Quality Manufacturing and Service
Promega first certified to international standards for quality management systems in 1998, and the Promega Madison, USA facility, maintains ISO 13485 certification for the manufacture of products intended for in vitro diagnostic (IVD) use. Currently, 15 Promega facilities around the world have certified to either the ISO 13485 or the ISO 9001 standard.
Full Manufacturing Capabilities include:
- Flexible manufacturing and dispensing lines
- Manufacturing within environmentally controlled spaces
- Formulation and dispensing to requested volume specifications
- Automated packaging of ambient kits—vision systems to perform 100% inspection of kit components and label content
- Separation of pre- and post-amplification processes
- State-of-the-art bioprocess equipment for consistent, high-quality product
Expanding cGMP Manufacturing
In 2013, Promega will open a new cGMP manufacturing facility, dedicated to serving customers who need molecular biology reagents for IVD assays. This includes components such as sample-preparation systems and reagents, which can be used in molecular diagnostic tests provided by other IVD medical device manufacturers. This state-of-the-art 260,000-square-foot complex will manufacture molecular technology tools on both committed (fixed) production lines and flexible manufacturing areas. The building will also house a customer experience center that includes spaces for training, laboratory demonstrations, conferences, and dining.
Custom solutions are essential to help high-throughput and clinical laboratories answer difficult questions quickly. We offer custom services on products for genomics, proteomics, cellular analysis, and high-throughput screening. Scientists can start with an existing Promega product and change the volume, concentration or formulation, the kit components, or the QA testing to meet a specific application. Or, they can work with a dedicated team of experts to create new reagents, technologies, or custom assays for a specific workflow.