Tag: <span>raw materials qualification</span>

Robust and Scalable GMP Manufacturing of Chondrocyte Cell Therapy for Cartilage Regeneration

Cell therapy has emerged as a promising technology that involves implanting live cells to replace/repair and restore normal function of damaged tissue. Autologous chondrocyte implantation (ACI) has been proven effective for the regeneration of articular cartilage in defective cartilage tissue. The process starts with the collection of healthy tissue from an eligible patient, then isolation and expansion of desired cells in vitro under good manufacturing practice (GMP) conditions, qualification before release of the final cell product, and finally, implantation into the patient. The promise to deliver autologous cell therapies has its own challenges in robust and reproducible manufacturing. To commercialize a cell therapy, it is imperative that a robust and scalable manufacturing process is set up that is consistent, in terms of quality and quantity, in order to deliver the intended therapeutic effect.

We analysed the manufacturing parameters of over 100 cartilage samples that were used to deliver our proprietary, commercialized autologous cell therapy. The paper addresses the most cited challenges in the manufacturing of autologous cell therapies and describes a robust process of in vitro human chondrocyte cell culture. Also included are key factors in manufacturing for attaining a high-quantity and quality product for articular cartilage regeneration.

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Cell & Gene Therapy Manufacturing

autologous cell therapy autologous chondrocyte implantation commercialization human chondrocyte cell culture raw materials qualification scalability

Testing Strategies for Mammalian Cell Banks

Contamination by adventitious agents (bacteria, fungi, mycoplasma, and viruses) represents potential safety risks for biologics produced in mammalian cells. Bacterial and fungal contaminations are usually easy to detect in culture medium due to changes in pH and visual indicators such as color and opacity. Mycoplasma contamination has been detected in 15–35% of cell lines deposited in some cell culture collection. This is because mycoplasma contaminations often cause little changes that can be readily detected by visual inspection. However, bacterial, fungal, and mycoplasma contamination can be more effectively controlled than viral contamination by careful screening of initial parental cell banks, proper environmental monitoring, along with ongoing testing…

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Cell & Tissue Banking

contaminant control mammalian cell culture raw materials qualification safety testing viral clearance viral contamination

Characterization and Release of Raw Materials Used in Upstream Processes for Production of Monoclonal Antibodies by Mammalian Cell Culture

Since the mid-1970’s, when Kohler and Milstein first discovered the process by which myeloma cells and splenocytes could be fused to produce monoclonal antibodies (MAbs), a whole new world of important therapeutic, prophylactic and diagnostic products has opened up, bringing in huge benefits for patients and manufacturers. The total sales of therapeutic MAbs reached more than $13 billion in 2005. Sixteen of the 18 FDA-approved MAbs came to the market after 1997, and over 150 are currently in clinical development, suggesting their increasing medical importance and the remarkable, recent advancements in development technology…

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Biologics Production

characterization growth promotion test mammalian cell culture monoclonal antibody raw materials raw materials qualification