The Center for Breakthrough Medicines (CBM) has opened their new analytical testing services laboratories to address growing capacity needs in the supply-constrained cell and gene therapy market. More than 2,500 submissions are currently under review in the FDA’s cell and gene therapy pipeline. This volume, combined with FDA’s increased scrutiny, has caused bottlenecks for product release results, with testing queues of up to 8 months. By 2025, the FDA expects to receive upwards of 200 ...