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Cytiva’s transcient cell line receives FDA AMT designation
The US Food and Drug Administration (FDA) has given an advanced manufacturing technology (AMT) designation to Cytiva’s transient cell line, making it one of the first gene therapy manufacturing technologies to receive the designation.
The ELEVECTA transient cell line for adeno-associated virus (AAV) manufacturing is said to reduce the formation and encapsidation of host cell DNA (hcDNA) by up to 99% compared to commercially available cell lines.
Residual hcDNA is a critical quality attribute in AAV manufacturing that requires careful monitoring and control. Non-therapeutic DNA fragments, particularly those encapsidated within viral particles, represent a process‑related impurity that can impact product consistency and purity. However, once hcDNA is packaged inside the capsid, it cannot be effectively removed through downstream purification, making it a persistent challenge.
The FDA’s AMT designation recognises drug manufacturing technologies that elevate the reliability, quality, and robustness of advanced therapeutics manufacturing.
By enabling a streamlined Chemistry, Manufacturing, and Controls (CMC) review and frequent communication with the FDA, the AMT designation can help accelerate manufacturing-related development timelines and create a meaningful advantage through faster time to market.
“The FDA’s AMT designation for the ELEVECTA transient cell line gives our customers a clearer and more predictable path to adopting advanced AAV manufacturing technologies,” Emmanuel Abate, President of Genomic Medicine at Cytiva.
“The platform is designed to support a strong product quality profile, including significantly reduced levels of encapsidated host cell DNA. This establishes a clear path for AAV therapy development, helping teams mitigate risk and progress programmes with greater confidence.”
The post Cytiva’s transcient cell line receives FDA AMT designation appeared first on Drug Discovery World (DDW).
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STAT+: Up and down the ladder: The latest comings and goings
Hired someone new and exciting? Promoted a rising star? Finally solved that hard-to-fill spot? Share the news with us, and we’ll share it with others. That’s right. Send us your changes, and we’ll find a home for them. Don’t be shy. Everyone wants to know who is coming and going.
And here is our regular feature in which we highlight a different person each week. This time around, we note that AstronauTx hired Michelle Mellion as chief medical officer. Previously, she held the same role at PepGen and EveryONE Medicines.
But all work and no play can make for a dull chief medical officer.
Hired someone new and exciting? Promoted a rising star? Finally solved that hard-to-fill spot? Share the news with us, and we’ll share it with others. That’s right. Send us your changes, and we’ll find a home for them. Don’t be shy. Everyone wants to know who is coming and going.
And here is our regular feature in which we highlight a different person each week. This time around, we note that AstronauTx hired Michelle Mellion as chief medical officer. Previously, she held the same role at PepGen and EveryONE Medicines.
But all work and no play can make for a dull chief medical officer.
Officials sanctioned Dabur India months after FDA inspectors found bird droppings and data integrity deficiencies during an inspection of the plant.
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STAT+: Pharmalittle: We’re reading about a discontinued cancer drug, a Novo security breach, and more
And so, another working week will soon draw to a close. Not a moment too soon, yes? This is, you may recall, our treasured signal to daydream about weekend plans. Our agenda includes promenading with the official mascots, catching another round of live musical vibes here and there, and taking pride in some folks who are dear to us. We also hope to hold yet another listening party, where the rotation will likely include this, this, this, this and this. And what about you? This is a wonderful time of year to sample the many outdoor activities popping up — street fairs, festivals, and all sorts of gatherings can be sampled. If the weather fails to cooperate, though, you could curl up with a good book, sit in front of the telly to take in one or more sporting events, or plan a needed getaway. If none of this strikes your fancy, you could simply park yourself somewhere comfortable for a while and remain zen. Well, whatever you do, have a grand time. But be safe. Enjoy, and see you soon. …
In a rare move, the nonprofit organization Blood Cancer United announced it was buying the remaining supplies of Luvelta, a discontinued investigational cancer drug, STAT reports. As part of the transaction, Blood Cancer United, previously known as the Leukemia & Lymphoma Society, also will acquire the investigational new drug designation and manage the compassionate-use program for children with a rare form of blood cancer, distributing the medication to patients at no cost while supplies last. Sutro Biopharma discontinued development in March 2025 and also eliminated a compassionate use program.
Novo Nordisk identified a security incident in which certain information, including patient data from some clinical trials, was copied externally without authorization from its internal IT systems, Reuters notes. The company said it launched a probe with the assistance of external cybersecurity experts and is in contact with the relevant authorities. The potential categories of personal data affected may include patient ID, year of birth, sex, and health or immunogenicity data among others. Novo did not provide further details, but does not believe the incident will enable any third party to identify participants in its clinical trials.
And so, another working week will soon draw to a close. Not a moment too soon, yes? This is, you may recall, our treasured signal to daydream about weekend plans. Our agenda includes promenading with the official mascots, catching another round of live musical vibes here and there, and taking pride in some folks who are dear to us. We also hope to hold yet another listening party, where the rotation will likely include this, this, this, this and this. And what about you? This is a wonderful time of year to sample the many outdoor activities popping up — street fairs, festivals, and all sorts of gatherings can be sampled. If the weather fails to cooperate, though, you could curl up with a good book, sit in front of the telly to take in one or more sporting events, or plan a needed getaway. If none of this strikes your fancy, you could simply park yourself somewhere comfortable for a while and remain zen. Well, whatever you do, have a grand time. But be safe. Enjoy, and see you soon. …
In a rare move, the nonprofit organization Blood Cancer United announced it was buying the remaining supplies of Luvelta, a discontinued investigational cancer drug, STAT reports. As part of the transaction, Blood Cancer United, previously known as the Leukemia & Lymphoma Society, also will acquire the investigational new drug designation and manage the compassionate-use program for children with a rare form of blood cancer, distributing the medication to patients at no cost while supplies last. Sutro Biopharma discontinued development in March 2025 and also eliminated a compassionate use program.
Novo Nordisk identified a security incident in which certain information, including patient data from some clinical trials, was copied externally without authorization from its internal IT systems, Reuters notes. The company said it launched a probe with the assistance of external cybersecurity experts and is in contact with the relevant authorities. The potential categories of personal data affected may include patient ID, year of birth, sex, and health or immunogenicity data among others. Novo did not provide further details, but does not believe the incident will enable any third party to identify participants in its clinical trials.
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