As cell and gene therapies approach commercialization, the industry is looking for scalable manufacturing solutions. Equipment providers need to design specifically for the good manufacturing practice (GMP) environment and the unique needs of cell and gene processing. On 3 April 2019, Kevin Lannon of FloDesign Sonics presented an “Ask the Expert†on one company’s solution. LANNON’S PRESENTATION In a typical cell therapy manufacturing process, steps that require washing, concentration, or buffer exchange include centrifugation, filtration, and counterflow filtration. Each has…
Author Archives: Kevin Lannon
Quantitative Risk Assessment of Bioaccumulation Attributable to Extractables and Leachables in Cellular Immunotherapy Biomanufacturing
Precious patient samples, contamination concerns, and limited product purification options have compelled manufacturers of cellular immunotherapies (iTx) such as chimeric antigen receptor T cells (CAR-T) and T-cell receptor (TCR) technologies toward the disposables industry. Such companies are implementing single-use technologies (SUTs) almost exclusively (1). But despite the dominance of disposable bioprocess platforms and their extraordinary growth in the iTx marketplace, researchers have made limited efforts to understand the perennial and critical bioprocessing risks of leachables and extractables. Here we outline…