Manufacturing roundup: GSK opens a new facility at Barnard Castle location; Tenaya Therapeutics completes buildout of Bay Area genetic medicine manufacturing site
GSK is continuing to build out its Barnard Castle site in the UK.
According to the company, it has opened a new aseptic smart manufacturing facility at the site, which is located in County Durham in the northeast of England.
The new facility, known as Q Block, is a fully automated and digital facility that leverages digital technology to make manufacturing operations as efficient as possible.
The 11,500-square-meter facility started construction in 2018 and according to the UK news site Business Live, the costs for the new building were £90 million, or around $110 million.
“The Q Block facility puts GSK and Barnard Castle at the forefront of medicines manufacture and I am delighted the site will play such an important role in supporting the delivery of our innovative pipeline,” said Elizabeth Rowbotham, site director for Barnard Castle.
The facility will look to manufacture existing and new biopharmaceutical assets in GSK’s portfolio, however, the details on what will be produced or how many new jobs this will create have not been revealed to Endpoints News.
Barnard Castle is one of GSK’s largest manufacturing sites in the UK, employing around 1,000 people and supplying nearly half a million packs of products per day to 140 markets. The site itself was founded in 1945.
Sweden’s NorthX Biologics is entering the cell therapy manufacturing game with Alder
Swedish-based NorthX Biologics, a traditional manufacturing service with expertise in plasmids, proteins and other compounds is looking to enter a new and increasingly competitive market.
The company is expanding into cell therapy manufacturing at its existing GMP facility, as well as in premises in Matfors, Sweden at the Karolinska University Hospital campus in Stockholm.
According to the company, this initiative is part of NorthX’s Innovation Hub, a measure designed to provide development and GMP-manufacturing services to the drug development companies and research groups who are working on more advanced therapies.
After founding the biotech BioLamina, Kristian Tryggvason launched his latest venture called Alder Therapeutics. The company has now agreed to help NorthX expand its cell culture services to many new different cell types, including pluripotent stem cells. The Alder team will also help to design and validate NorthX’s new process development and GMP-manufacturing labs in Matfors and Stockholm.
“This expansion into cell therapy is a major step to completing our offering for innovative clients. We are especially excited to work with Dr. Kristian Tryggvason, a leader in cell therapy technologies, and his team,” said Ted Fjällman, CEO of NorthX.
Bay Area Biotech launches new manufacturing center for genetic medicines
Tenaya Therapeutics is forging ahead in the competitive field of gene therapy production.
The company has finished the build-out of its Genetic Medicines Manufacturing Center in Union City, California. Tenaya is looking to advance a pipeline of therapeutic candidates, including several AAV gene therapies, for the potential treatment of both rare and prevalent forms of heart disease.
“The operational launch of Tenaya’s Genetic Medicines Manufacturing Center represents an important milestone as we prepare to advance our robust pipeline of potentially first-in-class cardiovascular therapies into initial clinical studies,” said Tenaya CEO Faraz Ali.
The 94,000-square-foot facility has manufacturing suites and labs, office space and storage and is now fully operational with the initial capacity to produce AAV-based gene therapies at the 1000L scale. The new location is also designed to meet regulatory requirements for the production of AAV gene therapies.
According to the company, their initial production efforts will support first-in-human studies of its lead gene therapy, TN-201.
The candidate is being developed for the treatment of genetic hypertrophic cardiomyopathy (HCM). The company plans to submit an IND to the FDA in the second half of this year. The facility will also support the production of TN-401, its gene therapy program being developed for the treatment of genetic arrhythmogenic right ventricular cardiomyopathy (ARVC), which will go to the FDA in 2023.
The company, after receiving a sizable $106 million Series C in 2021, went public in the middle of last year. However, it has been feeling the bite of the bear market as its stock is down $TNYA 68% since the beginning of the year.