Facilities & Capacity

‘Dramatic’ Gene Therapy Demand Drives Viral Vector Delays

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…

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

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…

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

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…

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

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…

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

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…

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

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…

Brexit and Tax Rates Stoking Ireland’s Biopharma Sector

With the UK leaving the European Union and the US cutting its corporate tax rates, the changing business landscape holds both opportunities and challenges for Ireland’s life sciences sector. For decades, Ireland has cemented itself as a major pharma and biopharma manufacturing hub, spurred by low corporate tax rates, and a highly skilled workforce. Its language, proximity to Europe and its membership of the common market have also boosted multinational investment. On the other side of the Irish Sea, the…

Compact Manufacturing: Next-Gen Media Could Save $30k per Run, Amgen

Granulation and concentrates will improve media compounding speed and manufacturability of Amgen’s next-generation biologics, the firm says. In 2014, Amgen opened a US$200 million (€168 million) next-generation production facility in Singapore intended to manufacture biologics with greater speed, productivity and flexibility. The model is being replicated at another facility under construction at Amgen’s West Greenwich, Rhode Island, campus. The two manufacturing plants are based on enabling technologies including single-use, modular design, and process intensification. Smaller Manufacturing but Larger Media Footprint…

GE Considers Broadening ‘Brilliant’ Approach to Media Manufacturing

GE Healthcare has implemented its Brilliant Manufacturing software at a plant in Utah, and says it is looking to broaden the analytics platform across its cell culture media network. In 2015, bioprocessing tools and equipment firm GE Healthcare launched its Brilliant Manufacturing Suite aimed at increasing production efficiency and optimization through analytical software. While offered as a service to its customers, the firm has also implemented the technology at its own facilities, including as part of a manufacturing transformation project…

J&J Repurposing US Site to Support CAR-T Manufacturing

Johnson & Johnson is renovating a facility in the US to make anti-cancer CAR-T candidate LCAR-B38M licensed from Legend Biotech last year. In December 2017, J&J subsidiary Janssen Biotech, Inc., entered into the chimeric antigen receptor (CAR) T-cell space through a US$350 million (€304 million) collaboration and licensing deal with Chinese firm Legend Biotech. Legend’s oncology candidate, LCAR-B38M, targets the B-cell maturation antigen (BCMA) and is under review in China. At the Goldman Sachs Annual Global Healthcare Conference earlier this…