Services

The ACT Facility prepares clinical grade cellular therapy products that are classified as more-than-minimally manipulated and must be manufactured under current Good Manufacturing/Tissue Practices (GMP/GTP). The facility provides the required infrastructure, including documentation and systems, to prepare, test and release the cellular products in compliance with federal and state regulatory requirements. The ACT Facility has core staff who are highly experienced in the manufacture of a wide variety of cellular therapy products.

Cellular products (minimally and more-than-minimally manipulated, e.g., cultured and/or genetically modified) are governed by the U.S. Food and Drug Administration and are expected to be manufactured under GMP/GTP as outlined in 21 CFR 211 and 1271. The ACT Facility provides the GMP environment to manufacture such products.

In addition to its ISO 7 environmental rating, the facility provides the required infrastructure (staff training, documentation, monitoring, quality program, etc.) to meet requirements. Manufacturing follows formal standard operating procedures. Each activity is documented using worksheets and batch records, which record all equipment, reagents and disposables used, together with information on calibration dates, lot numbers, expiration dates and manufacturers.

Enabling materials, such as novel retroviral vectors, required for studies are also produced within the ACT Facility following cGMP requirements. Close collaborative efforts between investigators and the ACT Facility allow rapid translation of novel developments from the pre-clinical to clinical trial applications.

Operation under GMP requires a robust and thorough system of documentation to provide evidence of compliance with regulations. At the ACT Facility, this is under the supervision of Quality Assurance (QA) personnel working in close collaboration with manufacturing staff and quality control staff. The staff also coordinates testing by external contract laboratories.

The product is released for clinical use by means of a Certificate of Analysis, which details the results of required testing. Released products are issued for use under written physician orders.

Records of all infusions, adverse reactions and subsequent tests are maintained with the product batch record. In addition, all records pertaining to environmental monitoring, facility and equipment cleaning, staff training, and deviations are maintained by QA as part of GMP documentation.