Wednesday, February 5, 2020 Daily Archives

Automated Cell Line Development With Greater Than 99% Monoclonality On the Beacon® Platform

by

For all cell lines used in production for commercial therapeutics, FDA guidelines require assurance of monoclonality. This standard means that typical cell line development (CLD) campaigns often require multiple rounds of cloning easily spanning several weeks to months. However, Berkeley Lights, Inc. (BLI) has developed the ability to save time and money spent on CLD processes via automation. The uniquely powerful Beacon® optofluidic platform performs single-cell cloning, growth and titer measurements, and recovery of top clones with unrivaled (>99%) monoclonality…

February 5, 2020

Iovance internal network aims to tweak TIL manufacturing process

by

Having its own facility will help Iovance intensify manufacturing of its tumor infiltrating lymphocyte (TIL) cell therapies and help to reduce the 22-day process, the firm says. In May last year, Iovance Biotherapeutics announced plans to construct a 136,000 square-foot facility in Philadelphia, Pennsylvania for the clinical and commercial production of its autologous TIL products, including its lead candidate lifileucel in Phase II trials for metastatic melanoma. Speaking last month at the Phacilitate conference in Miami, Florida, Michelle Simpson-Abelson, principle…

February 5, 2020

Akron says biopharma needs GMP framework for ancillary materials

by

Akron Biotechnology says biopharma needs a common GMP framework for ancillary materials used in the production of advanced therapies Ancillary materials (AMs) are components and reagents used during cell therapy production. They are not supposed to be present in the finished products, but often are which can impact quality and safety. Despite this, at present there are no specific regulations governing the composition, compliance, and qualification of AMs. Instead there are several independent GMP frameworks for such materials. These include…

February 5, 2020

Thermo says Chinese Gov policy will drive growth

by

Thermo Fisher Scientific says Chinese Government support for biopharma will help grow its business in the country. The life science services, tools and technology firm saw full-year revenue increase 5% to $25.54 billion in 2019 according to documents filed with the US SEC last week. The contribution from Thermo’s operations in China increased 13% year-on-year. And China was a major topic of discussion for CEO Marc Casper during Thermo’s fourth quarter call. “Government priorities in China are aligned with the…

February 5, 2020