialize exclusively in medical manufacturing, serving the medical device, diagnostic, and pharmaceutical markets.
Our end-to-end manufacturing solutions cover everything from design to production, including fill-finish capabilities. With subject matter experts (SMEs) available every step of the way, we ensure a seamless process tailored to your needs.
What truly sets SMC apart is our proprietary auto-injector technologies, which we offer exclusively to our customers.
When does SMC prefer to get involved with a new project?
At SMC, the sooner we can get involved, the better! However, we’re happy to assist at any stage of your project. Whether you’re starting with a simple concept—like a napkin sketch—or transferring a fully developed program through a lift-and-shift process, we’re here to help.
It’s always best to engage your Contract Manufacturer (CM) as early as possible during your program’s planning phase. Early collaboration allows us to partner with you effectively and thoroughly review the manufacturing aspects of your project for optimal success.
Do you have a purchasing organization that manages the supply chain?
At SMC, the collaborative supply chain teams, led by our Chief Supply Chain Officer, employ best-in-class techniques to ensure customer success on a global scale. The SMC-approved supplier list includes multiple alternatives for all major commodities, providing diverse sourcing options to mitigate risk. We collaborate closely with internal stakeholders, including finance, engineering, operations, and legal teams, to ensure alignment and support for procurement strategies tailored to address customer concerns and needs. By building and nurturing strong relationships with key suppliers and partners, we leverage strategic advantages that foster innovation, enhance pricing power, and provide flexibility in production and transportation.
Key performance indicators (KPIs) are utilized to measure the effectiveness of procurement strategies and operations, driving continuous improvement in supply base processes, systems, and practices. Our approach anticipates and mitigates risks by accounting for economic, geopolitical, and environmental events that may impact procurement and supply chain operations. Additionally, we achieve buying power through a combination of concentrated spending with key suppliers, independent pricing and minimum order quantity (MOQ) negotiations, and the use of purchasing data and forecast extrapolations.
How do you manage risk for your customers?
Our success in managing potential supply risk is rooted in our focused approach across several key areas. We maintain a strong core of senior technical and commercial leaders within SMC, ensuring that experienced leadership drives risk management efforts. Identifying supply risk areas and implementing mitigation strategies is a core responsibility of our senior management and their teams. To stay ahead of our customers’ capacity needs, we pre-invest in infrastructure, ensuring preparedness and adaptability. Consistent technology investments enable us to mitigate risks related to both obsolescence and security.
Additionally, we provide safety stock of both raw materials and finished goods to support our customers’ needs. Where applicable, we employ dual sourcing for critical components to enhance supply chain resilience. Lastly, site-specific business continuity plans allow us to respond quickly and effectively to unexpected events, minimizing potential disruptions.
Are you ISO Certified?
Yes, all SMC Facilities are ISO 13485 Certified and FDA registered. Learn more about our certifications.
Thought Leadership
Explore Case Studies, Articles and Other Resources
Our contract manufacturing capabilities, focused on single-use and disposable medical devices, include innovative autoinjector platforms designed for subcutaneous or intramuscular injection. These platforms can be customized to your drug formulation.
