Case study

Biologics CMC PIP

CMC and quality oversight for a Phase III monoclonal antibody program at a CMO.

Discuss a similar engagement

IndustryLife sciences

Practice areaConsulting & resourcing

EngagementDelivery team support

FocusProgram execution

Challenge

Define the operational need

Response

Mobilize the right expertise

Delivery

Integrate and execute

Outcome

Restore program momentum

Challenge

The situation that required specialized support.

A therapeutics company in a Phase III clinical trial needed a CMC and quality specialist to oversee Contract Manufacturing Organization operations. The work called for cGMP upstream and downstream drug substance manufacturing experience on a monoclonal antibody, plus process characterization studies and BLA preparation.

Approach

How Viltis responded

Viltis placed a local consultant onsite in Saint Louis, MO, with cGMP manufacturing and quality oversight experience. That kept the working relationship with the CMO direct rather than mediated through the client.

01
Assessment
Clarify technical, quality, and timeline requirements for the engagement.
02
Planning
Define roles, sequencing, and integration with the client organization.
03
Execution
Deploy specialists and maintain coordinated progress against milestones.
04
Handover
Support operational continuity as the program returns to steady-state ownership.

Impact

What the engagement delivered

The client got proper oversight of cGMP production and completed its process characterization studies. The consultant also moved BLA preparedness forward, which mattered for holding the clinical trial timeline.

The engagement covered a demanding phase of the monoclonal antibody program without the client having to pull its own staff off other work to do it.

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