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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 “always been a company that is multi-modality in really trying to address an unmet need in a number of diseases,” Shephard Mpofu, chief medical officer at Novartis Gene Therapies said yesterday. Highlighting the firm’s success in small and large molecules, he reminded delegates at Phacilitate’s Advanced Therapies…

Excellos: ‘There is no better time to enter cell therapy CDMO space’

by Dan Stanton

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 — announced during Phacilitate’s Advanced Therapies Week conference in Miami, Florida — already has an operational cGMP manufacturing facility for Advanced Therapies but according to CEO…

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

by Dan Stanton

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’ 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 – most recently Bristol-Meyer Squibb’s Breyanzi (liso-cel) and Abecma…

CBM and UPenn enter gene therapy manufacturing pact

by Dan Stanton

A five-year deal will see the Center for Breakthrough Medicines (CBM) gain commercial rights to certain gene therapy manufacturing and analytics platforms from the University of Pennsylvania. The King of Prussia, Pennsylvania-based contract development and manufacturing organization (CDMO) has entered a collaboration with the University of Pennsylvania Gene Therapy Program (GTP) to help small biotech firms, universities, and large pharma firms advance gene therapies through the clinic. The collaboration brings CBM access to UPenn’s gene therapy expertise, which has helped…

Lonza teams with Agilent to make cell therapy Cocoon platform ‘smarter’

by Dan Stanton

Lonza will work with Agilent to define the ideal Critical Quality Attributes (CQAs) for cell therapy manufacturing and help better control the in-process controls and analytics of its patient-scale Cocoon platform. Lonza’s Cocoon platform is a single system that can be used for a variety of different autologous cell therapy protocols, with each patient batch produced in a single disposable cassette customized to their specific process. The automated point-of-care manufatcuring system was developed by Octane Biotech, and though Lonza has…

With acquisitions integrated, Curia unveils mRNA offering

by Dan Stanton

CDMO Curia is leveraging recent acquisitions to offer end-to-end messenger RNA (mRNA) services, saying COVID-19 vaccines essentially served as proof of concept for the new modality. 2021 was an eventful year for contract development and manufacturing organization (CDMO) Curia. Along with a rebrand from its AMRI heritage, the company acquired LakePharma and Integrity Bio and – having integrated the entities into its business – has now launched a full mRNA service for its customers. “Curia has combined more than 30…

Cell and gene therapy exits from Sanofi and AvroBio

by Dan Stanton

Sanofi will focus its cell therapy strategy on allogeneic products, terminating its partnership with Sangamo. Meanwhile, disappointing trial results have driven AvroBio to abandon its lead gene therapy candidate for Fabry disease. The cell and gene therapy space continues to evolve but two announcements demonstrate the vicissitudes that linger over this burgeoning sector. Firstly, French Pharma giant Sanofi has ended a long-term hemoglobinopathies partnership with genomics firm Sangamo Therapeutics. “In its notice to Sangamo, Sanofi indicated that its termination relates…

Amgen: Not treating biosimilars as ‘stepchild’ is key to success

by Dan Stanton

Amgen says using the same development expertise and manufacturing capabilities for both its biosimilar and novel biologic programs sets it apart in the industry. Pharma firm Amgen is one of a handful of firms that has successfully invested in both innovator products and biosimilars – biologics that are very similar to reference biologics and for which there are no clinically meaningful differences in terms of safety, purity, and potency. With expected 2021 biosimilar revenues set to reach $2 billion, CEO…

New year, new gene therapy plants from Pfizer and Expression

by Dan Stanton

Christmas came early for Pfizer and Expression Therapeutics, which cut the ribbons on viral vector manufacturing plants in North Carolina and Ohio, respectively. Pfizer’s gene therapy division celebrated the new year with an expanded manufacturing footprint, having opened the first of three facilities at its site in Durham, North Carolina on December 15. The 85,500 square-foot plant will support clinical manufacturing of Pfizer’s gene therapy pipeline and represents an investment of $68.5 million by the firm. The facility will create…

Novartis to boost gene therapy pipeline through $800m Gyroscope buy

by Dan Stanton

Novartis will add a gene therapy candidate in Phase II trials for an advanced form of dry age-related macular degeneration through the addition of Gyroscope Therapeutics. Novartis will gain GT005, an Adeno-Associated Virus-2 (AAV)-based gene therapy candidate intended to be a one-time treatment for geographic atrophy (GA) – an advanced form of dry age-related macular degeneration (AMD) that leads to progressive and irreversible vision loss – through the proposed acquisition. Novartis is one of the leaders in the gene therapy…