Nanotechnology Now

Our NanoNews Digest Sponsors

Heifer International

Wikipedia Affiliate Button


DHgate

Home > Press > BD Medical Pharmaceutical Systems confirms novel cross-linked silicone coating product performance using Nanoparticle Tracking Analysis

Demonstration of NTA from BD Medical: Sub-micron range particles counts of XSi, baked silicone and conventionally lubricated BD syringes (particle counting, 200nm-12m using a NanoSight NTA system1).
Demonstration of NTA from BD Medical: Sub-micron range particles counts of XSi, baked silicone and conventionally lubricated BD syringes (particle counting, 200nm-12m using a NanoSight NTA system1).

Abstract:
NanoSight reports on how Nanoparticle Tracking Analysis, NTA, has been used to demonstrate the product performance of BD Medical - Pharmaceutical Systems' novel cross-linked silicone coating, BD XSi, used in BD's prefillable syringe BD Neopak XSi

BD Medical Pharmaceutical Systems confirms novel cross-linked silicone coating product performance using Nanoparticle Tracking Analysis

Salisbury, UK | Posted on October 27th, 2013

Silicone oil is commonly used as a lubricant coating in prefilled syringes (PFS) and is becoming one of the most highly discussed topics in the PFS market, particularly for developers of highly sensitive biotech drugs. In specific biological drug cases, unexpected drug-container interactions have been reported that were potentially attributed to or potentially associated with sub-visible particles generated from the lubricating silicone layer. These could lead to "solution inspection" concerns or even compatibility concern. Sebastien Jouffray is Core Team leader in the R&D Product Development Group at BD Medical - Pharmaceutical Systems. He leads a team working on an innovative immobilised silicone coating, (XSi). BD XSi significantly reduces sub-visible particles (SbVPs) while retaining lubrication performance. BD XSi does not introduce any new materials, enabling rapid implementation in PFS for both legacy as well as pipeline drugs.

Detection of SbVPs, defined as particles that cannot be reliably detected by visual inspection with unaided human eye, is continuously being improved by emerging analytical techniques. In particular, the extension of the SbVP size detection limit below 10 m, potentially into the sub-micron range, and the ability to differentiate the nature of those particles will greatly enhance the potential to monitor and report this critical attribute. Such analytical techniques can be used to understand better the contribution of silicone lubricant in prefilled syringes, to the overall pool of detected SbVPs. This knowledge will be critical to monitor, control and, if a specific need arises, reduce this contribution.

This need led Jouffray to add new techniques to his arsenal of characterization tools. He used Nanoparticle Tracking Analysis from NanoSight to clearly show that their new coating, BD XSi, radically reduced the presence of particles compared with traditional baked silicone and conventional sprayed-silicone prefilled syringes. This data, reported in a focus on injectable drug delivery by ONdrugDELIVERY1, clearly demonstrated that BD XSi provides a true reduction in particles in both micron and sub-micron ranges and not just a shift in counts from one range to another.

Noting the benefits of using NanoSight's NTA instrumentation in complement to other characterization techniques, Jouffray said "NanoSight allows for the counting of nano-sized particles in small sample volumes in parallel with other techniques. This gives us cost effective routine characterization technique verifying the quality of BD Neopak XSi and for pharmaceutical companies a new technology to count SbVPs in nano range scale" To find out about the company and to learn more about particle characterization using NanoSight's unique nanoparticle tracking analysis solutions, visit www.nanosight.com and register to receive the next issue of NanoTrail, the company's electronic newsletter.

1Improving compatibility with biologics with a novel cross-linked silicone coating - S Jouffray, No. 33, July 2012, www.ondrugdelivery.com, Frederick Furness Publishing.

####

About NanoSight
NanoSight delivers the world's most versatile and proven multi-parameter nanoparticle analysis in a single instrument.

NanoSight's "Nanoparticle Tracking Analysis" (NTA) detects and visualizes populations of nanoparticles in liquids down to 10 nm, dependent on material, and measures the size of each particle from direct observations of diffusion. Additionally, NanoSight measures concentration and a fluorescence mode differentiates suitably-labelled particles within complex background suspensions. Zeta potential measurements are similarly particle-specific. It is this particle-by-particle methodology that takes NTA beyond traditional light scattering and other ensemble techniques in providing high-resolution particle size distributions and validates data with information-rich video files of the particles moving under Brownian motion.

This simultaneous multiparameter characterization matches the demands of complex biological systems, hence its wide application in development of drug delivery systems, of viral vaccines, and in nanotoxicology. This real-time data gives insight into the kinetics of protein aggregation and other time-dependent phenomena in a qualitative and quantitative manner. NanoSight has a growing role in biodiagnostics, being proven in detection and speciation of nanovesicles (exosomes) and microvesicles.

