GMP 시설

VectorBuilder는 선진 디자인과 최첨단 장비를 갖춘 100,000 sq ft 이상의 현대적인 GMP 시설을 운영하고 있습니다. 모든 영역이 결합된 당사 시설은 다음과 같습니다.

One of the GMP manufacturing suites with 600 m^2 bioreactor at VectorBuilder.
10 GMP manufacturing suites 

Our suites are designed for manufacturing plasmid, viral vector, and cell line production at various scales. Each suite is equipped with independent airflow. Our suites contain Grade A BSC in Grade B/C environment and are BSL-2 certified.

One of the automated sterile filling systems at VectorBuilder.
Fill/finish suites 

Our automated filling system is installed within a Grade A isolator in a Grade C environment.

One of the quality control labs at VectorBuilder.
QC laboratories 

Our QC area consists of multiple lab suites totaling 9,500 ft2 for a wide range of QC assays.

One of the process and analytical development suites at VectorBuilder.
Process and analytical development suites 

We have multiple GMP suites totaling 8,400 ft2 for PD/pilot runs. BSL-2 certified areas are set up with Grade A BSC in Grade C environment.

Warehouse corner with giant shelf for product storage and monitoring at VectorBuilder.
GMP warehouse 

Our 6500 ft2 of warehouse for product storage and monitoring is in compliance to ICH guidelines.

GMP Compliance

Our facilities are designed to meet GMP regulations of US, EU, Japan, China, and PIC/S. Complying with ICH guidelines, they are suitable for GMP production for Phase I/II/III clinical trial.

Upcoming Expansion

Our Stage 3 GMP facilities (~500,000 ft2), capable of large-scale commercial gene and cell therapy drug manufacturing are under construction and will be operational in early 2024. The Stage 3 facilities are expected to host 30+ GMP production suites.

One of the buildings for VectorBuilder's upcoming expansionAerial view of VectorBuilder's three upcoming buildings with 30+ GMP production suites.

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