AMP

Biomanufacturing for others, namely, manufacturing of pharmaceuticals using biological organism in the manufacturing process; custom manufacture for others of products relating to biotechnology, namely, recombinant proteins for use in the biotechnology industries; custom manufacture for others of cell therapy products; custom manufacture for others of gene therapy products; custom manufacture of pharmaceuticals in accordance with specific standards GMP regulations

Contract development and manufacturing organization (CDMO) services, namely, pharmaceutical drug development services; consulting and advisory services in the field of analytical development and quality control testing of pharmaceutical, gene therapy, and cell therapy products; consulting and advisory services in the field of manufacturing process development for pharmaceutical, gene therapy and cell therapy products; consulting in the field of chemistry manufacturing and controls (CMC) activities; testing of pharmaceutical, gene therapy, and cell therapy products and materials; quality control testing of pharmaceutical products and materials, namely, biopharmaceutical products and materials in accordance with specifications or requirements of regulatory standards applicable in target countries; testing and validation services of biopharmaceutical products to assure compliance with global regulatory requirements, specifications, and industry standards for pharmaceutical, cell therapy and gene therapy methods of development; technical consulting for regulatory compliance in the field of chemistry manufacturing and controls (CMC)