The past few years have taught people around the world that “It can’t happen here” is never a good bet. From the COVID-19 pandemic to political upheavals to Russia’s invasion of Ukraine, we’re all experiencing a reality that would have seemed impossible not so long ago. And as numerous analysts and experts discuss on television and social media and in other publications what such events could mean politically and socially, we at BPI must maintain our focus on the biopharmaceutical…
Pharma 4.0 technologies, offshoots from the Industry 4.0 model, focus on introducing new technologies for increased levels of digitalization within the pharmaceutical manufacturing industry. Many companies hesitate to embrace the Pharma 4.0 concept fully even though digitalization efforts are leading the way toward new levels of efficiency and productivity. The biopharmaceutical industry currently lags behind other industries in implementing digital technologies because of its rigorous and strict regulatory requirements. Adopting Pharma 4.0 tools and concepts benefits manufacturers by harmonizing the…
Charles River Laboratories will manufacture plasmid DNA-based starting materials to support Ziphius Vaccines’ self-amplifying mRNA candidates. The deal will see Belgium-based vaccine developer Ziphius Vaccines leverage Charles River Laboratories’ plasmid DNA network toward clinical testing and further validation of its self-amplifying RNA (saRNA) vaccine candidates. While the specific candidates have not been disclosed, Ziphius’s lead program focuses on COVID-19, though the firm is also looking at developing vaccines against dengue fever, chlamydia, and cystic fibrosis. No financials have been disclosed.…
Small molecule biotech Galapagos has jumped into the cell therapy space through the acquisitions of Cellpoint and AboundBio for €125 ($130) million and $14 million, respectively. The deals move Galapagos into the advanced therapy space, through the addition of Cellpoint’s chimeric antigen receptor (CAR) T-cell therapy pipeline and decentralized manufacturing technology. Dutch biotech CellPoint’s point-of-care supply model, which leverages with Lonza’s closed, automated Cocoon platform, claims to offer 7-day delivery of CAR-T therapies while avoiding logistical complexities associated with the…
As BioPhorum authors stated in 2019, “It should come as no surprise to anyone familiar with biomanufacturing that current designs of bioprocess facilities as well as associated manufacturing spaces and support operations require excessive amounts of manual labor and manual interventions that lead to high labor costs and, consequently, total cost to supply” (1). Back then, a realization was starting to take hold in the biopharmaceutical industry that modern robotics showed great potential. However, a cohesive vision of their future…
Enzyme-linked immunosorbent assays (ELISA) are routinely used to quantitate molecules and despite their popularity, these assays are labor- and time-intensive. Quantitation assays on the Octet® platform can be considered automated forms of ELISA but allow a myriad of benefits compared to standard ELISA assays, notably the ability to detect lower affinity interactions and a reduced hands-on time for the scientist. As with ELISA, the signal reported in quantitation assays is either directly or inversely proportional to the amount of bound…
The modular facility in Union City, California will support the development of cardiovascular gene therapies and lessen Tenaya Therapeutics’ reliance on CDMOs. The firm announced its plans for the Genetic Medicines Manufacturing Center after a $106 million Series C funding round in April 2021. The 94,000 square-foot modular facility will advance a pipeline of adeno-associated virus (AAV) gene therapy candidates for the potential treatment for heart disease, including lead programs TN-201 for genetic hypertrophic cardiomyopathy (gHCM) and TN-401 for arrhythmogenic…
Moderna is bringing local mRNA manufacturing to the UK through a large-scale facility, while BioNTech has broken ground on a modular scalable mRNA plant in Kigali, Rwanda. Is this the start of a localized production trend? BioNTech this morning announced its efforts to bring localized vaccine manufacturing to Africa have reached a milestone with the commencement of construction of a manufacturing facility in Kigali, Rwanda expected to produce around 50 million doses of mRNA vaccine. The news comes eight months…