Case Study: Genentech achieves FDA approval for Xolair with TransPerfect translation services

Genentech - Customer Case Study

Genentech, working with Novartis to bring the asthma drug Xolair to market, faced the urgent challenge of translating over 1,000 pages of French master batch records into English to meet FDA submission requirements. Because pharmaceutical submissions demand exact terminology, consistent quality and preserved formatting, Genentech engaged TransPerfect’s Life Sciences translation services to handle the regulated, time-sensitive work.

TransPerfect leveraged a substantial translation memory of client‑approved technical terminology and its ISO 9001:2000 three‑step translate/edit/proofread process to convert roughly 150,000 words while maintaining intricate formatting and regulatory accuracy. The project was completed ahead of schedule, enabling FDA approval of Xolair—now used to treat tens of thousands of patients—and strengthening TransPerfect’s relationship with Genentech (and establishing a new relationship with Novartis).

Genentech