Wednesday, April 12, 2023 Daily Archives

mRNA Process and Cost Modeling: A Tool to Optimize Process Development

The COVID-19 pandemic brought into focus the impact that mRNA technology can have on rapid drug development. mRNA is an attractive modality to work with because of its relative simplicity compared to other biologics; it is wholly synthetic and does not require cellular materials. Demand for mRNA-based medicine production in lower income countries continues to increase, as do investments in prophylactic and therapeutic indications such as infectious diseases and cancer. We developed a cost-model to compare all modalities such as…

Spain’s mAbxience adding another 4kL single-use bioreactor

mAbxience is installing another ABEC 4,000 L single-use bioreactor at its facility in León, Spain. Biologics contract development and manufacturing organization (CDMO) and biosimilar supplier mAbxience installed an ABEC 4,000 L single-use bioreactor (SUB) system in 2021 to “significantly increase” capacity at the facility in León, located around 250km northwest of Madrid. Now the firm, a joint Venture between Fresenius Kabi and Insudpharma,  is doing it again, with another 4,000 L bioreactor set to be installed at the plant, which…

Overcoming Lipid Nanoparticle Delivery Challenges with Low-Volume Subvisible Particle Measurements

When it comes to successful drug treatment, the key lies not only in the active drug but also in the technology used to deliver it. Ensuring drugs reach their target effectively is paramount, yet this is often easier said than done. Fortunately, advances such as lipid nanoparticle technology (LNPs) provide a promising solution that can deliver large payloads, exhibit low immunogenicity, and enable manufacturing scalability. But there are still hurdles to overcome. Like all biologics, LNPs can be physically unstable1,…

VintaBio bags $64m to ease viral vector bottleneck

The $64 million in funding has supported the opening of VintaBio’s cell and gene therapy (CGT) facility in Philadelphia, US. VintaBio’s $64 million funding round was led by Decheng Capital, and the investment supported the development of the contract development manufacturing organization’s (CDMO’s) 22,500 square-foot Philadelphia plant, which has been designed specifically to streamline CGT development and production. “Over half of the funding has gone toward the facility, which includes not just the infrastructure but also the laboratories” David Radspinner, CEO of…

CDMO round-up: AGC Bio, Lonza, and Exothera deals

ABL Bio has selected Lonza to support its bispecific antibody candidate; AGC Biologics has signed a service agreement with The Jikei University in Japan; Remedium Bio has picked Exothera to support the manufacturing process for its lead candidate. Great to have you here for BioProcess Insider’s CDMO round-up. First up in our contract development manufacturing organization (CDMO) round-up is Swiss company Lonza, which Korean biologics firm ABL Bio recently selected to support the development and production of its bispecific antibody product. Under…

Pierre Fabre in $618m EGFR deal with Scorpion

French pharma-cosmetic company Pierre Fabre has acquired the rights from Scorpion Therapeutics for two epidermal growth factor receptor (EGFR) inhibitors in Europe and China. Pierre Fabre will pay $65 million upfront and up to $553 million in milestones, plus royalties for the two candidates, described by Boston, Massachusetts-based Scorpion as highly selective mutant EGFR inhibitors aimed at treating non-small cell lung cancer (NSCLC). Scorpion will retain commercialization rights to STX-721 and STX-241 in the US, Canada, and Japan, while Pierre…