Facilities & Capacity

Amgen Breaks Ground on $160m Rhode Island Plant

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Amgen has broken ground on a single-use and modular biomanufacturing facility at a site in Rhode Island. The groundbreaking ceremony at the West Greenwich site took place today in the presence of the governor of Rhode Island, Gina Raimondo and congressman Jim Langevin. Construction of the plant will begin in September. The facility, first announced in April, will make biologics for the US and global market once operational. It has been described as a “next-generation biomanufacturing plant,†meaning it is…

July 31, 2018

Bioproduction: A ‘Tale of Two Facilities,’ Says Jacobs

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The advent of single-use bioreactors has revolutionized facility design says Jacobs, which has worked in the biomanufacturing sector for almost 30 years. As the biotech industry matured in the 1990s, Jacobs Engineering acquired Triad Technologies and Sigel Group to expand its expertise in designing and constructing biotechnology facilities. The firm has since been involved in many of the most prominent biomanufacturing facilities over the past few decades, working on Schering-Plough’s (now Merck & Co.) facility in Tuas, Singapore; Bristol-Myers Squibb’s…

July 30, 2018

Plant Round-Up: Rubius Buys, WuXi Begins, Samsung Approved

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Alexion sells its troubled plant to Rubius; Samsung BioLogics receives its first US license to make a Mab drug product; WuXi Biologics completes a GMP run at its Shanghai facility. Welcome to Insider’s facility round-up. Earlier this month, BioProcess Insider reported newly public Rubius Therapeutics had pledged to invest US$155 million (€133 million) to purchase, renovate and customize a facility in Smithfield, Rhode Island. At the time, the firm refused to divulge who they bought the facility from, but in…

July 27, 2018

Univercells $19m Booster Shot to Help Disrupt Vaccine Industry

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Traditional vaccine makers have limited incentive to invest in new technologies and processes says Univercells, which hopes to advance its own viral vaccines produced in micro-facilities. Univercells has raised €16 million (US$18.7 million) of funding in a Series B financing round led by Global Health Investment Fund. Some of the capital will be used to increase the impact of its proprietary viral platform through the expansion of its portfolio. “Following the platform proof of concept, with its sIPV development program…

July 20, 2018

‘Dramatic’ Gene Therapy Demand Drives Viral Vector Delays

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Some gene therapy developers are waiting more than a year for viral vectors due to the shortage in third-party services, says European CDMO Yposkesi. French contract development and manufacturing organization (CDMO) Yposkesi claims to have the largest industrial platform for the GMP manufacture of viral vectors for gene therapies in Europe. The firm has four independent production suites and two fill & finish suites, with current capacity of 35 batches per year. And now the manufacturer is set to grow…

July 20, 2018

Newly Public Rubius Investing $155m to Renovate Rhode Island Plant

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Rubius Therapeutics will use some of the US$241 million (€207 million) raised in its initial public offering (IPO) to buy and refurbish a manufacturing facility. The biotech firm begins trading on Nasdaq Global Select Market today (July 18) after raising $241 million from the public offering of 10,483,000 shares of common stock. According to the firm’s Form S-1, filed with the SEC, some of the proceeds will be used to “purchase, renovate and customize the manufacturing facility for which we…

July 18, 2018

Sonnet Selects Oncobiologics to Take I-O Assets into the Clinic

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Sonnet BioTherapeutics has completed the discovery phase for its cytokine-based immunotherapy platform and begun a tech transfer to CDMO Oncobiologics. New Jersey-based biopharma firm Sonnet has announced it is planning to move its preclinical candidates towards the clinic, and has begun CMC development for up to four immuno-oncology candidates with a contract development and manufacturing organization (CDMO). John Cini, co-founder and chief scientific office of Sonnet, told BioProcess Insider the CDMO is fellow New Jersey-based firm Oncobiologics, which will manufacture…

July 18, 2018

Shanghai Filling Line is Latest Investment in China for B-I

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Boehringer-Ingelheim will offer both drug substance and drug product services form its facility in Shanghai, China after adding fill & finish capabilities. German drugmaker Boehringer Ingelheim has added a new filling line at its commercial biomanufacturing facility in Shanghai, bolstering its third-party business, BioXcellence. “At our China facility the F&F [fill & finish] service complements the manufacturing service for drug substance at that site, meaning we can now offer drug substance and drug product out of one facility for our…

July 18, 2018

Difficult Q4 for Avid as it Pushes to Diversify Customers and Fill Capacity

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Avid Bioservices says it has worked aggressively to expand since becoming a pure-play CDMO but needs increased customer diversification and capacity utilization to secure future growth. After selling off its internal monoclonal antibody programs to Oncologie and dropping its Peregrine Pharmaceuticals tag, Avid Bioservices completed its transition to a pure contract development and manufacturing organization (CDMO). Six months on, the firm has reported a 62% year-on-year drop in its fourth quarter revenues to US$6.9 million (€5.9 million) and a fall…

July 17, 2018

French CDMO to Make Kymriah as Part of Novartis CAR-T Strategy

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Novartis has selected France-based CELLforCURE as a CAR-T therapy manufacturing partner fresh from receiving European Medicines Agency (EMA) recommendation for Kymriah (tisagenlecleucel). Kymriah became the first chimeric antigen receptor (CAR) T cell therapy to receive approval in the US last August. Last month, marketing authorization holder Novartis came one step closer to bringing the therapy to Europe after receiving positive opinion from the EMA’s Committee for Medicinal Products for Human Use (CHMP). In the wake of this recommendation, the Swiss…

July 16, 2018