Friday, September 30, 2022 Daily Archives

eBook: Chromatography — Addressing Pain Points To Mitigate Downstream Bottlenecks

Compared with significant advances in upstream production of recombinant proteins, downstream purification processes have undergone far less development over the past twenty or thirty years. Technologies are emerging for continuous-mode and/or multicolumn chromatography (MCC) operations, but commercial-scale biomanufacturing operations still rely on chromatography equipment and processes that closely resemble those used at the advent of monoclonal antibody (MAb) manufacturing. Thus, chromatography operations generally have not kept pace with upstream gains, resulting in manufacturing bottlenecks at purification stages. Compounding that concern…

Boehringer Ingelheim rolls out VR training at fill-finish facilities

Boehringer Ingelheim has deployed Virtuosi, a virtual training (VR) educational platform, across three of its aseptic manufacturing sites. Virtuosi, developed by Quality Executive Partners (QxP), claims to be the “world’s first” and singular multi-language immersive training platform training platform for the pharmaceutical manufacturing operators in aseptic processing, cell and gene therapy processing, and microbiology. The VR training platform will be deployed at Boehringer Ingelheim’s Biberach and Ingelheim sites in Germany, as well as a plant in Lyon, France. According to…

Rocket bolsters AAV pipeline with Renovacor buy

Rocket Pharmaceuticals will gain Renovacor’s program REN-001, an AAV-based gene therapy targeting BAG3-associated dilated cardiomyopathy (DCM) through the acquisition. Under the terms of the deal, Rocket, a firm focused on genetic therapies for rare childhood disorders, has acquired Renovacor, a company aiming to deliver precision therapies for individuals battling genetically-driven cardiovascular and mechanistically-related diseases. Rocket claims that the acquisition strengthens its adeno associated virus (AAV) based cardiac gene therapy leadership and scales the firm’s clinical assets for the treatment of…

Starting Strong with Quality Materials for Immune Cell Therapies

In this article, we take a closer look at key considerations for establishing a reliable supply chain of quality materials to ensure a robust and reproducible workflow for immune cell therapies. As immune cell therapies advance through the development pipeline, the need for an optimal scaling strategy becomes more apparent. Much of the deliberation centers around cell expansion approaches to attain clinically relevant cell numbers and features such as automation and process control to ensure high-quality cell products. Yet there…