Werum offers a digital supply-chain solution for managing cellular and genetic therapies
Werum IT Solutions, providers of manufacturing execution systems (MES) and related IT, has a strategic partnership with Blood Centers of America (BCA), a network of independent blood centers that represent nearly 40% of the North American blood supply. The partnership will cover both autologous and allogenic CGTs—the former requiring pickup and delivery of the patient’s own cells; the latter requiring closely managed collection of cellular materials. Supply chain management in CGTs is an evolving field; practitioners in the subject speak of a “chain of compliance” from and to patients, almost always involving close temperature control of cells, and frequently requiring cryogenic preservation.
Werum is a well-recognized player in life sciences MES; its flagship solution, PAS-X, allows for creation and management of electronic batch records. Dr. Andreas Fischer, sr. head of Werum’s SafeCell business unit, says that an end-to-end solution covering both manufacturing and logistics will be developed. Charles Mooney, VP Bio-Development & Quality Management at the Oklahoma Blood Institute and BCA Cell Therapy Committee Chair, adds that “To efficiently manage cell and gene therapies the market needs a comprehensive ‘vein-to-vein’ IT solution that we will create together.”
An Exploration of Compounding Practices
May 22nd 2025In a Q&A with Pharma Commerce, Kurt Lunkwitz, ProRx Pharma’s COO, uncovers the stringent requirements that 503B outsourcing facilities must abide by under the Drug Quality and Security Act, while also shedding light on the FDA’s impact when it comes to improving the safety, quality, and trust in compounded drugs.