Current Good Manufacturing Practices
HAL’s laboratory facilities and diverse selection of platforms offers a range of biomanufacturing capabilities. Our newly built GLP laboratory and ISO-7 cleanroom spaces enable full cGMP processing services. Choose from a suite of closed-system devices for your cGMP cell selection and culture needs, with technical staff trained on device operation. Let our team supply your cGMP cells and fulfil your small-scale production requirements using first-in-class technologies.
Current Good Manufacturing Practices
Let our team accelerate the development of your preclinical C> product by offering:
- Upscaling, technology transfer, and process optimization services
- Primary or secondary CDMO manufacturing and processing site
- Requalification/bridge manufacturing runs
- Batch release-clinical laboratory diagnostic correlation
FDA guidance recommends that during Phase I studies, cGMP cell processing assess whether the manufacturing process is optimal to ensure overall product quality. Based on the review, appropriate modifications and corrective actions can be taken to control procedures and manufacturing operations. Our site and staff are well-positioned to assess this need.
- CliniMACS Plus and Prodigy instruments for automated cell selection and culture
- G-Rex for T cell Therapy
- Validated GMP-grade reagents (basal media, serum/serum replacements, cytokines and growth factors, etc.)
- ISO-7 cleanroom and multiple laminar flow BSCs
- Cell processing staff trained in manual and automated workflows
