Therapeutic Class

J&J taking ‘disciplined’ approach to CAR-T rollout

“CAR-T cell manufacturing is not a finished product,” says J&J EVP Mathai Mammen as he speaks about his firm’s rollout of recently approved myeloma therapy Carvykti. Last month, Johnson & Johnson received the regulatory thumbs up for its chimeric antigen receptor T-cell (CAR-T) therapy Carvykti ( ciltacabtagene autoleucel; ciltacel), developed with China-focused partner Legend Biotech. The therapy is the second BCMA CAR-T approval – Bristol-Myer Squibb’s Abecma (ide-cel) received FDA approval in March 2021 – and the first cell therapy success…

The 4 degrees of automation in cell therapy manufacture

With cell therapy firms looking beyond manual production methods, Cellares claims its ‘factory-in-a-box’ Cell Shuttle platform can offer the ultimate in walk-away automation on an industrial-scale. For years, industry has looked to automated processes to make cell therapies safely and at scale. Success has been variable, but developers continue investing in automated technologies to help make their complex therapies cost-effective. “A lot of people agree that automation is the way to go,” Fabian Gerlinghaus, co-founder and CEO of Cellares told…

Biovian to make AAVs for ANLBIO Alzheimer’s gene therapy candidate

CDMO Biovian Oy says it has the capacity to support viral vector needs through trials and beyond for ANLBIO from its Turku, Finland facilities. The deal sees biotech ANLBIO contract Biovian to support upcoming trials of its Alzheimer’s disease gene therapy candidate ANL-101. Financials have not been disclosed, but the Finnish contract development and manufacturing organization (CDMO) will supply GMP Cell Bank manufacturing, process and analytical development, and validation of product-specific analytical methods from its site in Turku. “This is…

Biocon buying Viatris biosimilar biz in $3.3bn deal

Indian drugmaker Biocon will add a portfolio of biosimilars – estimated to bring in $875 million in 2022 sales – through the planned acquisition. The deal, announced Sunday, will see Biocon Biologics pay up to $3.335 billion, made up of $2.335 billion in cash and $1 billion in Compulsorily Convertible Preference Shares (CCPS), for its partner Viatris’ biosimilars division. Viatris will own at least 12.9% of Biocon Biologics once the deal goes through. Kiran Mazumdar-Shaw, Biocon’s executive chair, described the…

eBook: Gene Therapies —
Developers Slowly Emerge from a Pandemic

This eBook gauges shifting expectations for the gene therapy industry amid the COVID-related uncertainties and clinical setbacks of the past couple years. BioProcess Insider founding editor Dan Stanton reports on the January 2022 Phacilitate Advanced Therapies Week event, specifically a standing presentation on the 10 most important industry drivers from the past year. Since 2017, advancements in gene therapies have featured prominently in these presentations. In 2021, gene therapies again made the list, but this time for more troubling reasons,…

Cell and gene sector needs regulatory clarity says Andelyn

Cell and gene therapy developers are still uncertain of regulator expectations according to Andelyn Biosciences, which says industry would benefit from more balanced oversight. Various agencies have invested a lot of effort in the development of regulatory frameworks for cell and gene therapy development and manufacture. Recent examples include the US FDA’s draft guidance on trialing multiple versions of a cell therapy and the EMA’s document on quality expectations for products containing genetically modified cells. While these efforts are a…

Abecma clocks $164m for Bristol-Myers but supply constraints remain

Bristol-Myers Squibb says it expects viral vector supply to ramp up later in the year as third-party and inhouse capacity come online. Bristol-Myers’ Abecma (idecabtagene vicleucel, commonly referred to as ide-cel) was approved in March 2021 as the first cell-based gene therapy for the treatment of multiple myeloma. “Abecma generated revenues of $164 million since its launch in May of last year,” David Elkins, Bristol-Myers’ CFO said during the firm’s fourth quarter call. “Revenues reflect very strong demand for the…

Oxford Biomedica enters US through $180m Homology JV

The UK-based gene therapy services firm and Homology Medicines will establish an adeno-associated virus (AAV) manufacturing and innovation joint venture. The deal, expected to close in the next few weeks, will see Oxford Biomedica pay biotech Homology $130 million upfront and invest $50 million in the new entity, ‘Oxford Biomedica Solutions.’ The UK-based gene therapy firm and contract development and manufacturing organization (CDMO) will take an 80% stake in the entity, while Homology will own 20% of the company. The…

Biogen pulling out of Bioepis JV in $2.3bn Samsung Bio deal

Samsung Biologics will take full ownership Samsung Bioepis 10 years after forming the biosimilar developer with Biogen. In 2012, the relatively new contract development and manufacturing organization (CDMO) Samsung Biologics teamed up with Biogen Idec (now just Biogen) to form a joint venture aimed at developing, manufacturing and marketing biosimilars: Samsung Bioepis. Over the past decade, the share of the entity has shifted – Samsung Biologics began with an 85% share, which later increased to 94.6% before Biogen paid $670…

2021 CGT moments: First place for second line CAR-T

Advancements in CAR-T development and access, in vivo gene editing, and CDMO M&A all feature in Propel BioSciences’ Susan Nichols top 10 advanced therapy moments of 2021.  After two years away, BioProcess Insider attended the highly anticipated presentation at Phacilitate’s Advanced Therapies Week in Miami, Florida, where Susan Nichols (CEO of Propel BioSciences) highlighted 10 moments from 2021 that defined and drove the cell and gene therapy (CGT) space.  Some unexpected milestones made the list, such as the arrival of messenger…