The U.S. biopharmaceutical industry stands out as a leading research and development (R&D) and advanced manufacturing industry, resulting in a total economic impact of over $1 trillion. The record of significant innovation and growth in the biopharmaceutical industry is expected to continue unabated into the indefinite future. As technology and processes advance within the industry, so too will the complexity of the cGxP requirements governing the safety and efficacy of the innovative therapies produced.
Successful companies within the industry will be those who translate their innovation through effective implementation of capital to bring their therapies to the market.
Pharmaceutical/BioTech Engineering and Design
Biopharmaceutical clients choose Middough because we provide the broad technical expertise, project management and construction management capabilities of a global, mega- EPC firm, while still ensuring a high degree of collaboration and customer service you would more commonly expect from “boutique” firms.
Middough ensures our biopharmaceutical clients’ success on every project through the application of Middough Advanced Project Procedures (MAPP™ which ensures the consistent quality of communication, collaboration, and deliverables).
Pharma-Bio Tech Industry Leadership
Middough’s biopharmaceutical SMEs provide you the engineering, architecture, and project management leadership developed through decades of experience and a proven track record for successfully implementing cGxP projects from the laboratory to validated full-scale production. Middough understands how to effectively work with your cross-functional team to meet the critical functional, regulatory, and commercial objectives of your business from Pharmaceutical Facility Design, equipment design, and other engineering needs.
Active Pharmaceutical Ingredients
The Active Pharmaceutical Ingredient sector of the Pharmaceutical and Biotechnology industry faces challenges of a constantly changing market, regulations, and technology, in addition to the impact of the pandemic. Clients choose Middough for the technical expertise and track record in understanding these regulations and important projects related to chemical synthesis, the microbial and enzymatic processes, and plasma fractionation that impact API manufacturing.
Drug product manufacturers are constantly looking to streamline approaches to tackle the issues they face with supply chain and competition. Clients in the drug product manufacturing sector of the pharma-biotech industry work with Middough because of our experience in delivering projects to maximize full scale production including aseptic processing, lyophilization and other unit operations.
Regulations and cost of development are two key issues for medical device manufacturers. Middough’s effectiveness as a team, including understanding how to meet critical regulatory and commercial objectives for manufacturing devices, helps clients work through these unknowns.
Assembly and Packaging
Middough and our teammates impact the assembly and packaging sector of the pharmaceuticals industry in several areas utilizing services, tools and technology for clients looking to enhance sustainability efforts, flexibility in production as well as their supply chain and storage in the form of facilities and equipment.
Sterilization of medical equipment has become an even larger key component for the pharma-biotech industry. Middough’s familiarity and expertise with regulations and GMP helps clients continue to implement and use reliable sterilization methods.
Current Good Manufacturing Practices (cGMP)and Current Good Laboratory Practices (cGLP) ensure that laboratories, clean rooms and manufacturing suites, vivaria, and warehouses follow controlled manufacturing processes with proper design and monitoring. Middough’s experience and knowledge of cGMP and cGLP facilities, labs and clean rooms allow us to design facility layouts for control, air change range, pressurization, temperature control, passthroughs and more to meet regulations.
Engineering and design support for utilities is critical to the processes performed in pharmaceutical and biotech labs. Middough’s expertise in HVAC for controlled environments, water for several uses including water for injection (WFI), clean steam for sterilization and facility power ensures reliable performance. Middough keeps these processes running safely and helps clients reduce utilities and energy costs.