Polysorbate 80 Interferes in the Extrinsic Fluorescence based Tertiary Structure Determination of a Therapeutic Anti-CD20 Antibody with ANS Dye

Order of Publishing in Issue: 
4
Volume :12
Issue :1
January, 2018 - March, 2018
Page No: 
38-42
Authors: 
Balareddy Bheemareddy[1,2], Pradeep Iyer[1], Vijaya. R. Dirisala*[2]
Address: 
[1]R&D Division, Hetero Biopharma Limited, Jadcherla, Mahaboob Nagar, Telangana, India – 509301
Address: 
[2]Department of Biotechnology, Vignan’s Foundation for Science Technology and Research (Deemed to be University) Guntur, Andhra Pradesh, India-522213
Email-ID: 
drdirisala@gmail.com

Therapeutic proteins such as monoclonal antibodies are complex molecules, need extensive characterization before their release into the market for clinical use. Therapeutic protein formulations are routinely characterized for their tertiary structure. Extrinsic fluorescence spectroscopy using various molecular rotors such as polarity sensitive ANS dyes is commonly used for the tertiary structure determination. However, the formulation excipient profile containing surfactants such polysorbate is known to have profound influence in terms of background noise in the extrinsic fluorescence when ANS dyes are used. However, there is neither any study that has clearly indicated the interference of polysorbate 80 in the extrinsic fluorescence profile of a formulated IgG1 monoclonal antibody drug product nor any study has reported the solution to the problem of avoiding interference from polysorbate 80 during extrinsic fluorescence analysis of a formulated monoclonal antibody drug product. Here in this study we reported the interference of polysorbate 80 in the extrinsic fluorescence profile of therapeutic protein drug product and recommending a polysorbate 80 removal step prior to extrinsic fluorescence analysis of drug product for the tertiary structure determination.

Keywords: 
Polysorbate, Extrinsic fluorescence, anti-CD20 antibody, Tertiary structure, ANS dye
AttachmentSize
PDF350.01 KB

 
To download full text articles and issues in PDF at no cost.All you have to do is fill out a brief registration form. It's easy and it's free. At any time, you may request removal of your contact information from our database.
Click here to Register | Click here if you have already registered

2017 ABAP Awards

Invitation for Nominations to 2017 ABAP Awards
The Association of Biotechnology and Pharmacy invites nominations for the following awards from the eligible talented people with proven track record and achievements on or before September 10, 2017 in the prescribed format.

DOWNLOAD CIRCULAR | APPLICATION FORM

AWARDS

Upcoming 0 events

  • No upcoming events available

User login

Counter

  • Site Counter: 0
  • Unique Visitor: 0
  • Registered Users: 0
  • Blocked Users: 0
  • Your IP: 54.226.33.117
  • Since:
  • Visitors:
    • Today:
    • This week:
    • This month:
    • This year: