Author Archives: Dan Stanton

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

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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…

January 25, 2022

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

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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…

January 24, 2022

HPNE to expand single-use capacity on back of $15m BARDA contract

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Funding from BARDA gives High Purity New England (HPNE) the opportunity to expand into its fourth facility, the bioprocess vendor says. HPNE has been contracted to produce pharmaceutical consumable equipment for the Biomedical Advanced Research and Development Authority (BARDA) and its third parties, issued in response to a Presidential Declaration of Public Health Emergency. The $15 million contract – number 75A50122C00009 – forms part of the office of the Assistant Secretary for Preparedness and Response at the US Department of…

January 20, 2022

CBM and UPenn enter gene therapy manufacturing pact

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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…

January 20, 2022

FDA 483 shows 7 observations at Catalent fill/finish plant in Belgium

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The publication of a US FDA Form 483 reveals failures to implement sustainable corrective action and preventive action, and inadequate maintenance at a Catalent fill/finish facility. Earlier this month, we broke the news that contract development and manufacturing organization (CDMO) Catalent received a Form 483 at its European syringe filling facility in Brussels, Belgium. While the issues observed allegedly caused disruption in the supply of Novo Nordisk’s weight loss drug Wegovy (semaglutide), specific details were sparse. But this week, the…

January 18, 2022

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

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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…

January 17, 2022

With acquisitions integrated, Curia unveils mRNA offering

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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…

January 14, 2022

Danaher: $10bn+ war chest in 2022 but sees no gaps in bioprocessing

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Danaher Corporation claims to be the leading player in bioprocessing and hopes to strengthen the offering further in 2022 through opportunist acquisitions. In 2021, Danaher Corporation spent over $10 billion in M&A deals. The bulk of the capital – $9.6 billion – was used to enter the contract development and manufacturing organization (CDMO) through the addition of Aldevron, though other deals in the life sciences space included the addition of lipid nanoparticle tech firm Precision Nanosystems (PNI). And discussing the…

January 13, 2022

2022 begins with proliferation of advanced therapy CDMO investments

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The Center for Breakthrough Medicines receives $350 million, Forge Biologics closes $80 million in additional funding, Piramal invests in Yapan, and GHO Capital invests in RoslinCT. Welcome to our CGT CDMO round-up. Eagle-eyed readers will remember South Korean investment firm SK Inc pledged to invest in Pennsylvania-based company the Center for Breakthrough Medicines (CBM) back in November. Now the cell and gene contract development and manufacturing organization (CDMO) has revealed SK’s involvement includes $350 million in equity financing aimed at…

January 11, 2022

Cell and gene therapy exits from Sanofi and AvroBio

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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…

January 11, 2022