Regulations

US Gov removes WuXi Bio site from Unverified List

A China-based subsidiary of CDMO WuXi Biologics can again receive certain imported bioprocess equipment after being removed from the US Government’s Unverified List (UVL). Back in February, the US Commerce Department included two subsidiaries of WuXi Biologics based in Shanghai and Wuxi – among 33 Chinese companies – to the list, restricting their ability to import certain items subject to the Export Administration Regulations (EAR) from the US. At the time, the contract development and manufacturing organization (CDMO) said the…

NJ plant woes continue for Lilly with reports of FDA 483

Eli Lilly has received an FDA Form 483 citing further manufacturing issues at its Branchburg, New Jersey facility, Reuters reports. The Reuters’ exclusive was based on a redacted copy of the Form 483 – obtained under a Freedom of Information Act request – which followed an inspection at the Branchburg facility by the US Food and Drug Administration (FDA) in July. Among the issues highlighted, Reuters said: “Lilly personnel found ‘unknown debris’ in a production area and that raw drug…

FDA creates advanced therapies ‘super office’ to meet higher demand

The US FDA office tasked with overseeing cell and gene therapies has been renamed and reorganized in response to increased submissions. The changes – details of which were published in the Federal Register last week – saw the ‘Office of Tissues and Advanced Therapies’ become the ‘Office of Therapeutic Products (OTP)’ and will be designated as a ‘super office’ that will manage its program at a macro level. The changes – which came into effect on September 16 – will…

Catalent hit with FDA 483 at Bloomington plant

A US FDA Form 483 has revealed visible foreign particles in certain batches of drug product at Catalent’s Bloomington, Indiana facility. The Bloomington plant, which offers fill and finish services and commercial scale production, was handed a Form 483 from the US Drug and Food Administration (FDA) following an inspection at the facility between August 1 and September 1. The 483 detailed that the FDA identified 179 occasions where particles, like black specks, foreign matter, particular matter, and foreign objects…

Bluebird Skysona approval: ‘A resurgence for HSC gene therapy’

The US approval of bluebird bio’s Skysona (eli-cel) marks a resurgence for the wider hematopoietic stem cell (HSC) gene therapy sector, says AVROBIO. Following the endorsement by an Advisory Committee in June, the US Food and Drug Administration (FDA) granted approval of bluebird bio’s Skysona (elivaldogene autotemcel, or eli-cel) Friday for the treatment of active cerebral adrenoleukodystrophy (CALD). Skysona uses ex vivo transduction with a Lenti-D lentiviral vector (LVV) to add functional copies of the ABCD1 gene into a patient’s…

Biden pledges $2bn to launch US biomanufacturing initiative

The US government will invest over $2 billion to launch its biomanufacturing initiative, which aims to expand manufacturing capacity in the country and ensure pandemic preparedness. The Executive Order was signed by President Biden on Monday and outlines the key goals of the biomanufacturing initiative. Overall, the Order looks to strengthen the country’s supply chain in the biopharma space and to reduce reliance on foreign manufacturing for the drug industry. Biden said it is the policy of his Administration to…

Cali court’s stem cell clinic ruling ‘flawed’ and ‘dangerous,’ says CGT advocacy group

The International Society for Cell & Gene Therapy (ISCT) has slammed the decision of a federal judge in California who ruled surgical procedure using a patients’ stem cells does not fall under the FDA’s regulatory jurisdiction. In 2017, the US Food and Drug Administration (FDA) took a series of actions “to remove unproven, potentially harmful treatment used in ‘stem cell’ centers targeting vulnerable patients.” This included the issuing of Form 483s and warning letters, the seizing of vials of materials…

Takeda and Cryoport team to standardize cell therapy supply chain

A standardized approach to collecting, processing, and storing cell therapy starting materials can reduce variations in manufacturing outcomes and simplify supply chain management, says Cryoport’s CEO. Temperature-controlled supply chain services firm Cryoport has partnered with Takeda’s plasma donation and collection business BioLife Plasma Services to offer standardized cell therapy collection, processing, and storage services for cell therapy products across the US and Europe. The collaboration, of which no financial details have been divulged, aims to establish an integrated GMP-compliant supply…

Iceland plant lands Alvotech’s Humira biosimilar CRL

Alvotech’s Humira biosimilar has suffered a setback after the US FDA noted deficiencies relating to its Reykjavik, Iceland manufacturing facility in a complete response letter (CRL). Alvotech filed AVT02 – a version of AbbVie’s bestselling monoclonal antibody (mAb) Humira (adalimumab) – last year but this week announced the US Food and Drug Administration (FDA) has rejected the initial biosimilar Biologics License Application (BLA), due to issues at its manufacturing plant. After visiting the facility in Reykjavik, Iceland in March 2022,…

Bluebird wins US approval for world’s most expensive drug, Zynteglo

Zynteglo’s $2.8 million price tag marks a new high, but bluebird bio says the one-time gene therapy works out cheaper than current beta-thalassemia treatment options. Following a positive Advisory Committee outcome in June, the US Food and Drug Administration (FDA) granted full approval for Zynteglo (betibeglogene autotemcel, or beti-cel) this week for the treatment of beta-thalassemia in adult and pediatric patients who require regular red blood cell (RBC) transfusions. The gene therapy, which was approved in Europe in 2019, is…