Thursday, September 14, 2023 Daily Archives

Viral Clearance in the Age of Q5A(R2) and the Case for Using Noninfectious Spiking Agents

As viruses can arise during the manufacture of biopharmaceuticals, regulatory agencies require “viral clearance” validation studies for each biopharmaceutical prior to approval. For example, Type C Retrovirus-Like Particles (RVLP) are endogenously produced during CHO cell expression. As such, regulatory agencies require proof that downstream process steps can effectively remove or inactivate retrovirus. A model mammalian virus, Xenotropic Murine Leukemia Virus (XMuLV) is typically used to demonstrate RVLP clearance. However, the establishment of RVLP quantification methods has made it possible to…

Benefits of a Customized Cell Line Development Program

Cell line development at Just-Evotec Biologics is focused on lowering the cost of manufacturing and creating highly productive cell lines for our clients and partners. To achieve this, we leverage our own in-house GS knockout CHO host cell line, which has been shown to support cell densities up to 80 M cell/mL and productivities upwards of 5 g/L/day in our perfusion bioreactor platform. Additionally, we have implemented advanced instruments and liquid handling automation to increase the throughput of processes that…

Moderna scaling back manufacturing network post-COVID

Moderna says it is addressing the rising cost of goods from underutilized COVID vaccine capacity by downsizing its manufacturing network. Moderna’s rise to the dizzying heights of Big Biopharma status came through its rapid response to the COVID-19 pandemic. It’s vaccine Spikevax – the second messenger RNA (mRNA) product to win approval – brought in $7.7 billion in 2021 and $18.4 billion in 2022. (For context, Moderna’s pre-pandemic revenue in 2019 stood at $60 million). To support sales, the company…