Forced Degradation and Stability

///Forced Degradation and Stability
Forced Degradation and Stability 2018-01-02T21:20:25+00:00

VxP Biologics offers complete stability program management in support of IND, clinical, registration stability and post-marketing programs. We offer a secure, DEA-licensed stability suite that covers all ICH conditions, as well as photostability and custom conditions—with over 35,000 cubic feet of stability storage space.

We provide fully validated monitoring systems, redundant chamber systems and 100% backup power supply ensure an optimally-controlled, compliant cGMP environment for QC testing and sample storage. The scientists work closely with the QA group to ensure rapid turnaround of accurate, quality-reviewed data.

cGMP Stability Chambers:

  • 5 °C
  • 25 °C / 40% RH
  • 25 °C / 60% RH
  • 30 °C / 60% RH
  • 30 °C / 65% RH
  • 40 °C / 75% RH
  • 60 °C / 75% RH

cGMP Storage Refrigerators:

  • 5 °C
  • 2 – 8 °C (Warehouse QA Retain Storage)
  • -20 °C (Revco Ultima)
  • -50 °C (Revco Ultima)
  • -80 °C (Revco)

Other Storage Conditions:

  • Controlled Room Temperature
  • Photostability Chambers
  • Custom-Requested Conditions

Data Handling:

  • Stability Laboratory Information Management Software (SLIM™)

Our state-of-the-art labs are staffed by some of the best trained and most experienced subject matter experts in the field.

Contact us today for a free consultation with our scientific team and discover how VxP can be a valuable resource and partner for your organization.