Bluebird Bio’s suspension of trials of its sickle cell gene therapy LentiGlobin has put the vector used to make it in the spotlight. The US biotech announced the temporary suspension of two LentiGlobin trials – specifically HGB 206 NCT02140554 and HGB 210 NCT04293185 – this week. It said the measure was prompted by reports a patient in group A of the Phase I/II HGB-206 study treated with the therapy five years ago had developed acute myeloid leukemia (AML). Bluebird also…
COVID-19 has increased demand for viral vectors, exacerbating concerns that supply constraints could slow the growth of the cell and gene therapy sector. The ability to insert genetic material into cells using viral vectors is a cornerstone of the modern biopharmaceutical industry. Vectors are used to make everything from cell lines used to produce therapeutic proteins and monoclonal antibodies (mAbs) though to cell and gene therapies. Mismatch As a result, biopharma industry demand for vectors is strong. Indeed, a study…
Bristol Myers-Squibb (BMS) has set a 24-day production target for Breyanzi and set up a digital platform to let physicians and patients track manufacture of the lymphoma cell therapy in real-time. The US Food and Drug Administration (FDA) cleared Breyanzi (lisocabtagene maraleucel; liso-cel) for the treatment of adults with relapsed or refractory (R/R) large B-cell lymphoma this month. A BMS spokeswoman told us “BMS plans to manufacture Breyanzi for each individual patient at its state-of-the-art cellular immunotherapy manufacturing facilities, initially…
German CDMO Rentschler will set up manufacturing capabilities at the UK’s Cell and Gene Therapy (CGT) Catapult, launching itself into the regenerative medicine space. Family-owned contract development and manufacturing organization (CDMO) Rentschler offers mammalian manufacturing and fill and finish services for biologics but has now expanded into cell and gene therapy production through a deal with the CGT Catapult, based in Stevenage, UK. Rentschler will establish its manufacturing capabilities – including adeno-associated virus (AAV) vector production – through “a significant…
Roche outlines ‘higher than originally expected’ sales impact from biosimilars worldwide. Roche announced in full year results for 2020 that biosimilars to Herceptin (trastuzumab), Avastin (bevacizumab), and MabThera/Rituxan (rituximab) dented sales by CHF 5.7 billion ($6.34 billion) worldwide. Roche group’s CEO, Severin Schwan, commented in an investor call after the results were revealed that “the impact of biosimilars was significant, somewhat higher than we originally expected.†As a result, sales in the company’s pharmaceuticals division decreased by 8% to CHF…
Rentschler Biopharma is poised to begin large-scale production of CureVac´s candidate COVID-19 vaccine, CVnCoV. Meanwhile Bayer will ramp up production, and GSK is on board to make a further 100 million doses this year. Rentschler, a German contract development and manufacturing organization (CDMO) announced it is gearing up to start commercial production at its Laupheim facility this week. It said it is optimizing the process to increase mRNA yield, adding it expects to produce more than 100 million doses per…
Cell bank firm Rooster Bio has teamed with Sartorius to find ways of scaling-up production of stem cell-based regenerative therapies. The collaboration will combine Rooster’s human mesenchymal stem/stromal cell (hMSC) working cell banks and media systems with Sartorius’ single-use manufacturing tech, process control software and analysis tools. The aim is to provide “robust, streamlined, end-to-end platform technologies and protocols that can be implemented for rapid scale up of manufacturing processes, allowing product developers to significantly speed up their development timelines, 
COVID-19 has caused regulatory inspection delays, operational slowdowns and lower consumption, diminishing Biocon’s aspiration of reaching $1 billion in annual biosimilar revenues. On paper, Biocon’s third quarter FY21 was positive. Sales grew 7% year-on-year to INR 1,879 crore ($258 million), with an 11% growth in biosimilars contributing INR 769 crore to the total. Quarter-over-quarter, biosimilar sales grew 14%, and Biocon’s presence in marketed biosimilars further grew with a number of approvals across various jurisdictions, including EMA recommendation for its insulin…
Cognate plans to increase capacity in Europe four-fold and to double existing capacity at its US site. This time last year, Cognate Bioservices completed the acquisition of Cobra Biologics, adding its plasmid and viral vector manufacturing capabilities to its own cell therapy services. Cognate began this year with another announcement, it would be adding to its subsidiary’s manufacturing capacity through an investment in Europe, alongside bolstering its existing facilities in the US. The European expansion will see Cobra quadruple capacity…
Three organizations have created ScaleReady to provide a ‘cost-effective’ cell and gene production platform. The joint venture combines the capabilities of Bio-Techne, Fresenius Kabi, and Wilson Wolf, which each take an equal share in the newly created business. ScaleReady will offer technologies for cell culture, cell activation, gene editing and cell processing developed separately by these companies. The joint venture business itself will provide the sales, marketing, and application support for the cell and gene therapy manufacturing platform created by…