Head of Formulation Development for Gene Therapy and Protein Modalities at Takeda
Tanvir Tabish joined Takeda about three years ago and is presently the Head of Formulation Development and Characterisation; Tanvir is currently based in Vienna, Austria. His responsibilities include developing stable formulations for various Gene Therapy and protein based modalities. Prior to joining Takeda, Tanvir worked as an Associate Director, for Beaufour Ipsen, and managed a trans-national Early and Pre-Formulation Development group with members based in Paris and Boston.
The remit of this group was to develop formulations to help with the candidate selection process for small molecules and Biopharmaceuticals. Tanvir has extensive experience of working in the Biopharmaceutical industry having also worked, for 15 years, in the Biopharmaceutical Product Development Division of GlaxoSmithKline. Tanvir has a strong track record of developing formulations for a range of Biopharmaceutical molecules
Title 1: An Intercompany Perspective on Biopharmaceutical Drug Product Robustness Studies
- The outcome of a survey done as part of the Biophorum Development Group (BPDG). The companies which took part included Takeda, Legacy Shire, GSK, BMS, Hoffmann-La Roche, Abbvie, Merck, Regeneron, Biogen, ImmunoGen and Alexion
- Overall DP robustness is defined by both the formulation and the manufacturing process robustness, robustness integrates the principles of quality by design (QbD), DP robustness is an important factor in setting critical quality attribute control strategies and commercial specifications
Title 2: Lyophilisation of AAV Gene Therapy Product
- Biopharmaceuticals show varying levels of stability in aqueous solutions for short periods of time. Lyophilisation is a technique commonly used to improve the stability profile of biomolecules through the removal of water resulting in the increasingly restricted mobility of the reacting species.
- The gene therapy adeno-associated virus (AAV) subtype 8 containing Factor IX was formulated in a new proprietary buffer and lyophilized. A stability study was established with the lyophilized material to determine its stability profile at the accelerated temperature of +5°Cover a 12 month period
- Study demonstrated the feasibility of lyophilisation of the AAV drug product in an appropriate formulation buffer