Extensive AAV and lentiviral vector production capabilities & expertise
Yposkesi is a full-service CDMO, providing professional support through all stages of gene therapy development. We make available the entire viral vector manufacturing services necessary to enable you to rapidly and successfully develop ATMPs. You gain access to specialized expertise with integrated project management as well as streamlined and cost-efficient bioprocess development services:
To help you successfully navigate the administrative process, Yposkesi’s regulatory unit:
- Defines Yposkesi’s regulatory strategy according to its activities, the product manufactured and their stage of development.
- Oversees the regulatory management of the pharmaceutical establishment.
- Provides legislative and regulatory watch to ensure compliance.
- Provides regulatory intelligence and technical support to services and customers.
- Coordinates and consolidates comments on draft and published regulatory texts and guidelines.
- Establishes Yposkesi’s policy on ad-hoc questions.
- Prepares CMC information as needed.
- Supports customers in their response to health authorities for CMC information following IMPD filing.
- Provides support for writing client IMPDs (to be established).