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A D V E R T I S E M E N T F E A T U R E
A D V E R T I S E R R E TA I N S S O L E R E S P O N S I B I L I T Y F O R C O N T E N T
Cellex Groupwww.cellex.me
Cellex Group: a leading and completeservice provider for the manufacture ofcellular immunotherapy productsWith expertise, capabilities, and capacity in abundance, the Cellex Group is an experienced facilityworldwide for allogeneic bone marrow, peripheral blood stem cell and other cellular blood components,and is now growing to become a complete service provider for cellular immunotherapy products.
CAR-T cells are highly promising immunothera-pies for the targeted treatment of leukemia,lymphomas and multiple myeloma. T cells areisolated from the blood of patients, engineeredto produce chimeric antigen receptors (CARs)on their surface, expanded and re-infused intothe patient, where the CAR-guided T cells homein on and eliminate cancer cells.
“Although it may at first sound relatively simple,the current CAR-T manufacturing process andsupply chain are hugely complex, with each steppotentially taking place in a different country,” saidGerhard Ehninger, CEO of the Cellex Group. Forexample, after harvesting blood from a patient inan Italian hospital, the blood may be transportedto Germany for isolation and extraction of T cells.The isolated cells are then transduced with anappropriate viral vector and expanded into thefinal immunotherapy product—a procedure thatmay be completed either on the Cellex site or,after T cells have been frozen and transportedto a pharmaceutical manufacturing plant, oftenin the USA. Either way, once the immunotherapyproduct has been manufactured, it must be fro-zen again, transported and re-imported into theEuropean Union and then returned to the Italianhospital for administration to the patient (Fig. 1).
“Up to 12 different working groups can beinvolved in the entire immunotherapy processfrom initial harvest to administration of thefinal product, each step time-dependent andsubject to national good manufacturing prac-tice (GMP) and cross-border customs require-ments,” explained Carla Kreissig, CEO of CellexManufacturing Transports and Logistics GmbH(CMT), which specializes in cellular immunother-apy manufacture and supply chain management.“Any delay could jeopardize product integrity andpatient treatment.”
Vast experienceand high-quality facilitiesFortunately, the Cellex Group has all steps covered,with long-established capability and expertise foreach stage of the process. Cellex has 20 years’experience in stem cell and bone marrow harvest-ing, and is the most experienced facility worldwidefor allogeneic bone marrow, peripheral blood stemcell and other cellular blood components. Moreover,CMT has established more than 15,000 square feetof dedicated clean rooms, extensive experience incell selection and genetic modification, automatedproduction, cryopreservation and cryo-storageknowhow, as well as processes for specialist trans-portation that operate worldwide.
CMT is also able to draw on its CellCommunity ofhealthy unrelated donors to set up and demonstrateconsistent product production while also providingbiopharma companies and academic institutionswith pharmaceutical-grade cells for research pur-poses and clinical studies. Furthermore, CellMo(Cellex Molpe IT Solutions GmbH) has developedproprietary IT solutions to efficiently manage theentire manufacturing process from start to finish;the integrated software tool enables the mapping ofthe multistage GMP-compliant manufacturing pro-cess, line of scheduling, exchange of all relevant dataand documents, and import/export management.
All-round partner for cellular productsCMT has deep process development, quality,manufacturing and logistics expertise and pro-vides its services to several international leadingbiotech companies and research organizations,while CellMo provides software tools, tailoringthem to customer needs.
“The Cellex portfolio is able to offer uniqueservices to any biopharma or research organiza-tion involved in complex cellular products,” saidEhninger. “Whether it’s planning and coordinatingstem cell donations and clinical trials, cell selection,transduction and expansion followed by cyropreser-vation, cell logistics and worldwide transport ofdelicate cell and blood products, the developmentof new therapies to combat cancer, or managementsoftware, Cellex has the expertise, capabilities,experience and capacity to provide tailor-madeinternational supply-chain management solutionsthat will more than meet your specific needs.”
CMOmanufacturing
/QCcryopreservation
Transportof startingmaterial
Transport ofcryopreservedfinal product
Center-basedmanagement
Patientinfusion
Allogeneic/autologousapheresis
Audit/trainingclinical sites
CellexCellCommunity
Fig. 1 | The Cellex Group. From apheresis, transport, cell selection and genetic modification, automatedproduction, cryopreservation and cryo-storage, the Cellex Group is a full service provider for themanufacturing and transport of complex cellular products and provides software tools, tailored tocustomer needs. QC, quality control.
Gerhard Ehninger, CEOCellex GroupKöln, GermanyEmail: [email protected]
CON
TACT“The Cellex portfolio is
able to offer uniqueservices to any biopharma orresearch organization involvedin complex cellular products
Gerhard Ehninger, CEO,Cellex Group
biopharmadealmakers.nature.com | September 2020 | B1
