Manufacturing, Biologics

FDA Approves First Cell-Based Gene Therapy for MCL

August 06, 2020

The therapy, indicated for a rare form of B-cell non-Hodgkin’s lymphoma, was developed by Kite, a Gilead company, which will manufacture the therapy at its facility in El Segundo, CA.

The Impact of SARS-CoV-2 on Biomanufacturing Operations

August 02, 2020

This article presents the results of a survey conducted to gain insight on the impact of the COVID-19 pandemic on biomanufacturing operations.

Using Process Modeling to Troubleshoot a Bioprocess

August 02, 2020

Process modeling offers an opportunity to troubleshoot for and anticipate difficult aspects of a bioprocess.

Points to Consider for Continuous Downstream Bioprocessing

August 01, 2020

It is critical to evaluate specific considerations, from design to application, for the benefit of downstream bioprocessing and manufacturing.

Novavax and Fujifilm Diosynth Biotechnologies Begin Manufacturing of COVID-19 Vaccine Candidate

July 23, 2020

Fujifilm Diosynth Biotechnologies’ North Carolina site will be used to manufacture Novavax’ NVX‑CoV2373 vaccine candidate for a Phase III clinical trial.

CureVac Receives Funding, Collaborates with GSK on mRNA and mAbs

July 21, 2020

GSK and CureVac will collaborate on mRNA-based vaccines and mAbs. Separately, the EIB and others provided CureVac with financing for development of its CVnCoV vaccine candidate and expansion of manufacturing.

BARDA, DOD Award $450-Million COVID-19 Manufacturing and Supply Contract to Regeneron

July 08, 2020

BARDA and DOD have awarded a $450-million contract to Regeneron Pharmaceuticals to manufacture and supply an investigational double antibody cocktail in development for treating COVID-19.

COVID-19: Shoring Up the Drug Delivery Infrastructure

July 02, 2020

BioPharm International

Manufacturers and the US government are investing heavily in traditional and non-traditional forms and materials to ensure supplies of containers and delivery devices for COVID-19 treatments and vaccines.

Improving mAb Manufacturing Productivity by Optimizing Buffer and Media Prep Process Flow

July 02, 2020

BioPharm International

Innovative approaches, including ready-to-use materials and in-line dilution, can significantly streamline overall bioprocessing operations.

Overcoming Operational and Regulatory Challenges in Autologous Cell-Therapy Facilities

July 01, 2020

BioPharm International

Manufacturers must address scale-out challenges of autologous cell therapy for commercial manufacturing.