NanoSight has installed more than 600 systems worldwide with users including BASF, GlaxoSmithKline, Merck, Novartis, Pfizer, Proctor and Gamble, Roche and Unilever together with the most eminent universities and research institutes. NanoSight's technology is validated by 900+ third party papers citing NanoSight results. NanoSight's leadership position in nanoparticle characterization is consolidated further with publication of an ASTM International standard, ASTM E2834, which describes the NTA methodology for detection and analysis of nanoparticles.

For more information, please click here

Contacts:
NanoSight Limited
Minton Park
London Road
Amesbury SP4 7RT UK
T +44(0)1980 676060
F +44(0)1980 624703
www.nanosight.com


Talking Science Limited
39 de Bohun Court
Saffron Walden
Essex CB10 2BA UK
T +44(0)1799 521881
M +44(0)7843 012997
www.talking-science.com

Copyright © NanoSight

If you have a comment, please Contact us.

Issuers of news releases, not 7th Wave, Inc. or Nanotechnology Now, are solely responsible for the accuracy of the content.

Bookmark:
Delicious Digg Newsvine Google Yahoo Reddit Magnoliacom Furl Facebook

Related News Press

News and information

Superconductivity: Footballs with no resistance - Indications of light-induced lossless electricity transmission in fullerenes contribute to the search for superconducting materials for practical applications February 9th, 2016

SUNY Poly and GLOBALFOUNDRIES Announce New $500M R&D Program in Albany To Accelerate Next Generation Chip Technology: Arrival of Second Cutting Edge EUV Lithography Tool Launches New Patterning Center That Will Generate Over 100 New High Tech Jobs at SUNY Poly February 9th, 2016

Making sense of metallic glass February 9th, 2016

Electron's 1-D metallic surface state observed: A step for the prediction of electronic properties of extremely-fine metal nanowires in next-generation semiconductors February 9th, 2016

Nanomedicine

Nanoparticle therapy that uses LDL and fish oil kills liver cancer cells February 9th, 2016

Leading bugs to the death chamber: A kinder face of cholesterol February 8th, 2016

UTHealth research looks at nanotechnology to help prevent preterm birth February 7th, 2016

Scientists take key step toward custom-made nanoscale chemical factories: Berkeley Lab researchers part of team that creates new function in tiny protein shell structures February 6th, 2016

Discoveries

Making sense of metallic glass February 9th, 2016

Electron's 1-D metallic surface state observed: A step for the prediction of electronic properties of extremely-fine metal nanowires in next-generation semiconductors February 9th, 2016

Nanoparticle therapy that uses LDL and fish oil kills liver cancer cells February 9th, 2016

Leading bugs to the death chamber: A kinder face of cholesterol February 8th, 2016

Announcements

Superconductivity: Footballs with no resistance - Indications of light-induced lossless electricity transmission in fullerenes contribute to the search for superconducting materials for practical applications February 9th, 2016

SUNY Poly and GLOBALFOUNDRIES Announce New $500M R&D Program in Albany To Accelerate Next Generation Chip Technology: Arrival of Second Cutting Edge EUV Lithography Tool Launches New Patterning Center That Will Generate Over 100 New High Tech Jobs at SUNY Poly February 9th, 2016

Making sense of metallic glass February 9th, 2016

Electron's 1-D metallic surface state observed: A step for the prediction of electronic properties of extremely-fine metal nanowires in next-generation semiconductors February 9th, 2016

Interviews/Book Reviews/Essays/Reports/Podcasts/Journals/White papers

Superconductivity: Footballs with no resistance - Indications of light-induced lossless electricity transmission in fullerenes contribute to the search for superconducting materials for practical applications February 9th, 2016

Making sense of metallic glass February 9th, 2016

Electron's 1-D metallic surface state observed: A step for the prediction of electronic properties of extremely-fine metal nanowires in next-generation semiconductors February 9th, 2016

Nanoparticle therapy that uses LDL and fish oil kills liver cancer cells February 9th, 2016

Tools

Making sense of metallic glass February 9th, 2016

Chiral magnetic effect generates quantum current: Separating left- and right-handed particles in a semi-metallic material produces anomalously high conductivity February 8th, 2016

Metal oxide sandwiches: New option to manipulate properties of interfaces February 8th, 2016

Researchers discover new phase of boron nitride and a new way to create pure c-BN February 5th, 2016

NanoNews-Digest
The latest news from around the world, FREE




  Premium Products
NanoNews-Custom
Only the news you want to read!
 Learn More
NanoTech-Transfer
University Technology Transfer & Patents
 Learn More
NanoStrategies
Full-service, expert consulting
 Learn More











ASP
Nanotechnology Now Featured Books




NNN

The Hunger Project







Car Brands
Buy website traffic