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Pharma CMC Documents

Selecta Biosciences - Translation of a large volume (over 1 million words) of CMC documents.

Situation

Selecta Biosciences is a clinical stage biopharmaceutical company advancing a pipeline of differentiated products designed to modulate the immune system. Having entered into an exclusive license with a Chinese firm for a biologic drug, they urgently required the translation and proofreading of multiple large volume documents, including scanned files, from Chinese into English, to be used to form the basis of a US Investigational New Drug (IND) application.

Challenge

Given the deadline for their IND application, Selecta client required one million words and thousands of pages of Chemistry, Manufacturing & Controls (CMC) product development and regulations to be translated within a short turnaround time by a specialist life sciences language service provider.

In the highly specialised field of drug development, it was important to achieve consistency and accuracy of terminology across all documents within the tight deadline. Furthermore, hundreds of pages were scanned tables and non-editable text which needed to be reproduced as per the original layout.

The Results

GlobaLexicon put together a dedicated team, led by an Associate Director experienced in managing large Asian-language projects, to ensure the smooth running and successful delivery of the project. A detailed schedule of staggered deliveries was communicated to the client in line with their priority list of documents.

The team included two project managers and a group of handpicked linguists specially trained in pharmaceutical translation and based in four different time zones in order to meet the tight deadline. As per our ISO-certified processes, a senior editor was tasked with ensuring accuracy, consistency and fluency across all files while our internal QA team checked for completeness of all documents before our weekly delivery. Upon receipt of the staggered deliveries, our internal QA team was not only responsible for checking that all stages of our translation workflow had been completed in accordance with our Quality Assurance procedures but also to merge all sections previously split between linguists back together with the help of our technical team.

Despite the complexity of the files, which included tables and scanned parts, the GlobaLexicon technical team was able to export translatable sections into Word by leveraging the use of proprietary technology and compatible CAT tools. This was to ensure consistency across the files and an accurate replication of the source layout with minimal manual copying and pasting, thus enabling our team of linguists to focus on producing a high quality English deliverable ready for publication.

Selecta was impressed and satisfied with our timely delivery and a certificate of conformity was issued to help them proceed with their IND application on time.

" GlobaLexicon is a reliable and knowledgeable partner when it comes to translations for the biotech/pharmaceutical industry. They are very responsive, asked the important relevant questions at project set-up and delivered high quality translations very rapidly, all of which led to Selecta filing the IND on our aggressive timeline. They have the linguistic capabilities to add value to our materials and we will certainly use their services again in future. "

Senior Vice President R&DSelecta Biosciences