Author Archives: Millie Nelson

J&J halts Carvykti UK launch but is manufacturing to blame?

Patient advocacy group Myeloma UK believes supply issues have caused Johnson & Johnson to not progress its CAR-T cell treatment Carvykti (ciltacabtagene autoleucel) in the UK.  In March 2022, the US Food and Drug Administration (FDA) granted authorization for Carvykti, a chimeric antigen receptor (CAR) T-cell therapy developed by Johnson & Johnson (J&J) and its partner Legend Biotech, to treat white blood cell cancer. The treatment was being assessed in the UK by the National Institute of Health and Care…

Great Ormond Street Hospital and Leucid ink CAR-T manufacturing deal

Great Ormond Street Hospital (GOSH) has agreed to manufacture Leucid Bio’s lead asset, LEU011 at the Zayed Center for Research in London, UK. Leucid, a UK clinical stage biotech firm, which is focused on developing chimeric antigen receptor T-cell (CAR-T) therapies using its lateral CAR platform to treat refractory cancers, has collaborated with GOSH to manufacture LEU011, a lateral CAR targeting NKG2D ligands, for use in human clinical studies. “We decided to partner with GOSH to manufacture our CAR T-cell…

Flexibility is key when designing a CGT facility, says expert

There are obvious reasons a special design needs to be applied to the design of a cell and gene therapy (CGT) facility and flexibility is one of them, says Scitech Engineering. With increasing demand for capacity and capability in the CGT space and the US Food and Drug Administration (FDA) predicting that there will be 25 newly approved products by 2025, Ali Bahari, bioprocess design consultant at Scitech Engineering said it is no surprise that “lots of places are [adopting]…

Pfizer to acquire Seagen for $43 billion

After weeks of speculation, Pfizer has agreed to acquire antibody-drug conjugate (ADC) developer Seagen for $43 billion.  The potential acquisition of Seagen (previously Seattle Genetics) has been circulating news outlets since June last year when the Wall Street Journal reported Merck & Co. was eyeing the Bothell, Washington based firm to increase its oncology offering.   Most recently, the same outlet reported Pfizer was considering purchasing the ADC manufacturer, to which Mike Vandiver, executive director at Seagen, told BPI West delegates the rumored deal “is just noise,…

GTP Bioways and Texcell join forces to expand drug development offering

CDMO GTP Bioways and CRO Texcell have partnered to provide a “one stop shop” for biopharma customers outsourcing their molecules. The two French players have partnered , combining clinical research organization (CRO) TexCells’ biopharmaceutical process development and manufacturing  together with contract development manufacturing organization (CDMO) GTP’s knowledge of viral testing, viral clearance, and bioassays. “Their complementary services of testing and development and manufacturing provides a ‘one-stop-shop’ for biopharmaceutical clients that are outsourcing the development of their molecules,” a spokesperson for…

Danaher partners with UPenn to advance cell therapy tech

The partnership aims to develop technologies to tackle manufacturing bottlenecks in the delivery of engineered cell products. The multi-year partnership between Danaher Corporation and the University of Pennsylvania (UPenn) looks to improve the consistency of clinical outcomes for patients by addressing manufacturing challenges associated with cellular immunotherapies. Both parties said the collaboration is driven by the scale of clinical development identified in the CAR-T cell therapy space. There are six US Food and Drug Administration (FDA) approved CAR-T cell therapies:…

Adaptimmune merges with TCR² Therapeutics

The stock for stock transaction will see Adaptimmune shareholders own 75% of the combined company, which will target solid tumors. The deal, which is expected to close in the second quarter of 2023,  sees Adaptimmune and TCR² Therapeutics merge to create a cell therapy company for solid tumors through the use of their respective technology platforms. “This strategic combination brings together two culturally aligned companies at the forefront of the field to create a preeminent cell therapy company for solid…

Tallying the costs of RNA vs AAV at BPI West

RNA vaccine manufacturing has lower CAPEX but higher operational costs than AVV vaccine production, says an expert at BPI West.   Messenger (mRNA) was thrusted into the limelight through the success of Moderna and BioNTech/Pfizer’s respective COVID-19 vaccines. Their approvals have helped bring confidence to the mRNA sector and drive investment in wider RNA technology platforms.  But despite its success, the RNA space still has many challenges to overcome and comparisons to other modalities are heavily debated. Zoltan Kis, lecturer at…

Seagen on rumored Pfizer deal: ‘It’s all noise, until it isn’t’

Pfizer is the latest company rumored to be buying antibody-drug conjugate (ADC) developer Seagen, but Seagen says the deal is all noise… until it isn’t.   The potential acquisition of Seagen (previously Seattle Genetics) has been circulating news outlets since June last year when the Wall Street Journal reported Merck & Co. was interested in buying the Bothell, Washington to increase its oncology portfolio and pipeline. Last week, the same outlet reported Pfizer is considering purchasing the ADC manufacturer.   While the deal is speculative…

Facility buildout does not always begin with bricks, says Genentech

The buildout of a facility ends with technology choices but starts with a purpose, vision, and people, says Roche’s Genentech.   Genentech — part of the Roche Group — broke ground on a $450 million expansion at its Oceanside, California site in February 2023; a site it says will work in unison with the recently completed $250 million Clinical Supply Center in South San Francisco (SSF).  But when thinking about building a facility, the question “where are we going with the…