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… Read More
DDW Editor Reece Armstrong speaks to Francisca Neethling, Head of Biotherapeutic Services and Olivier Mirguet, Global Head of Chemistry, … Read More
GSK will invest $30 billion (£22 billion) across the US over the next five years in research and development and supply chain infrastructure, the company has announced. The investment includes a new $1.2 billion (£880 million) investment in advanced manufacturing facilities and AI and advanced digital technologies,… Read More
Johnson & Johnson has revealed plans to increase its presence in North Carolina with a dedicated manufacturing facility at FUJIFILM’s new biopharmaceutical manufacturing site in Holly Springs, North Carolina. The $2 billion commitment to FUJIFILM over the next 10 years will expand the company’s US manufacturing capacity… Read More
The US Food and Drug Administration (FDA) has introduced FDA PreCheck, a new programme to facilitate the construction of manufacturing sites. More than half of pharmaceuticals distributed in the US are manufactured overseas and the US is reliant on overseas sources for active pharmaceutical ingredients (APIs). … Read More
The latest episode of the DDW Highlights podcast is now available to listen to below. DDW’s Megan Thomas narrates five key stories of the week to keep DDW subscribers up-to-date on the latest industry updates. Following the recent news that the FDA rejected Ultragenyx Pharmaceutical’s gene therapy due to manufacturing concerns,… Read More
News round-up for 21-25 July by DDW Senior Digital Content Editor Diana Turner. Following the recent news that the FDA rejected Ultragenyx Pharmaceutical’s gene therapy due to manufacturing concerns, manufacturing has dominated the headlines this week, particularly significant investment in facilities in the US, and new guidelines… Read More
The UK Medicines and Healthcare products Regulatory Agency (MHRA) has brought in new regulations designed to make it easier for personalised cancer treatments and gene therapies to be made where patients are treated. The new legislation ‘The Human Medicines (Amendment) (Modular Manufacture and Point of Care) Regulations… Read More
Biogen has announced that it intends to invest an additional $2 billion in its existing manufacturing footprint in North Carolina’s Research Triangle Park (RTP). The announcement comes at the same time as AstraZeneca also revealed plans to invest in its US facilities. Since breaking ground in 1995,… Read More
Cellular Origins, the Cell and Gene Therapy Catapult (CGT Catapult), and Resolution Therapeutics have formed a consortium to deliver a fully automated, scalable cell therapy manufacturing platform. The consortium has been awarded a cross-industry Smart Grant of £1 million from Innovate UK, the UK’s national innovation agency. Read More
The US Food and Drug Administration (FDA) has decided not to recommend Ultragenyx Pharmaceutical’s UX111 (ABO-102) AAV gene therapy as a treatment for patients with Sanfilippo syndrome type A (MPS IIIA). In its complete response letter (CRL), the FDA requested that the company provide additional information and… Read More
In this sponsored DDW Sitting Down With podcast we speak to experts from Lonza and Oxford Nanopore about their collaboration to bring direct mRNA sequencing (including N1-Methyl-pseudouridine) to a regulated environment and establish the new gold standard in sequencing technology. We discuss how nanopore sequencing will… Read More
A new sponsored DDW Sitting Down With podcast is now available. In this podcast, Megan Thomas speaks to experts from Lonza and Oxford Nanopore about their collaboration to bring direct mRNA sequencing (including N1-Methyl-pseudouridine) to a regulated environment and establish the new gold standard in sequencing technology. Read More
A new whitepaper is now available from Lonza Biologics entitled ‘A Comprehensive and Flexible Approach to CMC for Fab and Fc-Fusion Development Programs‘. Download the whitepaper to learn more about: Comprehensive CMC Solutions: Explore integrated Chemistry, Manufacturing, and Controls (CMC) strategies tailored to the unique challenges of Fab and… Read More
Download the whitepaper to learn more about: Comprehensive CMC Solutions: Explore integrated Chemistry, Manufacturing, and Controls (CMC) strategies tailored to the unique challenges of Fab and Fc-Fusion protein development. Overcoming Complexity: Learn how flexible approaches can streamline the development of complex protein formats, ensuring robust and scalable manufacturing processes. Accelerating Development… Read More
Chiesi Group has launched its Biotech Center of Excellence, dedicated to developing and producing monoclonal antibodies, enzymes, and other proteins, in Parma, Italy. From the production of drug substances from mammalian cells to their transformation into drug products and final packaging, the company says that everything… Read More
