Gene Therapy Company
Our client is a clinical-stage gene therapy company focused on developing potentially curative treatments for patients living with serious diseases.
They currently have a number of programs in clinical development including four ocular indications, a salivary gland condition, and a Parkinson’s disease program.
Their state-of-the-art UK manufacturing facility was designed to meet global regulatory requirements, including the current good manufacturing practices (cGMP) required by the Medicines and Healthcare products Regulatory Agency (MHRA) in the UK and the U.S. Food and Drug Administration (FDA). And 150,000 square foot GMP manufacturing hub in Europe, provides a flexible, scalable facility increasing capacity for clinical through commercial supply.
Skills & Results
Bulb laboratories have delivered a number of projects for this valued client in the UK.
To support their newly built commercial supply cGMP Manufacturing facility in Europe, they needed quality control (QC) laboratories. Due to our previous experience and exceptional relationship working with the project team, Bulb was invited to deliver the project.
QC suite involved a number of independent labs for various quality control areas such as cell culture, protein and DNA analysis.
Works included creation of these laboratories with installation of a ducted fume cupboard, laboratory benching, storage, and transfer hatches between different labs.
The project presented an excellent opportunity for the Bulb team to work and comply within the international regulations.