Antibody drug conjugates and cell line technologies the focus of BPDG19
The 19th Development Group face-to-face meeting discussed antibody drug conjugates (ADC) development resulting in a valuable outputs and key learnings for the member companies. The group examined many aspects of ADC development including: workflow timings and acceleration, analytical models, designation of regulatory starting material and scale up models. It was discussed how companies define their starting materials for ADC’s and how this has huge implications on change management down the line, including the impact it has in terms of informing the authorities about the changes being made.
Pfizer’s Leo Letendre presented a case study on their regulatory experiences with the submission of Two Calicheamicin containing ADC. AbbVie’s Taro Fujimori presented a case study on late stage acceleration of an ADC in Oncology, illustrated by the AbbVie poster.
The second day comprised of case studies to illustrate the current approaches to Cell Line Technologies. A poster session by Amie Lundquist, Shire, incorporated some aspects of the monoclonality point share. This included an examination of the statistical modeling around the imager which lead into Kyle Zingaro’s, Alexion, case study on the qualification of imaging technologies to assure monoclonality, the team’s current thinking on this and a plans for future publication. Duncan McVey, Lianchun Fan and Gabi Tremmi from BMS presented three case studies on their cell line technologies and approaches to clonality that provoked much discussion.
The meeting was held in over 28-29 March, 2017 in Philadelphia, PA, USA and was attended by 44 delegates from 18 member companies.