Author Archives: Gareth Macdonald

Gamida’s off-the-shelf lymphoma cell therapy set for trials after hold lifted

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The US FDA has released Gamida Cell from a clinical hold imposed last year, clearing the way for trials of GDA-201, a candidate off-the-shelf treatment for large B cell lymphomas. The Boston biotech firm announced the decision last week, also revealing that the US regulatory agency cleared its investigational new drug (IND) application for the product. CEO Julian Adams said, “FDA clearance of our IND for the cryopreserved formulation of GDA-201 represents a significant milestone for the company and reflects…

May 3, 2022

ATMPS gets US patent for blockchain for personalized meds

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US authorities have granted ATMPS Ltd a patent for the use of blockchain technologies in the delivery of personalized medicines. ATMPS’ technology – known as Hataali – is designed to track personalized medicines from “vein to vein,†in other words from the initial harvesting of cells from a clinical trial participant to the production facility and back through a series of nodes. CEO Raja Sharif told us “Hataali is an incredibly flexible platform with a large array of potential uses…

May 2, 2022

Gene therapy sector needs tech to meet regulatory requirements

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Manufacturing rules are a major challenge for gene therapy firms according to researchers, who say industry needs better tech to meet regulatory requirements. The call for better technology came in a new study published in the journal Molecular Therapy earlier this month, in which progress seen in the cell therapy space was compared with the slower growth of the commercial gene therapy market. “Cell-based therapies have revolutionized the treatment of some blood cancers… Gene therapy, on the other hand, has…

April 19, 2022

Cash strapped Bluebird cuts staff and focuses on late stage gene therapies

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Bluebird Bio is cutting its workforce and prioritizing late phase gene therapy projects to reduce costs. The US biotech announced the staff cuts this week, explaining the aim is to deliver up to $160 million in operational savings over the next two years. It did not share further details. At the start of the year, Massachusetts-based Bluebird said it employed 518 people, 330 of whom work in R&D with 188 engaged in commercial, finance, legal, business development, human resources, information technology,…

April 8, 2022

15 year follow-up for gene editing outlined in FDA draft guide

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The US FDA has set a 15 year follow-up period for therapeutic gene editing and edited products in new draft guidelines. The guidance – available here – covers therapeutic use of gene editing techniques like ZFN, and CRISPR, as well as gene therapy products made using those techniques. The aim, according to the FDA, is “to assist in the translation of these products from the bench to clinical trials, this guidance includes recommendations for how to assess the safety and…

March 22, 2022

CRL forecasts manufacturing business growth in 2022

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Revenue from Charles River Laboratories’ manufacturing business increased significantly in 2021 thanks to increased demand and the positive impact of acquisitions. Charles River Laboratories’ (CRL’s) revenue for 2021 increased 21.1% to $3.54 billion. Its discovery and safety assessment unit made the biggest contribution, bringing in $2.11 billion which is 14.7% more than in 2020. Revenue from research models and services climbed 20.9% to $690.4 million. However, in terms of growth, CRL’s manufacturing and related services business gained the most ground.…

February 28, 2022

Carsgen’s US CAR-T plant open for business

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Carsgen Therapeutics’ new facility in North Carolina is poised to begin making candidate CAR-T cell therapies for trials after passed an inspection. The facility in Research Triangle Park (RTP) – which official opened this week – was issued with a certificate of compliance after being visited from inspectors from Durham city council. Company president Richard Daly welcomed the decision as an important expansion of Carsgen’s manufacturing network. “RTP manufacturing facility plus two Carsgen existing GMP facilities in Shanghai, China will enhance our…

February 24, 2022

Immunity pays $40 million to take on Athenex manufacturing plant

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Immunity Bio has leased a recently built US manufacturing facility from Athenex as part of an effort to expand its manufacturing capacity. The facility in Dunkirk, New York houses ISO Class 5 clean rooms for upstream and downstream manufacturing, as well as fill and finish and large-scale freeze-drying capabilities. Under the deal Immunity Bio will provide contract manufacturing capacity at the facility to Athenex. The lease agreement will see Immunity Bio pay Athenex $40 million according to reports in the…

February 21, 2022

eBook: Gene Therapies —
Developers Slowly Emerge from a Pandemic

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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,…

February 18, 2022

Cell and gene sector needs regulatory clarity says Andelyn

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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’s draft guidance on trialing multiple versions of a cell therapy and the EMA’s document on quality expectations for products containing genetically modified cells. While these efforts are a…

February 8, 2022