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Gene Therapy’s Next Big Challenge: Manufacturing

 
• By Amanda Micklus

As the pipeline and market for novel cell and gene therapies expands, it is time for drug developers to address other critical aspects in the logistical chain – and for these complex therapies a lot of those issues relate to manufacturing. Looking at specific cases, In Vivo has underlined the main manufacturing challenges facing cell and gene therapy developers, and highlighted methods and approaches being used to generate solutions. 

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Commercialization of modern-day gene therapies is now a reality. Next-generation modalities such as chimeric antigen receptor T-cell (CAR-T) therapies are fully in launch mode in the US, where Novartis AG and Gilead Sciences Inc. are banking on the success of their one-time hematological cancer treatments Kymriah (tisagenlecleucel) and Yescarta (axicabtagene ciloleucel), respectively. Final approval of those CAR-T therapies has also occurred in the EU, with funding arrangements in place in the UK. In addition, the first in vivo gene therapy for an inherited disease is now available in the US, by way of Spark Therapeutics Inc.'s Luxturna (voretigene neparvovec - rzyl), and the EMA is currently evaluating what could be the next approval in the market, bluebird bio’s LentiGlobin (lentiviral beta-globin gene transfer) for transfusion-dependent beta thalassemia.

Presently, there are 25 unique gene therapies that have reached Phase III or have been filed for approval. Approximately 33 individual Phase III trials involving these therapies are ongoing (open,...

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More from Outlook Archive

Big Three Lead From The Front With Medtech Back On Solid Growth Footing

 
• By Ashley Yeo

Abbott Laboratories and Johnson & Johnson joined Medtronic in putting a clear distance between themselves and other global medtechs in the Top 10 by revenues for 2021. Post-COVID-19 procedure growth, and, for Abbott, a strong rebound in non-COVID diagnostic demand, were key drivers.  

Infographic: Top 100 Pharma Companies

 
• By Lucie Ellis-Taitt

The Scrip 100 universe gathers FY2021 financial performance data and compares the activities of the top 100 biopharma businesses, ranked by pharma sales.    

Pfizer Leads An Unusual Year For The Scrip 100

 
• By Jessica Merrill

Pfizer catapulted back into the lead in the pharmaceutical rankings on the strength of COVID-19 revenues while BioNTech and Moderna both made the list for the first time.      

Outlook 2023: The Pharma Rollercoaster Shows No Signs Of Slowing Down

 
• By Jo Shorthouse

What will 2023 bring as the industry faces one of the toughest periods in the last decade? In Vivo asked three industry experts for their views.

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Investor Optimism Ahead As Big Medtech Proves ‘It’s All About Value’

 
• By Ashley Yeo

Pressure to exploit connected care functionality is accelerating the shift in care delivery away from the inpatient setting. Medtechs are reshaping to maximize faster-growth opportunities.

2024’s Busiest Dealmakers: Novartis Laps The Field, While Lilly, Sanofi Keep Busy

 
• By Joseph Haas

Nine biopharma companies made 12 or more deals, with Novartis inking 21 deals and leading M&A activity. Roche, meanwhile, spent little up front but maintained a hectic pace with 12 alliances.

Big Pharma Headcounts: Obesity Leaders Bulk Up As Others Go Lean

 
• By Andrew McConaghie

As Eli Lilly and Novo Nordisk reap the blockbuster rewards of their rival obesity therapies the companies are also bulking up their organizations to make the most of the phenomenal rise of the GLP-1 class.