Supporting a LabVantage Implementation for a Gene Therapy Company
Clarkston Consulting recently completed a Labvantage implementation for a gene therapy company. Read a synopsis of the project below or download the full case study.
Download the Labvantage Implementation for Gene Therapy Company Case Study Here
As an innovative gene therapy client in the process of moving manufacturing from a contract development and manufacturing organization (CDMO) to in-house production, the client’s legacy LIMS solution was not suited to meet the needs of this fast-growing organization. A more robust commercial LIMS was needed to capture the increasing amounts of data, which spanned across bulk drug substances (BDS) and final products (FP), as well as research and development, including biobanking and development runs.
Following a successful LIMS vendor selection, Clarkston Consulting was engaged to not only build master data and provide technical guidance for the new LIMS, but also to provide project management, training, and business alignment workshops to grow the client’s understanding of the new technology.
Clarkston led workshops to showcase the system’s ability to log product batches using sampling plans with predefined testing and assigned specifications, as well as consumable creation and tracking of inventory by expiration or depletion. The Clarkston team then collaborated with the client to determine the best configuration for test methods and other supporting master data objects. Clarkston executed the building of master data objects, developed and facilitated training for end users and subject matter experts (SMEs,) defined a change management strategy, and worked together with the client to perform validation and verification. Data migration included the successful move of over 1,500 master data objects resulting in a successful go live and hyper-care period.
Clarkston was also able to assess the ability for an ERP interface to manage creation of lots for in-house manufacturing and raw materials, serving as a liaison between the vendor and the client.
