CNCT19, an autologous, gene-edited chimeric antigen receptor T-cell therapy by CASI Pharmaceuticals and Juventas Cell Therapy for the treatment of relapsed or refractory acute lymphoblastic leukemia, was granted orphan drug designation by the FDA. CNCT19 targets the CD19 protein on cancer cells' surfaces.
Center for Breakthrough Medicines will gain commercial rights to certain gene therapy manufacturing and analytics technology in a five-year collaboration with the University of Pennsylvania to help biotechnology companies and universities develop gene therapies.
The market is growing for small-batch biopharmaceutical products such as complex bispecific antibodies and rare disease therapies, and modern perfusion processes and small bioreactors might offer cost advantages and geographic flexibility, says Trent Munro of the University of Queensland's National Biologics Facility. "Rather than automatically defaulting to a large-scale fed-batch commercial process, we will see molecules being developed with a fit-for-purpose strategy, in terms of both scale and process," Munro said.
Pharmaceutical supplies such as glass vials were reprioritized in response to the COVID-19 pandemic, and biopharmaceutical manufacturers must try to predict supply needs accurately, maintain inventory and prequalify alternative sources, says Genezen founder Bill Vincent. A focus on sustainability, the rise of novel therapeutics and technologies, demand for speed, a shortage of skilled labor and precision medicine will also present challenges for manufacturers this year, industry leaders say.
UK-based Ori Biotech will build out its quality system, supply chain and manufacturing capacity and hire additional personnel after raising more than $100 million in a Series B financing round, CEO Jason Foster says. The company is automating, digitizing and standardizing the cell and gene therapy manufacturing process, starting at the preclinical stage, to increase throughput, improve quality and reduce costs.
Scientists at the University of Massachusetts Lowell received a one-year, $930,223 grant from the National Institute for Innovation in Manufacturing Biopharmaceuticals to support development of a process to freeze dry messenger RNA vaccines. Lyophilization would enable room-temperature storage and extend shelf life, facilitating the use of mRNA COVID-19 vaccines where cold storage is a challenge and enabling the establishment of stockpiles.
An influx of newer and younger laboratorians are entering leadership roles as more experienced clinical laboratory professionals leave the profession or retire. This article highlights the challenges facing the new generation of laboratory leaders, as well as the need for more leadership training to be included in curricula and the importance of engaging with professional societies to prepare for these roles.
Laboratorians, in collaboration with providers, can help optimize the laboratory test menu to guide ordering patterns and ensure that patients receive the right tests, writes Charlene Bierl, MD, director of the division of laboratory medicine in the department of pathology and laboratory medicine at the Hospital of the University of Pennsylvania. Laboratorians should regularly check the choices given to providers and understand the organization so they can guide utilization when needed, she adds.
The FDA announced Wednesday that all blood specimen collection tubes will now be included in an expanded medical device shortage list due to supply shortages caused by increased demand during the pandemic, as well as vendor issues. Lab and health care personnel have been advised to minimize blood collection tube use by performing only medically necessary blood draws and to consider sample sharing between lab departments for available specimens.
Researchers said that the protein alpha-synuclein, which has been associated with the pathogenesis of Parkinson's disease, plays a critical role in helping the body's immune response fight against infection, according to a study found in Cell Reports. "Alarmins are endogenous proteins that both alert and direct the immune system to effectively tackle an infectious insult. [Alpha-synuclein] appears to be an alarmin," said Joost Oppenheim, one of the researchers.
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