Global Markets

Celltrion outlines 120,000L China plant and corporate rejig

Celltrion has confirmed it will build a biosimilars plant in China and may merge its healthcare and pharma units. A spokesman told Bioprocess Insider: “Celltrion plans to build a plant in China in a move to directly advance into the world’s second-largest biopharmaceutical market. Celltrion signed a business agreement with the city government of Wuhan and the provincial government of Hubei Province on 20 January 2020. “The company’s business roadmap centers on building a plant with a production capacity of…

Tessa and CellVec both set up Singapore plants to support cell & gene therapies

Tessa Therapeutics will open a plant in Singapore for its CAR-T programs, while CellVec has opened a viral vector facility on the island state to support customers’ gene therapy projects. Singapore-based biotech Tessa is developing its own autologous cellular therapies and has told us it plans to open a 90,000 square-foot plant to support clinical and commercial efforts. “Tessa will use the new facility for the clinical and future commercial manufacturing of our late-stage clinical programs,” the firm said, adding…

UMass Lowell opens pilot freeze-drying development lab

UMass Lowell has opened a lyophilization testing facility where researchers and biopharma can develop freeze-drying processes in a non GMP environment. The facility – dubbed LyoBay – is located in the Mark and Elisia Saab Emerging Technologies and Innovation Center at UMass Lowell, which is located northwest of Boston. It is intended as a development space for scientists and biopharmaceutical companies according to executive director, Karen Hamlin. “The LyoBay offers users the opportunity to take their product technology from the…

China Oks first CDMO-made MAb since Drug Administration law revision

China has approved tislelizumab, a drug for Hodgkin’s lymphoma developed by BeiGene and made locally by Boehringer Ingelheim. The monoclonal antibody (Mab) is the first biopharmaceutical approved under China’s recently modified Drug Administration Law (DAL). The law was revised in August introducing a marketing authorization holder (MAH) system similar to those in the US and EU. The revision also formalized rules governing contract manufacturing. Previously, regulatory approvals were contingent on the developer having its own manufacturing capacity in China. However, in 2015 the…

How process optimization brought Bivigam back to the market

ADMA Biologics says a data driven approach was key to bringing its primary immune deficiency disease drug Bivigam back to market. Bivigam (Immune Globulin Intravenous [Human], 10% Liquid) relaunched in the US in August, roughly three years after it was pulled from pharmacy shelves by then owner, Biotest Pharmaceuticals Corporation. Biotest withdrew Bivigam in late 2016 after a US FDA inspection team uncovered “multiple manufacturing inconsistencies and control issues” at its facility in Boca Raton, Florida. ADMA bought Biotest in…

Korean CDMOs set for Government-backed biopharma boom

South Korean CDMOs are poised for significant growth after the Government said contractors are key to its efforts to encourage drug R&D and manufacturing in the country. In May South Korean President Jae-in Moon announced this summer that the country will invest more than KRW 2 trillion ($1.7B) in the biotechnology and biopharmaceutical industry. Moon said, “We will do our best to create an ecology of innovation tailored to all stages of growth from technological development and approval and licensing…

Biotech VC down 20% in US as policies drive away foreign investors, BIO

Reforms to a US national security regulation are putting off foreign investors and driving down VC investment in the biotech space by as much as 20 percent, says BIO’s David Thomas. In August 2018, Congress passed the Foreign Investment Risk Review Modernization Act (FIRRMA) as part of the Fiscal 2019 National Defense Authorization Act. The Act broadened the scope and oversight of the Committee on Foreign Investment in the United States (CFIUS) to include the review of foreign investments in companies…

Symbiosis ups aseptic capacity by 25%; plans to expand further in 2020

The expansion addresses sustained demand particularly for cell and gene therapy services, says Scottish CDMO Symbiosis. Contract development and manufacturing organization (CDMO) Symbiosis Pharmaceutical Services has completed a £1.5 million ($1.8 million) expansion at its site in Stirling, UK – about 40 miles northwest of Scottish capital Edinburgh. The investment increases the firm’s output by about 25%, CEO Colin MacKay told this publication, and will help feed the demand aseptic GMP manufacturing (fill/finish) services. “Expansion of the business relates specifically…

The 12 trends of Christmas: A look back at 2019

CAR-T partnerships, Biopharma megamergers, biotech funding, and an eye on China. Bioprocess Insider presents the biggest stories of the year… through song! T’was the days before Christmas, And all through the dept. Not a story was breaking and journalists wept. So why not look back at the news of the year, The editor suggested over a beer… In the past twelve months Bioprocess Insider brought to you (To the tune of traditional Christmas song ‘The Twelve Days of Christmas’): A…

Samsung BioLogics brings Berkeley Lights’ Beacon to Korea

Korean CDMO Samsung BioLogics will use the Beacon optofluidic platform to reduce cell line development timelines and boost its drug development services. Having first entered the contract development space in 2017, Samsung BioLogics has now inked a deal to use Berkeley Lights’ Beacon pre-programable and automated optofluidic platform to service its customers cell line and process development projects. The technology itself is based on a nanofluidic chip consisting of chambers in which cells are placed to be cultured and assayed,…