Therapeutic Class

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 Recent examples include the US FDA‚Äôs draft guidance on trialing multiple versions of a cell therapy and the EMA‚Äôs document on quality expectations for products containing genetically modified cells.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‚Äô Abecma (idecabtagene vicleucel, commonly referred to as ide-cel) was approved in March 2022 as the first cell-based gene therapy for the treatment of multiple myeloma. ‚ÄúAbecma generated revenues of $164 million since its launch in May of last year,‚ÄĚ David Elkins, Bristol-Myers‚Äô CFO said during the firm‚Äôs fourth quarter call. ‚ÄúRevenues 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, ‚ÄėOxford Biomedica Solutions.‚Äô 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 ‚Äď 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‚Äô Susan Nichols top 10 advanced therapy moments of 2021.¬† After two years away, BioProcess Insider attended the highly anticipated presentation at Phacilitate‚Äôs¬†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…

CDMO Arranta buys Cytiva single-use tech for mRNA production

Live biologics CDMO¬†Arranta¬†Bio has bought a single-use manufacturing platform from¬†Cytiva¬†for the production of¬†mRNA vaccines.¬† The purchase is part of a $110 million investment by¬†Arranta¬†at its manufacturing and development facility in Watertown, Massachusetts. The CDMO also plans to open a¬†dedicate¬†space for lipid nanoparticle formulation¬† Joe Makowiecki from¬†Cytiva, told us ‚ÄúThis is the first¬†FlexFactory¬†for an mRNA product,‚ÄĚ adding that it will¬†‚Äúprovide¬†Arranta¬†the flexibility to manufacture mRNA vaccines and therapies from in vitro transcription (IVT) to drug product aseptic fill. ‚ÄĮ¬† He predicted that…

Novartis looks to gene therapy 3.0 with an eye on lowering COGS

Novartis is confident the manufacturing costs of gene therapies will fall as it improves processes and brings on board next generation technologies such as CRISPR and gene editing. Swiss Pharma giant Novartis has ‚Äúalways been a company that is multi-modality in really trying to address an unmet need in a number of diseases,‚ÄĚ Shephard Mpofu,¬† chief medical officer at Novartis Gene Therapies said yesterday. Highlighting the firm‚Äôs success in small and large molecules, he reminded delegates at Phacilitate‚Äôs Advanced Therapies…

Excellos: ‚ÄėThere is no better time to enter cell therapy CDMO space‚Äô

With the¬†San Diego Blood Bank at its foundation and $15 million of funding in hand,¬†Excellos¬†launches itself in the cell therapy¬†contract¬†manufacturing¬†sector.¬† A new contract development and manufacturing organization (CDMO) has arisen in San Diego, California this week: Excellos Incorporated, which officially launched on the back of $15 million in growth funding from Telegraph Hill Partners (THP).¬† The new entity ‚ÄĒ announced during¬†Phacilitate‚Äôs¬†Advanced Therapies Week¬†conference in Miami, Florida ‚ÄĒ¬†already has an operational cGMP manufacturing facility for Advanced Therapies but according to CEO…

Limula on the future of cell therapies: Closed, automated, decentralized

An in-situ centrifugation-based point-of-care system could help push industry towards the decentralized and automated model needed to make cell therapies affordable and reliable, according to Limula Biotech. The approval of Novartis‚Äô Kymriah (tisagenlecleucel) in 2017 was a milestone in the advanced therapy space, marking the arrival of the first genetically-modified autologous T-cell immunotherapy to the market. Since then, a handful of other autologous cell therapies have received the regulatory thumbs up ‚Äď most recently Bristol-Meyer Squibb‚Äôs Breyanzi (liso-cel) and Abecma…