Introduction:
Merck with an investment of US$31 million (€29 million) has completed the construction of new biologics testing centre in Shanghai, China.
Features:
The testing centre not only provides cGMP-compliant lot release testing for unprocessed and purified bulk harvests but also ensures that these tests meet the stringent requirements for biologics entering preclinical and clinical studies, as well as licenced biologics.
Expanding on the existing lab space established just last year, the centre plans to increase its area by 1,500 square metres. This expansion will occur in two phases:
The initial phase focuses on augmenting testing services specifically tailored for viral clearance studies.
In the second phase, the centre will enhance its capabilities to conduct thorough cell line characterisations. These added capabilities are designed to support biopharmaceutical customers by meticulously assessing and verifying the safety, purity, and identity of their cell banks.
These new biosafety labs provide unprecedented access to diverse testing services for cell line characterisation and lot release, spanning from pre-clinical development to commercialisation.
The facility's phase two completion has expanded its scope to encompass a wide array of biosafety testing services. It now caters to monoclonal antibodies, various recombinant proteins, as well as cell and gene therapies.
Specifications:
Name Merck
Type New Construction
Budget US$31 million (€29 million)
