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Pharmaceutical & Biotechnology


Mayne Pharmaceuticals, Oral Solid Dosages, Greenville, NC Mayne Pharmaceuticals, Oral Solid Dosages, Greenville, NC Mayne Pharmaceuticals, Oral Solid Dosages, Greenville, NC Mayne Pharmaceuticals, Oral Solid Dosages, Greenville, NC

Mayne Pharmaceuticals, Oral Solid Dosages, Greenville, NC


Mayne Pharmaceuticals is a specialty company with a 30-year track record in developing both non and high potent oral solid dose (OSD) pharmaceuticals. Mayne is expanding their site in Greenville, NC from the existing research and development facility to a new 126,000 SF OSD commercial manufacturing facility, adjacent to the existing facility. Middough is working closely as a partner with Mayne Pharmaceuticals on the development of the master site plan, conceptual design, preliminary engineering and the detailed design.

Middough is the architect and engineer of record for this project. The services we provided include engineering/design, procurement assistance of major equipment, assisting in the selection of the construction management firm, and construction support.

International Centre for Infectious Diseases (ICID), HIV Clinical Vaccine Facility, Winnipeg, Canada

International Centre for Infectious Diseases (ICID), HIV Clinical Vaccine Facility, Winnipeg, Canada


Middough provided preliminary engineering services for the International Centre for Infectious Diseases (ICID) 130,000 SF, $88 million, cGMP clinical production facility for HIV / AIDS vaccines, located in Winnipeg, Manitoba. This integrated facility is designed to support and accelerate process development and clinical trials for a large number of highly promising candidate vaccines, following laboratory-based discovery and screening. Middough's scope of services included process architecture layouts, process flow diagrams, equipment selection and a cost estimate. Process operations included microbial fermentation, cell culture with viral vectors and egg-based recombinant technologies, as well as separation and purification and aseptic filling. The facility is designed to BSL-3/2 criteria.
Aeras Global TB Vaccine Foundation, Cell Culture Suite and Powder Vaccine Facility, Rockville, MD Aeras Global TB Vaccine Foundation, Cell Culture Suite and Powder Vaccine Facility, Rockville, MD Aeras Global TB Vaccine Foundation, Cell Culture Suite and Powder Vaccine Facility, Rockville, MD Aeras Global TB Vaccine Foundation, Cell Culture Suite and Powder Vaccine Facility, Rockville, MD

Aeras Global TB Vaccine Foundation, Cell Culture Suite and Powder Vaccine Facility, Rockville, MD


Middough has managed a number of assignments for the Aeras Global TB Vaccine Foundation including the design of a new cell culture suite and a Powder Vaccine Clinical Launch Facility. The cell culture and harvest suite is an expansion of existing clean manufacturing space, located adjacent to protein purification. The new BSL-2 facility will utilize both stainless steel and disposable 300L cell culture bioreactors and harvesting equipment including a continuous centrifuge. Seed and media preparation space is also included within the suite. The Powder Vaccine Facility will support new products in development by Aeras. The process utilizes spray drying technology and is designed to produce five million doses of vaccine packaged for clinical trials and subsequent product launch. The 25,000 SF facility will be designed to be LEED® certified.
Confidential Client, Bio-Therapeutics Production Site, Midwest

Confidential Client, Bio-Therapeutics Production Site, Midwest


Middough was selected to perform preliminary and detailed engineering for the fit-out of an additional multilevel production suite to expand the production capacity of their bio-therapeutic products. Our scope included development of the documents necessary to construct and install all required equipment, piping, instrumentation and facility modifications. The project included new tanks, a new filtration system, a new CIP skid and the associated sterile piping systems. Additional services included cost estimating, scheduling and construction phase support and construction management.
Confidential Client, API Manufacturing, Midwest

Confidential Client, API Manufacturing, Midwest


A leading pharmaceutical CMO engaged the services of Middough on a project to increase the production of a human therapeutic Active Pharmaceutical Ingredient (API). The project involves the installation of new equipment and rework of the existing production train to change the process flow and increase the current production capacity as well as automate the process to increase reliability. In general, each processing vessel will be equipped with a solvent header that will supply specific solvents needed for that vessel. The solvent header will be supplied with instrumentation and actuated valves necessary so that the batch recipe will be able to charge a specified quantity of appropriate solvent when required. Middough is providing full EPCM services.
Confidential Client, Site Optimization Program, Midwest

Confidential Client, Site Optimization Program, Midwest


As part of their strategic plan, a leading pharmaceutical company engaged the services of Middough to evaluate facility and utility relocation options, and related detailed design documents, to support their new vision for one of their manufacturing / R&D locations.  Work included:
  • High voltage electrical design for relocation of substations and feeders
  • Piping design for relocation of plant and process utilities
  • Structural design for building modifications and pipe-racks
  • Civil design including modification of roadways and underground utilities as well as site grading and drainage designs
  • Architectural design of new and modified buildings
  • Specification of utility equipment including new air compressors
  • Development of the project total install cost estimate
  • Construction support and administration

Middough’s scope includes a full range of architectural and engineering services, including drawings
and specifications, engineering services during construction and scheduling of design activities and
cost estimating of the total project cost.
 
Valent, BioSciences, Osage, IA Valent, BioSciences, Osage, IA Valent, BioSciences, Osage, IA Valent, BioSciences, Osage, IA

Valent, BioSciences, Osage, IA


This new 95-acre greenfield Industrial Fermentation campus utilizes a large scale microbial process to produce “green” biorational chemicals that are recovered and purified for use as pesticides and plant growth regulators.

The design of this facility includes a 120,000 SF production space, a 30,000 SF laboratory / administration building, and a 30,000 SF central utilities building.

Throughout this 29-month project, Middough provided planning, engineering, scheduling, procurement and estimating services. State-of-the-art software tools including Bentley Smart P&ID, Bentley 3-D AutoPlant and REVIT were utilized during the development of the design.
Major Multi-National Pharmaceutical Company, Florence, SC

Major Multi-National Pharmaceutical Company, Florence, SC


Middough has completed a series of chiller replacements for this major multi-national pharmaceutical company. They were designed to optimize the use of energy and reduce the use of halogenated hydrocarbons in plant operations. The chiller demand profile was determined and alternate designs were studied to best match the system response and efficiency to the various loads. The final design incorporated multiple parallel chillers with variable frequency drives, controlled by a supervisory controller that follows a user adjustable algorithm to optimize energy usage. Ammonia was chosen as the refrigerant as it is a natural refrigerant with no impact to the environment. Safety and odor control are assured through the use of multiple refrigerant detectors, an emergency ventilation system and vent scrubber.
Confidential Client, Program Management, Midwest

Confidential Client, Program Management, Midwest


Middough was selected by an animal health company to perform program management for a portfolio of projects at one of their production sites. The facility produces fermentation derived antibiotics and enhanced animal feeds.  Services included program management, project management, construction management, scheduling, estimating, engineering and architecture. The overall intent of the program is to implement a variety of process, utility and facility enhancements over a two-year period.