Scorpius shares: "Our clinical biomanufacturing services accelerate product development timelines from preclinical evaluation to first-in-human studies and beyond, in support of commercial manufacturing programs. By integrating bioassay and analytical method development, process development, cGMP manufacturing, and QC lot release testing, we efficiently assemble client-specific manufacturing solutions that enable a faster path to clinical trials and product commercialisation.
Analytical Methods Development
Scorpius employs a “phase-specific” approach to method development, qualification, and validation using key criteria (e.g., accuracy, linearity, precision, specificity, system suitability, etc.) to establish a baseline for subsequent qualification or validation studies.
• Drug Product Characterisation & QC Release Testing
• Protein Characterisation & QC Release Testing
• Plasmid DNA Characterisation & QC Release Testing
Regulatory Support
Scorpius works closely with clients to develop effective regulatory drug development strategies for advanced biological therapies from the early stages of product development to market authorisation.
• Evaluate and Guide Regulatory Strategy
• Represent Clients in Interactions with FDA or Other Regulatory Agencies
• Author and Review CMC Materials for Regulatory Applications & Submissions
• Leverage Experience with Global Regulatory Agencies Including FDA, EMA, PMD
Process Development
Our process development programs span all phases of product development and process optimisation. We can handle small-scale, preclinical evaluation and “proof-of-concept” studies to the development of cGMP-compliant, clinical-scale processes to commercial-scale process development."
• Creation of Master & Working Cell Banks
• Mammalian Cell Culture
• Microbial Fermentation
• Cell Therapy
• Upstream Optimisation
• Downstream Purification
