News & Analysis on the Clinical Development and Manufacture of Large Molecule Drugs
Rani Therapeutics, a clinical-stage biotherapeutics company focused on the oral delivery of biologics, has announced encouraging results from its phase 1 study of RT-111, a RaniPill capsule containing an ustekinumab biosimilar, CT-P43.
In late 2023, Vertex Pharmaceuticals and CRISPR Therapeutics made history by gaining the first FDA approval for a CRISPR-based drug, exagamglogene autotemcel (Casgevy) for the treatment of sickle cell disease with vaso-occlusive crisis.
Ion exchange resin manufacturer Purolite and bioprocessing technology firm Repligen have announced the commercial launch of Praesto CH1, an affinity resin designed to purify specialized mAbs such as bispecifics and recombinant antibody fragments.