Therapeutic Class

GE and Germfree in modular gene therapy manufacturing collaboration

GE Healthcare has teamed with cleanroom production firm Germfree to develop a modular biomanufacturing facility for emerging biotherapeutics and gene therapies. Bioprocess vendor GE Healthcare is no stranger to modular manufacturing platforms, with the likes of Bayer, Pfizer and Lonza all opting for its off-the-shelf KUBio platform modular biologics factory. Furthermore, to date 63 manufacturers have selected the firm’s FlexFactory bioprocess platform, which uses predominantly single-use technology. And now the company has partnered with Florida-based Germfree to co-develop a new…

CGT CMC: Plan ahead, avoid comparability studies says Novartis

Making changes to the manufacturing process for cell and gene therapies is possible but cumbersome due to the need to perform comparability studies, says a Novartis veteran. Speaking at the Cell & Gene Therapy Bioprocessing & Commercialization conference – part of Biotech Week Boston – this week, Novartis’ Sergio Fracchia advised developers of advanced therapies to think about their manufacturing needs several years in advance to avoid future pitfalls. Specifically, Fracchia – who serves as Global regCMC Director, Cell and…

Scancell adds first partner for high potent MAb tech

Immuno-oncology firm Scancell has begun offering its AvidiMab technology to partners looking to increase the potency of their monoclonal antibody pipelines. Scancell has its own pipeline of monoclonal antibodies (MAbs) targeting novel cancer treatments, but this deal represents the first collaboration with an external partnerover its AvidiMab technology. “AvidiMab is proprietary technology to enable the modification of the constant region (FC) of a human antibody to allow direct tumor killing of antibodies directed to tumor associated antigens (TaGs) but may…

FDA warns another unapproved cell therapy firm

The US FDA has slammed a self-described regenerative cellular therapy manufacturer for selling unapproved umbilical cord blood and umbilical cord products. California-based Stemell describes itself as an “organization dedicated to leadership, education, service, research and manufacturing of regenerative cellular and cell-free products,” making products StemL UCB-Plus and StemL UCT-Plus, derived from human umbilical cord blood and umbilical cord, for allogeneic use. However, in the latest example of a crackdown on unapproved stem cell therapies the firm has been at the…

Vertex looks to stem cell islets for diabetes in $950m ‘toolbox’ deal

Vertex has acquired Semma Therapeutics adding a program using pluripotent stem cell-derived islets as a potentially treatment for type 1 diabetes. While Semma is yet to have brought a therapy into the clinic, the Massachusetts-based firm has created a process it claims can produce stem cell-derived islets (SC-islets) starting from human pluripotent stem cells capable of developing into any cell type in the body. Its lead candidate has completed preclinical proof-of-concept studies demonstrating evidence of the potential of such technology…

Celyad going to clinic with tweaked CAR-T manufacturing platform

Celyad expects to treat the first patients with its autologous CAR-T therapy CYAD-01 using the updated manufacturing process by the end of September. CYAD-01 is an autologous chimeric antigen receptor (CAR) T-cell therapy in development by Celyad for hematological malignancies and solid tumors. The immunotherapy has the ability to bind to eight different ligands that are naturally expressed by cancer cells. In July, the firm announced regulators accepted a proposal to change the candidate’s manufacturing process to use its proprietary…

Lineage granted stem cell production patent for cancer vax

The patent validates a system for production of antigen presenting dendritic cells from human embryonic stem cells (hESCs), used in Lineage Cell Therapeutics’ cancer immunotherapy program VAC2. The United States Patent and Trademark Office (USPTO) issued Patent No. 10,344,262, entitled ‘Differentiation of primate pluripotent stem cells to hematopoietic lineage cells,’ to Lineage Cell Therapeutics in July. The patent was filed by Asterias Biotherapeutics in February 2017. Asterias was acquired by clinical-stage biotech BioTime in March 2019, and since then BioTime…

Why freezing should be a hot topic for cell therapy sector

Cell therapy firms need to think about freezing earlier in process development according to an expert, who says optimized cryopreservation is key. Cell therapies have the potential to revolutionize medicine. For example, products like Yescarta and Kymriah can treat cancers more effectively and with fewer side effects than even the best chemotherapies. But unlike chemotherapies, cell therapies are highly susceptible to the temperature fluctuations that occur during transportation. To address this, developers protect their products using various methods, with cryopreservation…

Moderna talks vaccines, from mRNA to Zika

Moderna, Inc has received US FDA Fast Track designation for its investigational Zika vaccine based on its messenger RNA (mRNA) technology. The US Food and Drug Administration (FDA) has been granted to mRNA-1893, a vaccine intended to treat Zika currently in Phase I clinical studies. The Fast Track designation is designed to speed up development and review of therapies and vaccines needed to fill an unmet medical need. “Our Zika program is part of Moderna’s broader commitment to improving global…

US Gov provides Merck extra $23m for Ebola vaccine

The Health and Human Services (HHS) funding will support continued development of V920, a live viral vectored vaccine designed to protect against Zaire Ebola virus, says Merck. Merck & Co. began developing a vaccine to protect against the Ebola virus following the 2014-2016 Ebola outbreak in West Africa. In 2017, the firm received a definitive contract funded by the Office of the Assistant Secretary for Preparedness and Response of the HHS, originally worth $126 million (€114 million), to aid development…