Process and Assay Development
HAL staff are competent in a variety of primary patient sample processing techniques and are qualified to help you develop the optimal protocol for enriching, culturing, and assessing your preclinical cell therapy product. Let us help you test and validate an end-to-end solution for your sourcing, manufacturing, and CQA needs.
Our infrastructure provides the resources for developing IND-enabling processes and assays to help optimize your preclinical product and bring it to market faster.
BioSample* Sourcing
An internally sponsored observational clinical trial (BioCytics 0001) allows Carolina BioOncology Institute clinical staff to collect healthy donor and patient material for downstream laboratory Research Use Only (RUO). HAL processing specialists employ both manual and automated controlled-rate freezing processes to ensure the proper preservation of biospecimens. In addition to extensive cryostorage space, specialists can also thaw both microtubes and bagged specimens using a best-in-class controlled-rate thawing device.
*All biospecimens are obtained with patient informed consent under Institutional Review Board (IRB) approval and are currently for Research Use Only (RUO).
Translational Analytical Services
The HAL team has years of immunology and cancer research experience in academic, translational, and clinical settings. Our robust and reproducible analyses are designed to expedite the discovery and IND-enabling phases to accelerate your research and development. We employ state-of-the-art techniques and devices to assess identity, purity, safety, and potency of your preclinical effector cells. We maintain expertise in flow cytometry, immunofluorescence, live cell imaging, cytotoxicity assays, and clinical laboratory testing.
cGMP Manufacturing
HAL’s facilities, specialist staff, and diverse selection of user-configurable platforms are designed to address the needs of early Phase I Cell and Gene Therapy (CAGT) sponsors. Our point of care model enables the potential for apheresis for sample collection, cell processing, and patient infusion* all under one roof. Let our team accelerate the development of your preclinical CAGT 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.
*Patient infusion of cell therapy products not currently performed.
Clinical Lab Analysis
The capabilities of the Human Applications Lab are complemented by an in-house high-complexity clinical diagnostic laboratory. The clincal lab participates in the Commission on Office Laboratory Accreditation’s (COLA) program and maintains Clinical Laboratory Improvement Amendments (CLIA) certification through Centers of Medicare and Medicaid Services (CMS). The laboratory is enrolled in the American Proficiency Institute’s (API) proficiency testing program as part of its quality management system. The laboratory performs on site STAT and routine patient testing in three general disciplines.
