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.
Teva says it has increased the lifespan of its Protein A resin and thus reduced the cost of manufacturing monoclonal antibodies by tweaking its cleaning materials.
Repligen’s customer GE Healthcare opted to make its latest Protein A ligand in-house, but CEO Tony Hunt remains confident in his firm’s long-term partnerships and diversified bioprocessing offering.
GE Healthcare has launched a Protein A resin it says can improve monoclonal antibody purification capacity by up to 40% compared to its current offering.
Catalent has cited Cook’s ability to make and freeze-dry liquid drugs as major drivers for its planned takeover and said it is keen to take on the firm’s biopharma customers.
Kiadis Pharma says it is looking at expanding production of its blood cancer cell therapy candidate ATIR101 after receiving US FDA breakthrough designation.
