High-Throughput Dynamic Light Scattering Instrument with 21CFR11 Compliance

by | Bioclinical, Biosimilars, Pharmaceutical

Wyatt Technology, a leader in instrumentation for absolute macromolecular and nanoparticle characterization, announces the release of its 21CFR11-compliant software for its groundbreaking DynaPro® Plate Reader II (PRII). The DynaPro PRII is said to be the only high-throughput, automated dynamic light-scattering instrument capable of measuring the size and stability of biopharmaceuticals and nanoparticles directly in microtiter plates, including the most popular 96-, 384- and 1536-wellplate versions.

Wyatt_DynaPro.pngApplications of the DynaPro II
The DynaPro finds extensive application in the biopharmaceutical industry:

  • to characterize aggregation 
  • in thermal, conformational and colloidal stability of biotherapeutics
  • in assessing the developability of candidate molecules with minimal sample consumption in order to identify promising therapeutics
  • in the subsequent rapid development of stable, safe formulations.

Accompanying Software
The DYNAMICS® software for control, data acquisition and extended analysis of dynamic light-scattering data, is included with each instrument. With the release of the 21CFR11-compliant Security Pack (SP) in DYNAMICS, labs operating under GLP or GMP regulatory requirements may now take advantage of the DynaPro PRII’s automation to measure dozens, hundreds or even thousands of samples per day. 

Additional Instruments for GLP and GMP labs
DYNAMICS SP supports additional advanced instrumentation from Wyatt Technology besides the DynaPro PRII. The DynaPro NanoStar, a traditional cuvette-based dynamic light-scattering detector popular with protein scientists due to its high sensitivity and ultra-low sample requirement, has also seen early adoption into GxP labs, as has Wyatt’s Möbius zeta potential/dynamic light-scattering instrument.

With the release of DYNAMICS SP, any GMP or GLP lab that requires determination of nanoparticle size, protein aggregation, or the zeta potential of a drug delivery or diagnostic nanoparticle is now empowered to reduce hands-on time and increase throughput, thanks to the automation made possible by operating the DynaPro PRII or the Möbius with DYNAMICS SP.

Published  Mar 7, 2017

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