As advanced therapies move from development towards commercial scale, quality is becoming far more than a regulatory checkpoint. It is increasingly a strategic discipline that must be embedded across product development, manufacturing, technology t... Read more
As cell and gene therapies progress towards broader commercialisation, scientific innovation alone is no longer enough. The next generation of therapies must be designed from the outset with potency, manufacturability, scalability, analytical robus... Read more
For emerging biopharma companies, speed, quality and scalability cannot be treated as separate priorities. As products progress towards commercialisation, decisions around process design, raw materials, manufacturing capacity, reg... Read more
As biologics and novel modalities become increasingly sophisticated, understanding molecular structure under controlled conditions tells only part of the story. The emerging analytical challenge is to connect molecular structure and cellular phenot... Read more
HCW Biologics Inc. (the “Company” or “HCW Biologics”), a U.S.-based clinical-stage biopharmaceutical company focused on developing novel fusion immunotherapeutics to treat autoimmune diseases, cancer, and senescence-associat... Read more
Eisai Co., Ltd. and Biogen Inc., announced that once weekly lecanemab-irmb subcutaneous injection (brand name: LEQEMBI IQLIK®) is now available in the U.S. for initiation therapy for early Alzheimer’s disease (AD) in adults with mild cogn... Read more
As cell and gene therapies progress towards broader commercialisation, scientific innovation alone is no longer enough. The next generation of therapies must be designed from the outset with potency, manufacturability, scalability, analytical robus... Read more
Lonza will build a new large-scale, commercial PSD-4 spray-drying facility in Bend, Oregon (US) to support a rapidly expanding market segment The investment will reinforce the Bend site as a center of excellence for particle engineering ... Read more
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