Pharmaceutical Construction

The pharmaceutical industry continuously encounters challenges to discover, produce, and manufacture products to improve the overall health and well-being of the public. Each step in this progression is governed and scrutinized by agencies and regulatory requirements that will ultimately provide or deny product approval and dispensation. Accordingly, pharmaceutical facilities must be constructed with care and precision at the outset of the project.

During our many years of experience, our staff have gained an intimate understanding of the laws and regulations that accompany the construction of pharmaceutical facilities and environments in today’s life sciences industry. Our professionals provide services on programs and projects that involve clean rooms; laboratories; secondary manufacturing, packaging, and launch facilities; biological areas; etc. at a level of detail that corresponds to achieving owner-stated visions and goals by precise coordination of project schedules and tasks. We leave no project detail unattended when working with owners and stakeholders who are vested in providing these sensitive and complex environments.

Construction & Project Management Challenges

In this competitive landscape, flexibility and speed to market are just a few of the challenges we can help you overcome. Learn how MELL has helped deliver pharmaceutical projects.

GENERAL PHARMACEUTICAL INDUSTRY

MELL was engaged prior to project funding to provide third-party estimate reviews for all major capital projects in the United States, Puerto Rico, and in Mexico; project costs ranged between $5 million and $50 million. Facility construction types included research and QA/QC laboratories, chemical production, secondary manufacturing and packaging, and biological. Typical reviews included analyses of both high-level indicators as well as detailed metrics (e.g., hours, lf of pipe).

BIOPHARMACEUTICAL

MELL provided schedule and risk analyses assistance on a $50 million biopharma production facility. To meet the requirements of a systems turnover-based schedule so that commissioning, qualification, validation, and regulatory affairs teams could refine strategies, MELL assisted with the early development of the schedule for all qualification and process validation activities. Once the integrated schedule was complete, MELL performed schedule risk analyses, including a Monte Carlo simulation, to reflect the likelihood of the project achieving desired milestones. 

PHARMACEUTICAL & BIOTECH LABORATORIES

MELL was retained to analyze and determine the merits of more than ten claims, ranging in value from $15,000 to $10.9 million, submitted by construction service contractors on a new $60 million pharmaceutical laboratory and manufacturing facility. Claims involved work by multiple prime contractors, including piping, instrumentation, electrical, concrete, HVAC, and mechanical. This project is comprised of a laboratory building, pilot plant, administrative building, visitor center, warehouse, energy center, wastewater treatment plant, and several other buildings and associated infrastructure.

PRIMARY CHEMICAL

The project entails facility design and construction of a new production unit within an existing launch manufacturing facility. Total cost for the project was approximately $15 million with a total schedule of 22 months from the beginning of conceptual design through start-up of the facility. MELL provided project management controls and cost estimating services that involved the following:

• Ensuring that the project had correct cost and schedule controls in place early on

• Ensuring early cost estimates and schedules were well prepared, unbiased, complete, and comprehensive

SECONDARY MANUFACTURING

Per the request of senior management, MELL was asked to provide an independent review of two major secondary manufacturing projects, focusing on risks to the construction management project, validity of the latest cost forecast/estimate, and the schedule to complete.

Each review involved a detailed investigation at the project site and included interviews with key project team personnel and a review of relevant project documents. The MELL review team, focusing on areas of concern, performed detailed analyses of issues and risks to help develop an accurate status of the project.

Detailed analyses included the following:

• Review of the cost forecast for completeness, accuracy, up-to-date information, and methodology of projections
• Review of the schedule to ensure it was representing the project status, was accurate for predicting the path forward, and that sound practices were being followed
• Review of the change order status and system
• Assessment of contingency
• Assessment of risks, possible impacts to project cost and schedule, and potential mitigation steps
• Review of the organizational structure, roles, and responsibilities