Author Archives: Gareth Macdonald

Orgenesis teams with Johns Hopkins’ in first post Masthercell sale PoC deal

Johns Hopkins University will use Orgenesis’ point-of-care processing technology for cell and gene therapy research in a collaboration announced this week. The US research University has licensed access to Orgenesis’s ‘point-of-care’ (PoC) platform which – as the name suggests – is used to develop and process cell therapies in the clinic Orgenesis CEO Vered Caplan said, “Our POCare platform is designed to provide unique cell and gene therapy solutions in a cost effective, high quality and scalable manner, using closed…

First J&J, now Sanofi teams with BARDA to tackle coronavirus

Sanofi Pasteur has joined Johnson & Johnson as the second firm to team up with BARDA to take on coronavirus (COVID-19). According to a statement, Sanofi Pasteur will use recombinant DNA tech to make a vaccine against the virus that has sickened tens of thousands and resulted in hundreds of deaths since it emerged in China last year. The plan is to use the Sanofi technology to reverse engineer proteins isolated from the virus to produce DNA sequences. These sequences…

Manufacturing quality systems first defense against hackers says expert

An effective quality management system is a must for biopharmaceutical firms looking to protect their data assets against hackers according to a leading cybersecurity expert. Increasingly biopharmaceutical manufacturing relies on data. Ensuring optimal conditions are maintained in bioreactors or that chromatography systems are functioning properly depends on monitoring systems that feed information back to control systems. Likewise, data is key to how biopharmaceutical products are tracked through packaging and distribution systems to ensure they get to the correct hospital, pharmacy…

Teva highlights fasinumab and Celltrion biosims deal as drivers

Teva says the monoclonal antibody (mAb) candidate fasinumab has “big potential” and expects to see Phase III data this year. The Israel headquartered generics firm spoke about fasinumab – the osteoarthritis pain drug – during its fourth quarter earnings call last week. CEO Kare Schultz told analysts “In novel biologics, we have a lot of different things going on. “The most exciting short-term is fasinumab that we are developing together with Regeneron and where we hope to see data this year…

Bio-Rad optimistic about 2020 despite $20m impact of Q4 cyber-attack

Bio-Rad Laboratories expects to recover 25% of the revenue shortfall resulting from the cyber-attack it suffered in Q4. The US research and clinical diagnostic reagents firm made the prediction during a conference call this week. CFO Ilan Daskal told analysts “Fourth quarter revenue fell short by about $20 million from the midpoint of our guidance, mainly due to the cyber-attack that we reported in early December. He added, “We expect to recover in Q1 of 2020 about $5 million of…

Co.don wins MukoCell contract to make urology cell therapy

MukoCell GmbH has hired Co.don AG to manufacture its autologous cell-based treatment for urological disorders. The deal will see Co.don make the product – also named MukoCell – at its recently established human cell-focused manufacturing facility in Leipzig, Germany. Matthias Meißner, Co.don director of corporate communications, told us MukoCell “is an innovative and gentle method for the surgical repair of urethral strictures.” A urethral stricture is a narrowing of the urethra caused by injury, instrumentation, infection, and certain non-infectious forms of urethritis. MukoCell…

Dupixent growth increases Regeneron’s manufacturing costs (again)

Regeneron says higher Dupixent (dupilumab) sales drove an increase in manufacturing and collaboration costs in Q4. In the US, Dupixent brought in revenue of $605 million (€554 million) in the final three months of 2019, up 136% on the comparable period a year earlier. Similarly, global net sales of the drug in the fourth quarter increased to $752 million, up from $319 million in 2018. Regeneron senior vice president Marion McCourt told analysts: “We continue to see strong prescribing trends…

Liso-cel safety data bodes well as BMS tackles CAR-T headwinds

Concerns about CAR-T safety continue to be a challenge for the sector according to Bristol-Myers Squibb, which outlined plans to address such “headwinds” during a Q4 call. Bristol Myers Squibb (BMS) spoke about the chimeric antigen receptor (CAR) T-cells sector last week, explaining while the market for such therapies is expanding, growth rates are not as fast as they could be. Nadim Ahmed, president of BMS hematology department, told analysts: “Clearly, there have been some headwinds in the [CAR-T] marketplace and…

Celltrion pulls plant team out of Wuhan as it tracks coronavirus

Celltrion says it is committed to a biosimilars plant in Wuhan, China but has pulled project team out while it tracks the 2019-nCoV coronavirus outbreak. Celltrion is keeping a close eye on the spread of 2019-nCoV according to a spokesman. He told us “while we remain strongly committed to the project, it is difficult to say how the ongoing outbreak will affect our plans at this moment. “We are closely monitoring the situation and will continue to communicate with the…

Akron says biopharma needs GMP framework for ancillary materials

Akron Biotechnology says biopharma needs a common GMP framework for ancillary materials used in the production of advanced therapies Ancillary materials (AMs) are components and reagents used during cell therapy production. They are not supposed to be present in the finished products, but often are which can impact quality and safety. Despite this, at present there are no specific regulations governing the composition, compliance, and qualification of AMs. Instead there are several independent GMP frameworks for such materials. These include…