Author Archives: Dan Stanton

Univercells $19m Booster Shot to Help Disrupt Vaccine Industry

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…

‘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…

FDA Guidelines Show ‘Growing Maturity’ of Gene Therapy Space, Says Industry

The US FDA has published six draft guidance documents related to gene therapies. The inclusion of manufacturing guidelines will help modernize the commercialization process to keep pace with the growth technology, say industry groups. Over the past 12 months, the US food and Drug Administration (FDA) has approved three separate gene therapy products: Novartis’ Kymriah (tisagenlecleucel), Gilead/Kite’s Yescarta (axicabtagene ciloleucel), and Spark Therapeutics’ Luxturna (voretigene neparvovec). And with a growing number of gene therapies moving through the clinic – there…

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…

Still Space for Multiple Neulasta Biosimilars, says Pfenex

Pfenex has deprioritized its pegfilgrastim biosimilar program but is reevaluating the market after Mylan’s recent success in the US. In June, the US Food and Drug Administration approved Mylan’s Fulphilia on its second attempt. While Fulphilia has become the first biosimilar of Amgen’s cancer drug Neulasta (pegfilgrastim), there are several other firms looking to tap the market, including Coherus and Novartis subsidiary Sandoz. Clinical-stage development and licensing biotech Pfenex too has a pegfilgrastim biosimilar in its pipeline, PF529, but announced…

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…

Therapy First, Efficiency Second: Why We Should Stop Focusing on Manufacturing Costs

Drug substance manufacturing only contributes around 5% on average to the total cost of a biologic says GE Healthcare’s Guenter Jagschies. Payors, patients and governments are increasingly looking to industry to justify the high prices of prescription drugs. As new immuno-oncology treatments are being launched with increasingly higher price tags and often the cost of producing these complex biotherapeutics. “This industry is not pricing based on cost, it is pricing based on perceived value,” Guenter Jagschies, senior director of strategic…