Various cell therapy firms have sold their inhouse facilities, but is this a trend in industry or just coincidence? While manufacturing outsourcing is a staple part of the biopharma world, over the past few years many advanced therapy developers – including Pfizer, Astellas, Allogene and Regenxbio – have lauded the decision to invest inhouse. Many have cited inhouse capabilities as necessary to keep full manufacturing control over complex processes, while others cite the lack of third-party capacity and long booking…

Clene Nanomedicine has quadrupled production capacity to support candidate CNM-Au8, a gold nanocrystal suspension it says could be a gamechanger in the neurodegenerative disease space. The Utah-based biotech has entered into both a 10 year lease for a manufacturing space located in Elkton, Maryland and a seven year lease to further expand its existing manufacturing capacity nearby. The expanded capabilities will serve to support lead candidate CNM-Au8, currently in Phase II studies for amyotrophic lateral sclerosis (ALS). “In our existing…

Japan has put 1.6 million doses of the Moderna vaccine on hold after “foreign materials” were discovered in approximately 565,000 vials. The contamination stemmed from batches of Moderna’s COVID-19 vaccine produced by contract development manufacturing organization (CDMO) Rovi – also known as Laboratorios Farmacéuticos Rovi. The firms conducted an investigation after particulate matter was identified in vials of the vaccine distributed in Japan last week. “According to the root cause analysis report, conducted by Rovi, the most probable cause of…

Samsung has pledged a staggering $205 billion across its businesses through 2023, but how much of this will actually go to its biopharma businesses? This week, Samsung announced plans to invest 240 trillion won ($205 billion) across its businesses over the next three years with approximately $154 billion of this being injected in its home country of South Korea. The plans drawn up include an astounding 40,000 new hires. But while Samsung’s many business interests include life sciences and healthcare…

Lonza says the investment will establish drug product manufacturing capabilities at its facility in Guangzhou, China. Swiss contract development manufacturing organization (CDMO) will install an aseptic fill-finish manufacturing line at its 17,000 square-foot mammalian facility, which began operations in Q2 2021. “With this drug product manufacturing line completed, Lonza represents a complete solution provider to the China market with a special focus on pre-clinical and clinical projects,” said Jeff Li, VP of Commercial Development, Lonza. “This drug product line and…

Demand for lipid nanoparticles for mRNA vaccines has driven Biotage to open a facility at its site in Cardiff, UK.   The facility, of which financial details have not been disclosed, sees Swedish separations firm Biotage expand its manufacturing capacity of large-scale flash columns by 300 percent, specifically to support companies and contract manufacturers scaling-up lipid production for COVID-19 vaccines.   “[Cardiff] is our largest site with capacity and competence for complicated and advanced column filling operations and [it is] geographically close to major customers,” Tomas Blomquist CEO of Biotage told BioProcess Insider. According to the firm, the shortage of raw materials for messenger RNA (mRNA) vaccine manufacturing…