A client decided to outsource a Phase 2 study of a monoclonal antibody. The scope of the work included developing and validating
methods for stability, characterization, and release, including reverse-phase HPLC, size-exclusion HPLC, SDS-PAGE, ELISA,
isoelectric focusing, Karl Fisher (moisture), and mass spectrometry (Q-ToF) for mass and sequence. Release and stability testing
of clinical batches of drug product were to follow.
The timelines for the study were tight because the decision to outsource was made rather late. In order to meet the timelines,
the contract laboratory had to assemble an experienced project team to initiate parallel method development efforts. The timing
was less than ideal: not only was the contract laboratory given only two weeks lead-time, but it was already working at capacity.
The division director gathered his management team to discuss resource strategy and how to ensure that the contract laboratory
did not over-promise and under-deliver. The group recognized that they needed a skilled project manager and identified one
of the project management tools and approaches discussed previously.
As a proactive measure, several discussions occurred between the contract laboratory and the client before committing to the
study to ensure that the technical information provided was clear and the scope of work was well understood. Next, the project
manager prepared a draft detailed timeline of the project activities with the client-desired completion date as the end goal.
Based on this, the number of resources was estimated and scheduled. The plan was provided to the client and approved with
some minor modifications.
The strategy was to begin with two to three analysts and then ramp up when additional resources became available. Because
assembling a project team composed solely of experienced staff was not possible, an experienced technical manager was assigned
to oversee the development efforts and design all studies. The team identified potential risks and the project manager and
technical lead devised a risk mitigation plan. Before initiating the laboratory work, they conducted project initiation meetings,
both with the client and internal team members. This included members of the dedicated quality assurance audit, and technical
writing teams. Throughout the study, the project manager held weekly conference calls to keep both parties informed and engaged
in technical issues. Calls covered status of all project tasks, timeline shifts, and budget adjustments. The project manager
communicated any critical issue that needed input from the client. These issues were effectively resolved with interactive
discussions. Upper management from both parties became involved only when budget adjustments needed approval.
The contract laboratory completed development and validation studies for all of the methods in just slightly over one week
longer than the original timeline. The budget for method development was adjusted once to slightly increase the "cap" to account
for additional development time for the Q-ToF method.
The client was pleased with the management of the project, overall performance of the team, level of communication, and responsiveness
of the contract laboratory. As a result, the client has decided to award the contract laboratory another similar program for
a second compound in Phase 1.
Magdalena R. Mejillano is the vice president of operations, cGMP laboratory PPD, Inc., 608.203.4027, Magdalena.Mejillano@madison.ppdi.com
Chris Lively is director, biopharmaceutical testing; Stacey Sullivan is director, business development.