Biologics CMC Analytical Dev. Consultant

Challenge: A leading biologics company, dedicated to developing life-changing treatments for grievous blood disorders, faced an urgent need for a Biologics CMC Analytical Development Consultant. The client required a specialized expert to provide biologics analytical support, particularly in Mass Spectroscopy (LCMS), to advance their phase III biologics product through development and quality control (QC) activities.

Solution: Viltis swiftly assessed the client’s specific challenges and leveraged its extensive network to identify and deploy a highly experienced consultant with expertise in large molecule analytical development and LCMS assays. Viltis facilitated the consultant’s integration into the client’s team, ensuring alignment with the project’s scientific and operational goals.

The consultant, acting as a key advisor, introduced and implemented partnerships with new Contract Research Organizations (CROs). These strategic collaborations, orchestrated by Viltis, streamlined workflows and elevated the client’s capabilities. Additionally, the consultant worked across departments, ensuring cohesive scientific guidance in analytical development, quality, manufacturing, and regulatory affairs.

Results: With Viltis driving the solution, the client’s project gained critical support in LCMS-related activities, leading to enhanced operational efficiency and improved scientific collaboration. The consultant’s contributions enabled the phase III biologics product to meet critical development milestones while maintaining the highest regulatory and scientific standards.

Impact: Through Viltis' proactive problem-solving and expert deployment, the client was able to overcome resource and expertise challenges. The successful partnerships with CROs and streamlined processes significantly advanced the biologics product toward commercialization, bringing hope to patients living with grievous blood disorders.