Tag Archives: Manufacturing

Cellectis Anticipates Submitting Multiple Undisclosed INDs Within 12 Months; No Clinical Updates for 3 UCART Programs; Cellectis Q4 2020 Earnings Call Summary

On Friday, March 5, Cellectis held their Q4 2020 earnings call (press release / no slides presented). Cellectis commented on their 3 ongoing clinical trials and the anticipated submission of multiple INDs for undisclosed CAR-T products within the next 12 months. Of note, management outlined their strategic approach to cell therapy development and licensing. Below, Celltelligence provides insights on Cellectis’s strategic approach to collaborations and manufacturing.

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The Celltelligence team has combined experience in oncology, including cell therapy, CAR-T, immunology, microbiology, biochemistry, and other various fields in life sciences. Our team members include PhDs, industry veterans, and analysts tuned to The Street – all of whom help to create a more actionable service of delivering cell therapy intelligence.

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Kymriah’s First Commercial Manufacturing Facility Approved in Australia; Novartis Increases Manufacturing Footprint to Six Global Centers

On Friday, February 12, Novartis announced (press release) that the Peter MacCallum Cancer Center in Melbourne has been approved by the Therapeutic Goods Administration (TGA) to commercially manufacture Kymriah. Below, Celltelligence provides thoughts on the impact of Novartis’s manufacturing footprint strategy and anticipated manufacturing approval in China.

About The Author

The Celltelligence Team

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Content Leads & Contributors

The Celltelligence team has combined experience in oncology, including cell therapy, CAR-T, immunology, microbiology, biochemistry, and other various fields in life sciences. Our team members include PhDs, industry veterans, and analysts tuned to The Street – all of whom help to create a more actionable service of delivering cell therapy intelligence.

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Kymriah’s First Asian Commercial Manufacturing Facility is Approved; Novartis Increases Manufacturing Footprint to Five Global Centers

On Friday, October 30, Novartis announced (press release) that they have received marketing authorization from Japan’s MHLW (Ministry of Health, Labor and Welfare) for the FBRI (Foundation for Biomedical Research and Innovation) to commercially manufacture Kymriah. Below, Celltelligence provides thoughts on the impact of Novartis’s Japanese manufacturing site and anticipated approvals in other locations.

About The Author

The Celltelligence Team

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Content Leads & Contributors

The Celltelligence team has combined experience in oncology, including cell therapy, CAR-T, immunology, microbiology, biochemistry, and other various fields in life sciences. Our team members include PhDs, industry veterans, and analysts tuned to The Street – all of whom help to create a more actionable service of delivering cell therapy intelligence.

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Gilead Announces EMA Approval for End-to-End Yescarta CAR-T Manufacturing at Amsterdam Facility

On Friday, June 12, Gilead announced (press release) that the European Medicine Agency (EMA) has approved the company’s Amsterdam facility for end-to-end manufacturing of Yescarta. Below, Celltelligence highlights the potential impact on Yescarta’s EU turn-around-time (TAT), and the effect this may have on Kymriah sales.

About The Author

The Celltelligence Team

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Content Leads & Contributors

The Celltelligence team has combined experience in oncology, including cell therapy, CAR-T, immunology, microbiology, biochemistry, and other various fields in life sciences. Our team members include PhDs, industry veterans, and analysts tuned to The Street – all of whom help to create a more actionable service of delivering cell therapy intelligence.

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