VCC Medical NV Enlists EMCM for the Aseptic Processing of Cancer Tissue

The European Medical Contract Manufacturing (EMCM) organization announced it will team up with VCC Medical NV for a unique personalized medicine initiative-the aseptic manufacture of a biologic therapeutic from the tissue of a patient’s tumor.

VCC Medical NV’s Reniale is an autologous, adjuvant tumor cell lysate medication for renal cell carcinoma (RCC) made from the residual cancer cells of a patient’s dissected kidney. According to the company, the immunotherapy helps the body ward off future metastases following the removal of cancerous kidney tissue. Post-removal, the cancerous tissue is processed and "treated with certain additives to produce a vaccine that is injected back into the original patient, classifying it as an autograft," explained Werner Schoeman, marketing and communication manager at EMCM. "The vaccine will stimulate the patients immune system to fight against residual cancer cells and is specific to the original patient."

The adjuvant vaccine has proven in clinical trials to help prolong progression-free survival for RCC patients. EMCM has agreed to aseptically process the tumors at its ISO- and GMP-accredited cleanroom facilities. EMCM has experience with orthopedic biomaterials and in the processing of tissue components such as bones, soft tissues, cells, and skin of both human and animal origins.

"The biggest risk associated with the manufacturing of Reniale, or any other aseptically processed tissue, is contamination," said Schoeman. For the production of Reniale, EMCM periodically performs mock media fills, in which the company simulates the production process using a substitute instead of the actual cancerous tissue. By conducting mock fills, the company can validate that its production process "adheres to the highest sterility standards" and allows it to "identify any potential contamination risks before they occur," added Schoeman.

“Choosing the right partner is of the utmost importance in the sensitive field of personalized medicine manufacturing," said Dirk Rueggeberg, delegate of the supervisory board of Vaccentis AG, the parent company and sole owner of VCC Medical NV. "We are happy to have contracted EMCM, a well-established and reliable partner capable of meeting our specialized needs."

Source: EMCM