Particulate Matter Testing for Gene and Cell Therapies

Why Gateway Analytical?

We specialize in particulate matter testings for:

• Opaque Cell Based Products
• Gene Therapy Products
• Small Volume Parenterals 
• Difficult to Inspect Products (DIP)
  
  

Our Experts:

• Perform USP <787>, USP <788> and USP <789> Testing

Gateway Analytical offers both Method 1 (LO) and Method 2 (MM) for these compendial methods.

Method 1: Light Obscuration particle count test utilizes an automated instrument that performs counting and sizing based on the amount of light that is blocked by the particle as it passes a sensor. This is the preferred method for counting and sizing sub-visible particulate in drug products however, this method can lead to false negatives when testing cell based products.

Method 2: Microscopic Particle Counting is utilized when Method 1 is not suitable. The particle sizing is performed using a calibrated light microscope, with a magnification of 100±10 and with the use of a circular ocular graticule.

Our reports provide our clients with data formats that both comply with USP methods and are easy to read and understand. 

We then take it one step further by offering full particulate characterization and source determination of the foreign particulate previously detected.

• We use the latest technology and methods to characterize foreign particulate (even down to 2µm)
• We have the ability to build customer-specific reference databases to fast track sourcing and root cause analysis