Author Archives: Dan Stanton

Vertex doubles down on Massachusetts CGT capabilities

Vertex Pharmaceuticals announced it will build a 344,000 square-foot facility during the dedication of its Center for Cell and Genetic Therapies building in Boston this week. Vertex became a serious player in the advanced therapy space in 2019 through a series of deals, including the $245 million acquisition of Duchenne muscular dystrophy and myotonic dystrophy type 1 gene therapy developer Exonics, and the $950 million acquisition of type 1 diabetes stem cell developer Semma Therapeutics. The same year, the firm…

FDA issues draft guide to tackle supply chain disruptions

The FDA says that implementing risk management principles should be applied throughout the drug supply chain to help mitigate the risk of shortages. “Today’s draft guidance is an important step in what the nation needs to achieve an increasingly secure and resilient drug supply,” the US Food and Drug Administration (FDA) said in a statement. “For Americans to have access to an uninterrupted supply of safe, effective and high-quality drugs, all entities involved in the manufacture of a drug should…

Cell and gene therapy processing: Iteration or innovation?

Cell and gene therapies represent the “next evolutionary step” in bioprocessing incorporating disruptive technologies on a well-proven manufacturing base, agree panelists at BPI Europe. “Is is cell and gene therapy really the shiny, bright object on the field that breaks all the rules and disrupts everything? Or is it just an iteration of the same principles that we had before, with slightly different practices?” That was the question Nadine Ritter, president and analytical advisor at Global Biotech Experts posed to…

Avantor and Cytovance team to address $1.5bn plasmid DNA market

The advanced therapy pipeline is driving demand says Avantor, which has collaborated with Cytovance to offer an expanded plasmid DNA service.  “The demand for plasmid DNA, especially at cGMP-grade, supporting advanced therapeutic modalities is growing rapidly,” said Ger Brophy, EVP of Biopharma Production at Avantor.  He told BioProcess Insider it is being driven by the growing, early-stage pipeline of cell and gene therapies, DNA and RNA vaccines, and gene editing technologies. “We estimate that the total addressable market for plasmid DNA…

CAR-T approvals marred by autologous manufacturing limitations, says Allogene

Autologous therapies have not kept up with demand says Allogene Therapeutics, which claims only off-the-shelf cell therapies can serve larger patient populations. While the approval of Novartis’ Kymriah (tisagenlecleucel) in 2017 marked a breakthrough for chimeric antigen receptor (CAR) T-cell therapies, the sector has been slow to blossom. However, the past year or so has seen some breakthroughs in the space: Approvals for Bristol-Myers Squibb’s Breyanzi (liso-cel) and Abecma (ide-cel), and J&J’s Carvykti (ciltacel). Meanwhile, last month Gilead’s Yescarta (axicabtagene…

ALSA latest VC firm to contract Lonza to service its portfolio

Lonza says small to mid-sized companies represent the bulk of its customers as it adds ALSA Ventures’ biopharma portfolio to its client list. European biotech investment firm ALSA has contracted Lonza to help develop and manufacture molecules within its biologics and small molecule company portfolio. The deal, financials of which have not been divulged, will see ALSA’s portfolio companies – which include Promatix, Montis Biosciences, Epsilogen, and Oxford BioTherapeutics – leverage Lonza’s development and manufacturing services and network, along with…

Emergent ditched 400m vaccines amid quality and staff issues, report finds

Emergent BioSolutions hid evidence of contamination and destroyed nearly 400 million doses of J&J and AstraZeneca vaccines, a US Government staff report has found. Emergent was one of the benefactors from the US Government’s efforts in countering COVID-19, winning a Trump Administration contract worth $628 million to make the Johnson & Johnson (J&J) and AstraZeneca vaccines. However, the contract development and manufacturing organization (CDMO) was hit with an FDA Form 483 and a directive to stop production at its Bayview,…

Dover shells out $225m for bio-control instruments firm Malema

Biomanufacturing vendor Dover will bolster its Pumps & Process Solutions segment via the addition of Malema’s single-use flow sensor technology. The $225 million cash deal, expected to close in the second quarter, sees Dover add flow-measurement and control instruments maker Malema Engineering Corporation to its service offering. Malema, which is set to make approximately $40-45 million in sales in 2022, produces single-use flow sensors using Coriolis technology which it claims reduces the potential for measurement error and the need for calibration…

Cytiva opening Swiss single-use cell processing site

With work beginning weeks before the global pandemic, the plant has opened on schedule, boosting Cytiva’s capacity for single-use products aimed at supporting cell and gene therapy makers. The 7,400 m2 facility in Grens, Switzerland is set to have its official opening at the end of the month, strengthening bioprocess vendor Cytiva’s capabilities in providing single use kits for cell processing systems and their relevant consumables. The plant is ready 28 months after Cytiva – then known as GE Life…

Regenxbio: ‘CDMO issue validates inhouse gene therapy investment’

Regenxbio will begin inhouse production of material for its Duchenne Muscular Dystrophy (DMD) gene therapy after a quality issue at a third-party manufacturer delayed clinical trial dosing. The initiation of dosing adeno-associated viral (AAV) based gene therapy candidate RGX-202 for a Phase I/II clinical trial has been delayed by between six and 12 months, Regenxbio announced last week during its first quarter 2022 financial results. According to CEO Ken Mills, the delay is due to an issue at an undisclosed contract…