Wednesday, July 17, 2019 Daily Archives

The Cocoon Platform: A Kaleidoscope Approach to Cell Therapy Manufacturing

Matthew Hewitt, the head of clinical development at Lonza’s Walkersville headquarters, unveiled the company’s Cocoon platform at the BPI Theater @ BIO on Tuesday, 4 June 2019. Scalable, fully closed, single-use–capable, and intuitively interfaced, the platform offers what Hewitt terms a kaleidoscope approach to cell therapy manufacturing because it enables drug developers increased ability to customize their processes. The technology also addresses many pain points specific to the cost of cleanroom space, labor, and scalability. These exciting features, Hewitt concludes,…

Cell Line Development Strategies for Difficult-to-Express Proteins

Steven Hager, a senior director of technical support, joined the BPI Theater at BIO on 5 June 2019 to describe how Catalent Biologics’s emerging cell-line engineering technologies can aid in developing therapies based on difficult-to-express proteins. Hager presented two case studies to this end, the first involving insertion of a tag into an antibody for conjugation with a toxin to create an antibody–drug conjugate (ADC), and the second showing another antibody with two sites for conjugation on each chain. Using…

Qualification of Single-Use Sensors for Batch and Continuous Processes

In this 5 June 2019 presentation at the BPI Theater at BIO, Jim Furey contended that the term Industry 4.0 is actually about developing robust sensor systems. A general manager at PendoTECH, Furey recounted experiences with biomanufacturers who chronically reported single-use sensor failures due to intense processing requirements. Even if a process does not involve harsh solvents, Furey points out, several preparation steps can pose problems for single-use sensor systems. Using these experiences, Furey makes the case for more carefully…

A Road Map to Licensure of MAb Manufacturing: Implementing Multicolumn Capture Chromatography

Lilon Huang, a principal engineer of manufacturing operations, delivered a BPI Theater presentation at the BIO International Convention on Wednesday, 5 June 2019, to detail Emergent BioSolution’s efforts to enter the continuous processing arena, specifically the use of multicolumn chromatography. While the move to this technology was designed to reduce costs, Huang explains, it has also created opportunities to partner with industrial leaders in ways that afford crucial feedback for drug design and development. Fill out the form below to…

Multiple myeloma MAb helps drive Q2 as J&J looks to subcu formulation

J&J has reported a 57% year-on-year growth for its multiple myeloma monoclonal antibody Darzalex (daratumumab) and is now hoping to increase adoption through a subcutaneous formulation. For its second quarter 2019, Johnson & Johnson clocked in sales of $10.5 billion (€9.4 billion) in its pharmaceutical division, up 4.4% on the same period last year. The firm attributed this to several of its biological products, not least Darzalex (daratumumab) which grew 57% year-on-year to pull in $774 million in global sales.…