Meet the 2022 FOYA Innovation Category Winner: CRISPR Therapeutics
Winners in this category exemplify the novel application of process manufacturing techniques, innovative design concepts, new technologies and unique solutions that exemplify the next generation of agile, flexible, efficient and effective new and existing pharmaceutical and biotechnology facilities. This includes implementation of commercially available and custom developed equipment which yielded superior results, improved competitive position, and/or demonstrated imaginative collaboration with vendors/suppliers/manufacturers.
CRISPR Therapeutics was co-founded in 2013 by Dr. Emmanuelle Charpentier, who won a Nobel Prize in Chemistry in 2020. The company is focused on developing gene-based therapies for serious human diseases including Sickle Cell Disease, Diabetes and cancer using the CRISPR/Cas9 gene-editing platform.
The facility is unique in utilizing a compact design with multiple independent production suites, each capable of producing a different product at a different stage of development while maintaining strict product segregation. We were particularly impressed with the use of a fully integrated digital stack that enables a small on-site warehouse to be continuously supplied from external sources yet still maintain uninterrupted production and testing operations.
FOYA Judges
In 2021, they opened a GMP manufacturing facility in Framingham, Massachusetts, to focus on the production of CRISPR-based therapeutics. The facility is being used to produce clinical candidates, and is designed with capacity to produce commercial products in the future. It was built purposely to provide an end-to-end solution for production and fill operations and has support space for managing raw materials and waste along with warehouse, quality control (QC), manufacturing, science and technology (MSAT), and office space.
Aspects of the design and implementation that are innovative include the use of separate and redundant air handling capacity that allows for independent operation and shutdown of each of the manufacturing suites, the ability to treat any of the suites with vaporized hydrogen peroxide (VHP) and isolation of personnel flows for operators involved in critical starting material and final drug product manufacturing. This flexibility allows the plant to be configured to produce multiple clinical products (when only a small number of lots per year are needed), a single commercial drug product (when many lots per year of only one product would be needed), or any combination in between.
Because CRISPR Therapeutics can have multiple production suites producing different products at different stages of development, there is an immense amount of data that is collected and the ability to access the right data at the right time is critical to managing production, testing and release of products, calibration and maintenance of equipment, and staff training. To manage this, CRISPR Therapeutics implemented a fully digital control system that monitors and controls shop floor and laboratory equipment, collects and archives process and testing data, feeds batch records, maintenance, and facility status to the operating floor, and integrates personnel training and environmental, health, and safety (EHS) data. The information is available through a secure network and provides traceability to the quality management system (QMS).
The facility and manufacturing systems require minimal time for product changeover and has resulted in reduced cost of goods, labor, and cycle times and limited downtime. In fact, the facility can operate 27/7/365 due to the design of the dedicated utility sets for each clean manufacturing space and the supporting spaces in the facility. This approach provides a consistent and reliable supply chain.
About CRISPR Therapeutics: CRISPR Therapeutics is a leading gene editing company focused on developing transformative gene-based medicines for serious diseases using its proprietary CRISPR/Cas9 platform. CRISPR/Cas9 is a revolutionary gene editing technology that allows for precise, directed changes to genomic DNA. CRISPR Therapeutics has established a portfolio of therapeutic programs across a broad range of disease areas including hemoglobinopathies, oncology, regenerative medicine, and rare diseases. To accelerate and expand its efforts, CRISPR Therapeutics has established strategic collaborations with leading companies including Bayer, Vertex Pharmaceuticals and ViaCyte, Inc. CRISPR Therapeutics AG is headquartered in Zug, Switzerland, with its wholly-owned U.S. subsidiary, CRISPR Therapeutics, Inc., and R&D operations based in Boston, Massachusetts, and business offices in San Francisco, California, and London, United Kingdom.
Nominate Your Facility for the 2023 FOYA Program!
Apply for a chance to join this prestigious list of innovative game-changers and let ISPE honor your organization as a 2023 FOYA program winner. Applications must be submitted by 2 December 2022.
