Manufacturing of cell suspensions for renal cell carcinoma

EMCM was approached by a company with a request to manufacture single cell suspensions in an aseptic environment. The product is a cell therapy for patients affected with late stage renal carcinoma. EMCM has played a significant role in the testing, feasibility, method development and process validations. As part of the scope of this project EMCM has applied for an extended GMP license, liased with regulatory authorities & will start the reconstruction of one of the aseptic cleanrooms to implement all requirements needed for this opportunity.

Xenograft for dental and orthopaedic applications

EMCM has developed a dental membrane for one of the global leaders in the dental market. The membrane functions as a barrier between soft and hard tissue. The product is derived from an animal source and is processed into a decellularised as well as delipidised sterile product for dental application. EMCM has incorporated a novel approach for cleaning and sterilisation of this membrane which involves supercritical carbon dioxide (scCO2). Currently, the manufacturing process is brought to a higher level by the transfer from a feasibility run to a validated manufacturing process.

Collagen-based tissue engineering projects

Modern tissue engineering approaches will be used to treat children with structural birth disorders, such as spina bifida, urogenital defects, gastroschisis, diaphragmatic hernia and esophageal atresia. The multidisciplinary project strives to take a translational route through in vitro and animal experiments to early clinical trials. This will be done by the use of tailor-made "smart" biomatrices (scaffolds) that are prepared using natural scaffold molecules such as type I collagen. Recently, a platform is created for the development of collagen tissue engineering scaffolds for bladder augmentation (i.e. bladder cancer), treatment of hypospadia and epispadia, and application as urostomy.