Facilities & Capacity Archives - Page 43 of 73 - BioProcess InternationalBioProcess International

COVID-19 an opportunity for outsourcing sector, say leading CDMOs

COVID-19 has increased demand for outsourcing but it is too early to tell what long term impact the pandemic will have, say leading CDMOs. Lonza has received more than 40 inquiries about COVID-19 related projects, says CEO Albert Baehny. He told analysts the pandemic “has already offered some new and important opportunities, which are currently under review.” He added, “Inevitably we cannot engage and collaborate in all of those projects. Instead, we are focusing our efforts on selected key development…

MilliporeSigma invests $110m in gene therapy CDMO biz

by Dan Stanton

MilliporeSigma is building a second facility at its gene therapy site in California, adding 11 production suites and more than doubling its viral vector capacity. The life sciences services division of Merck KGaA, MilliporeSigma, has been involved in the gene therapy area since 1997 through its site in Carlsbad, California. In 2016, the company expanded the site from 44,000 square feet to 65,000 square feet to meet growing demand for viral and gene therapy products. Now the firm has announced…

Refocused Seneca says cell therapy plant will support licensing plan

by Gareth Macdonald

Seneca Biopharma has completed a stem cell-based therapy manufacturing facility to support clinical trials in Suzhou, China. The initial focus is Seneca’s candidate stem cell therapy, NSI-566, which is in a Phase II trial at the BaYi Brain Hospital in Beijing for chronic ischemic stroke. Thomas Hazel, Seneca’s senior vice president of R&D told us “The facility is designed to support clinical trial needs including our ongoing trial which will provide data this year in chronic ischemic stroke, not commercialization. “We…

Over-capacity concern drives Bellicum to sell Texas CAR-T plant for $15m

by Dan Stanton

The University of Texas MD Anderson Cancer Center has acquired the 60,000 square-foot Houston facility and entered into an agreement to manufacture cellular therapies for Bellicum Pharmaceuticals. The $15 million (€13.8 million) sale, first announced in January, went through this week and sees MD Anderson Cancer Center take over operations at the Houston, Texas site less than a year after Bellicum completed the buildout of the manufacturing space. The sale took place following an evaluation of Bellicum’s manufacturing strategy as…

J&J’s COVID-19 vaccine: ‘Four production plants, one billion doses by end of 2021’

by Dan Stanton

J&J says its Janssen Adeno vector and PER.C6 technologies provide the ability to rapidly develop and upscale production of its COVID-19 vaccine candidate Not unexpectedly, much of Johnson & Johnson’s Q1 2020 financial call was taken up with talk of coronavirus. “COVID-19 is one of the most severe global health challenges we have seen in our lifetimes, but at the same time, we have unprecedented science and technology available today to help us mount a false and effective response,” said…

Vir and GSK add CDMO Samsung Bio to COVID-19 MAb program in $362m deal

by Dan Stanton

Speed and mass production capacity are key when manufacturing potential COVID-19 treatments, says Samsung Biologics as it becomes the latest CDMO to support Vir’s SARS-CoV-2 monoclonal antibody programs. Vir Biotechnology has a technology that identifies antibodies in people who are protected from, or who have recovered, from infectious disease. The firm is using this platform to tackle the novel coronavirus, and has partnered with GlaxoSmithKline (GSK) to bring lead candidates VIR-7831 and VIR-7832 through the clinic. The company says both…

Inovio’s COVID-19 vaccine enters clinic buoyed by VGXI manufacturing success

by Dan Stanton

Inovio Pharmaceuticals has asked VGXI to scale-up manufacturing of a potential DNA vaccine against COVID-19 after an initial production run provided materials for a Phase I trial that began this week. The first dosing of INO-4800, a DNA vaccine candidate designed to prevent COVID-19, took place this week after the US Food and Drug Administration (FDA) accepted the company’s Investigational New Drug (IND) application. The Phase I study of INO-4800 will enroll up to 40 healthy adult volunteers at the…

In-house advanced therapy production paves way for smaller facilities, expert

by Gareth Macdonald

Cell and gene facilities will get smaller according to an expert, who says automation and the vogue for in-house manufacturing will drive the change. Traditional biopharmaceutical manufacturing has relied on processes or platforms that can be used to make a range of products. For example, CHO-based expression systems are used to make many of the best-selling therapeutic proteins. While the specific processes differ for each product, the technologies and methods are common. The platform approach has influenced facility design. Most…

Akron buys Cambryn plant on back of high CGT demand

by Dan Stanton

The addition of a biomanufacturing plant in Florida will support the high demand for Akron Biotech’s cytokine and media products from the blossoming cell and gene therapy sector. Akron Biotech has expanded its operations by acquiring a biologics facility in Sarasota, Florida second manufacturing plant. The firm makes cGMP-compliant cytokines that are embedded in numerous clinical and commercial cell therapies and the addition of a second facility is needed to expand capacity to meet the tremendous demand, according to Akron…

J&J to expand vaccine capacity as part of $1bn BARDA coronavirus collaboration

by Dan Stanton

Johnson & Johnson (J&J) says it will leverage and expand facilities in The Netherlands and Pennsylvania in efforts to reach one billion doses of a potential COVID-19 vaccine. In February, J&J teamed up with the Biomedical Advanced Research and Development Authority (BARDA), part of the US Department of Health and Human Services (HHS) to develop a vaccine against the novel coronavirus (COVID-19). At the time the company said it would work to upscale production and manufacturing capacities, leveraging its AdVac and PER.C6…