Smithers recently supported a client who was upscaling a biopharmaceutical process. The process utilized Single Use Technology (SUT) and the design of the #SUT needed to be changed to support the increased capacity. The client contacted Smithers, a trusted expert, to conduct the appropriate extractables and leachables (E&L) assessment of a large SUS system to meet #FDA and EU regulatory requirements. This case study provides insights into the client's experience with the Smithers process. Download now: https://lnkd.in/dR3utcMh #medicaldevice #chemistry #extractables #biopharma #prefilledsyringes #transport #pharmaceuticals #eandl #pharmadevices #medical #pharmaceutical #usp #designofexperiment #syringes #pharmaceuticalindustrys #projectmanagement #technology #casestudy #singleusetechnology #leachables #casestudy #biopharmaceutical #
Smithers - Medical Device Testing
Medical Equipment Manufacturing
Akron, Ohio 4,627 followers
Helping medical device & pharma product manufacturers bring innovative, compliant, & highly effective products to market
About us
Our team helps medical device and pharmaceutical product manufacturers bring innovative, compliant and highly effective products to market with world-class expertise and extensive, independent testing capabilities at accredited facilities in the UK and USA. Our experienced medical device and extractables and leachables (E&L) testing teams will provide advice, guidance and recommendations as well as delivering test data to help you demonstrate compliance to regulatory guidance or specifications set out by the FDA, EMA, MHRA, USP, ASTM and ISO. Smithers also supports the pharmaceutical industry and the development of biologics and vaccines from discovery through phase IV, with expertise that includes bioassays and high sensitivity assays. Our scientists have expertise in large molecule bioanalysis assay development, validation, and sample analysis.
- Website
-
http://www.smithers.com/medicaldevice
External link for Smithers - Medical Device Testing
- Industry
- Medical Equipment Manufacturing
- Company size
- 501-1,000 employees
- Headquarters
- Akron, Ohio
- Type
- Privately Held
- Founded
- 2005
- Specialties
- Bioanalytical testing, Biomarker assays, Ligand binding, Immunogenicity, Bioassays, and cell and gene therapies testing
Locations
-
Primary
Get directions
Akron, Ohio, US
-
Get directions
Shawbury, Shropshire SY4 4NR, GB
-
Get directions
11 Firstfield Road
Gaithersburg, MD 20878, US
-
Get directions
115 Silvia Street
Ewing Township, New Jersey 08628, US
Employees at Smithers - Medical Device Testing
-
David Tudbury
Vice President Medical Device Testing Europe at Smithers
-
Kirsten Moffatt
Director of Business Development at Smithers Avanza
-
Rachael Boryk
Results-oriented marketing executive with a proven track record
-
Maria Tudor
Senior Scientist| Pharma and Medical Device Testing Expert| MSc Human Genetics|
Updates
-
The ISO 11040-4:2024 standard marks an evolution in the regulatory landscape for prefilled syringes, reflecting advancements in technology, safety, and quality assurance practices. This latest revision builds upon the foundations laid by the 2015+A1:2020 version, incorporating new technical specifications and enhanced testing methodologies to better meet the demands of the pharmaceutical and medical industries. As prefilled syringes continue to play a crucial role in drug delivery systems, ensuring their reliability and safety is paramount. Learn more about the key changes in our newest whitepaper: https://lnkd.in/ggGAX5jG #medicaldevice #iso11040 #designverificationtesting #dvt #combinationdevices #syringe #chemistry #extractables #biopharma #prefilledsyringes #transport #pharmaceuticals #doe #team #testing #usp661 #eandl #pharmadevices #medical #pharmaceutical #usp #designofexperiment #syringes #medicaldevices #pharmaceuticalindustry #elastomericclosures #meddevices #projectmanagement #fda #technology #respiratory #respiratorydevices
Navigating the Key Updates in ISO 11040-4:2024 for Prefilled Syringes - Smithers
smithers.com
-
Dr. Candice Bellis will be attending Extractables & Leachables Asia on November 19-20. She will be speaking about a CROs experience of designing the most appropriate E&L study. Make sure to stop and say hi if you are in attendance.
📅 Extractables & Leachables Asia | 19-20 November 2024 | Shanghai, China (Hybrid) With just two weeks to go until Extractables & Leachables Asia, we’re thrilled to share insights from Candice Bellis, Senior Project Manager at Smithers. Dr. Bellis will be discussing "A CRO’s experience in designing the most appropriate E&L study – a collaborative approach." Discover her unique perspective on E&L studies in our exclusive interview! 👉 Read the full interview here: https://lnkd.in/gGiGSrG6 👉 Explore the full agenda: https://lnkd.in/gDRKnCYk 👉 Get your tickets now: https://lnkd.in/gdEC23uk #ExtractablesLeachables #EandLAsia #Smithers #Conference #HybridEvent #ExtractablesAndLeachables #ExtractablesAndLeachables #EandLAsia2024 #MedicalDevices #Pharmaceuticals #FDA #Conference #HybridEvent #InnovationInHealthcare #CROs #pharmpackaging #clinical #toxicology #Biocompatibility #characterization #casestudy
-
-
Smithers - Medical Device Testing reposted this
Had a great 2 days with David Tudbury and Helen Lewis in Vienna at the Extractables & Leachables Europe conference. We return home with some extra knowledge and well prepared to support our pharmaceutical clients with their biocompatibility programmes. Smithers - Medical Device Testing Smithers
-
-
Smithers - Medical Device Testing reposted this
Phoenix, we’ve arrived! PDA - Parenteral Drug Association, we've arrived! We’re here all day at booth #927—drop by to talk testing or just share your best recommendation for dinner tonight.
-
-
Smithers - Medical Device Testing reposted this
Looking forward to seeing you all!
-
-
Smithers - Medical Device Testing reposted this
Smithers: Global Medical Device and Pharmaceutical Testing Services. Supporting clients Business Goals through Proactive Listening and providing Effective Solutions
Welcome to Sweden and PDA Biomanufacturing !! Come visit our stand to talk through your project testing needs !!
-
-
Smithers - Medical Device Testing reposted this
Charlotte Utting and I representing Smithers - Medical Device Testing at Medical Technology Ireland. Looking forward to a busy 2 days. Visit us at stand #223.
-
-
Smithers - Medical Device Testing reposted this
It was fantastic to return to Frankfurt the last couple of days and to be able work at our new Smithers - Medical Device Testing site. Our infrastructure is all set, and we're eagerly anticipating the arrival of our shiny, new equipment in the next few weeks. It’ll feel like an early Christmas! 🎅🏻 😁
-
-
Do you have questions about compliance testing for your combination devices and pharmaceutical products? Alison Schweda and Michael Kelly will be visiting PDA - Parenteral Drug Association Universe of Pre-filled Syringes, October 22-23 in Phoenix. Alison & Mike will be available to answer all your questions about chemistry analysis and physical and functional testing for your combination devices and pharmaceutical products. #syringe #syringes #team #meddevices #medical #pharmadevices #technology #combinationdevices #medicaldevices #pharmaceuticalindustry #respiratory #testing #respiratorydevices #fda #prefilledsyringes #eandl #designofexperiment #projectmanagement #elastomericclosures #usp #transport #event #pharmaceutical #doe #biopharma #medicaldevice #pharmaceuticals
-