Having internal AAV capabilities gives Tenaya Therapeutics control over its processes, timelines, and costs, but CEO Faraz Ali says it will also likely use third-party manufacturers as pipelines progress. Fresh from a $106 million Series C funding, South San Francisco-based cell and gene therapy firm Tenaya Therapeutics is establishing a dedicated facility for AAV (adeno-associated virus) manufacturing to support its emerging portfolio of gene therapy products. “We have leased a 94,000 square-foot space for our new cGMP facility, and we…
Facilities & Capacity
Albumedix more than doubles albumin production with expanded UK plant
Albumedix has completed expansion of its commercial-scale manufacturing facility and established new labs, doubling its albumin production capacity. After more than three years of design and construction work, Albumedix has completed the expansion of its Nottingham facility and is now able to manufacture out of this site. The expansion enables the firm to more than double its albumin production, which is used for stabilization and to deliver pharmaceuticals. “Part of the expansion included the construction of a four-storey building adjacent…
Abzena selects NC for $200m biologics plant
Abzena has selected Sanford, North Carolina as the site of a biologics manufacturing facility equipped with 12x 2,000 L bioreactors. In January, British contract development manufacturing organization (CDMO) Abzena announced the addition of a sixth global site in the US. The exact location of the plant was not divulged. However, the firm revealed this week that the site will be in Sanford, North Carolina. The Sanford facility will cost over $200 million and will be dedicated to manufacturing mammalian biologics.…
Roche secures space at Novartis plant as COVID drives Actemra demand
In the latest example of pandemic-related collaboration, Novartis is prepping to make the drug substance for Roche’s Actemra (tocilizumab), currently being investigated as a treatment for severe COVID-19-associated pneumonia. Novartis has signed an initial agreement with fellow Swiss pharma giant Roche to reserve capacity and implement a tech transfer for the drug substance production of Actemra (known as RoActemra in Europe) from its site in Tuas, Singapore. Actemra, a monoclonal antibody first approved in the US for rheumatoid arthritis (RA)…
CRISPR lauds easy scale-out of autologous sickle cell therapy
The autologous nature of its gene-edited stem cell candidate CTX001 means scaling manufacturing from clinical to commercial will be relatively easy, says CRISPR Therapeutics. Codeveloped with Vertex Pharmaceuticals, CRISPR Therapeutics’ CTX001 is an autologous CRISPR/Cas9 gene-edited hematopoietic stem cell therapy targeting patients suffering from β-thalassemia and sickle cell disease. Production of the candidate involves collecting a patient’s own blood stem cells via mobilization and apheresis and editing them with CRISPR/Cas9 to increase fetal hemoglobin (HbF) expression. When the edited cells…
Catalent completes Wisconsin expansion and doubles its capacity
CDMO Catalent has completed an $85 million expansion at its Madison drug substance facility and has started work on customer programs. The contract development manufacturing organization (CDMO) Catalent has added two mammalian cell culture suites at its Madison facility, meaning the site has five suites in total and has more than doubled its overall capacity. The two additional suites each boast a 2 x 2,000 L single-use bioreactor system that can process batches of 2,000 L or 4,000 L for…
Lonza to make Junshi Biosciences antibody at China facility
Lonza has expanded its collaboration with Junshi Biosciences to develop and manufacture an antibody candidate at its recently opened, Guangzhou facility. Swiss contract development manufacturing organization (CDMO) Lonza has extended its partnership with Chinese firm Junshi Biosciences to advance and manufacture biologics. The agreement also includes the production of an antibody candidate that will be manufactured at Lonza’s site in Guangzhou, China. Under the agreement, Lonza will provide support to develop and manufacture current and future antibody-based products in Junshi…
Resilience adds CDMO Ology to growing manufacturing footprint
Five months after launching, Resilience has acquired Ology Bioservices bagging a facility in Florida. The 200,000 square feet of biomanufacturing space joins a growing footprint, which includes a plant in Fremont, California subleased from Orchard Therapeutics. Financial details regarding the acquisition have not been disclosed, but Ryan Flinn, a spokesman from Resilience told us the addition of contract development and manufacturing organization (CDMO) Ology brings more than 200,000 square feet of mostly biologic drug substance manufacturing space, along with 300…
Singapore site sets Sanofi’s vaccine spend at beyond $2bn
After investing heavily to develop sites in France and Canada, Sanofi will now spend €400 million to establish a vaccine production center in Singapore. The €400 million ($476 million) investment over five years will see Sanofi develop a modular and flexible vaccine manufacturing site in Singapore to supply the Asian market. The site, once operational (estimated in the first quarter 2026) will be capable of running multiple types of vaccine manufacturing platforms and will be able to produce several different…
Horseshoe crabs: COVID-19 further threat to ‘blue blood’ of industry
The industry relies on horseshoe crab blood for endotoxin testing. These marine arthropods are endangered but the race to manufacture COVID-19 vaccines in large volumes is placing them under further threat. Often referred to as ‘living fossils’, horseshoe crabs have inhabited the Earth for more than 450 million years. For drugmakers, it is the horseshoe crab’s blue blood that has remained a fascination and until recently a necessity . The chemicals in the crab’s blood can react to harmful bacteria…