Novartis is working with the US FDA to solve a manufacturing issue affecting Kymriah, identified as ‘variability in its commercial specifications’, says CEO.
Novasep has launched a downstream processing tool that combines batch and continuous chromatography for monoclonal antibodies, recombinant proteins and blood factors.
Ultragenyx Pharmaceutical is transferring fill/finish activities for Mepsevvi from Rentschler Biopharma’s facility in Germany, to Rentschler Fill Solutions in Austria.
Academic research underpins many of the early success stories in continuous manufacturing. Now, Blair Brettmann and her team are working to write another chapter by applying electrospinning and other techniques to downstream processing.
AstraZeneca says the build-up of biologics manufacturing capacity at its yet-to-launch facility in Sweden has contributed to a reduced core gross margin this quarter.
Novasep is investing €10m ($11.88) in a commercial fill/finish facility for viral vectors, mAbs, and other low-volume biologics, as part of its plan to double in size by 2022.
GE Healthcare Life Sciences has launched an updated, flexible cell processing system designed to rapidly and effectively harvest cells for treatments, including CAR T-cell therapy.
Process control, quality management and training operators are areas where biomanufacturers can learn from small molecule makers, according to preliminary results from a BioPlan Associates survey.
The US Patent and Trademark Office has granted a notice of allowance for ‘shelf life’ timer technology used to protect time-sensitive biologic materials in transit.
BIA Separations has teamed with Nuvonis Technologies to help vaccine and cell therapy developers tackle the transition from upstream to downstream processing.
Vetter is talking with customers to create a “stable financial plan” that will justify the manufacturer’s previously announced $320m investment for a new facility, which is not expected to break ground before 2022.
The CDMO says it is building a 150,000 square-foot biomanufacturing facility in Maryland in preparation for a double-digit growth in the gene therapy space.
Cellular Biomedicine Group Inc (CBMG) has selected GE Healthcare’s FlexFactory technology for its CAR-T therapy production facility in Shanghai, China.
Venture capital company Dynamk Capital has invested in FloDesign Sonics citing its acoustic wave separation technology’s application in the growing CAR T cell sector.
TxCell SA has developed the production process for it range of CAR-Treg based therapies and is preparing to transfer it to its CMO ahead of first-in-human trials.
Eli Lilly has projected an increased spend across its biomanufacturing network next year to support bulk production and fill/finish of monoclonal antibodies.
CAR T developers must be involved throughout the entire supply chain says Kite Pharma, which depends on accreditation and training programmes across its network of Yescarta administration clinics.
The EMA has accepted to review Mylan’s trastuzumab and pegfilgrastim biosimilars amid remediation efforts at biomanufacturing partner Biocon’s fill and finish plant in India.
Pall Corporation has launched a monoclonal antibody clarification platform without centrifugation or process additives to support cell cultures of up to 2,000L.
Antibody-drug conjugate (ADC) developers are at risk of aggregation issues caused by the hydrophobic nature of next-generation linker-payloads, says ADC Bio.
