Our engineers have extensive experience and knowledge regarding processes and unit operations in the (bio-)pharmaceutical industry. Our technical expertise, combined with thorough process and GxP knowledge, ensures that the design will meet all your needs and requirements.

We have in-depth knowledge of regulatory guidelines for small molecules and large molecules (biologicals). In addition, we specialize in ATMP products, as set out in EU Guidelines on Good Manufacturing Practice specific to Advanced Therapy Medicinal Products.

Thanks to numerous projects that we have successfully completed, we have a strong knowledge base of these systems and Good Manufacturing Practice (GMP) standards. We provide excellent consultancy services in this area, tailor-made if desired. We can identify any bottlenecks during implementation in advance to improve quality and user-friendliness. 

Our expertise:

• New- (green field) and revamp of facilities (brown field)
• Cleanrooms and air processing (HVAC)
• Upstream processes (fermentation, centrifugation, etc.)
• Downstream processes (precipitation, chromatography, (ultra-) filtration, etc.)
• Aseptic filling
• Cleaning-In-Place (CIP)
• Sterilization-in-Place (SIP)
• Sterilization
• Freeze drying
• Water- and steam preparation (water for injection (WFI), purified water, clean steam)
• Clean gasses (N₂; CO₂) and clean compressed air (CCA)
• Containment / operator exposure reduction (for example facilities for BSL-2, BSL-3, highly potent substances, and radioactive substances)
• Destruction autoclave and kill systems
• Powder or liquid transport- and handling systems

Brown field: Revamp projects: upgrade current facilities
In many cases, existing facilities no longer meet current pharmaceutical standards, the level of process automation needs an update, or the capacity of the cleanrooms does not meet current demand. In these cases, strong interaction between departments is critical to minimize downtime, avoid out-of-stock situations, and minimize the impact of other operational processes and projects. These “brown field” projects require different project management, project organization and communication than “green field” facilities to limit business risks. Progress project managers and engineers have excellent Project Management skills and solid experience with revamp projects, tailor-made solutions and work closely with your organization.

Complete project life cycle
Progress is your partner for Engineering and Qualification projects related to production, pilot plants and laboratory facilities in the (bio-)pharmaceutical and healthcare industry. We can manage, organize, and/or execute your project from feasibility through to transfer to operation of a qualified and validated facility and/or process. We have extensive knowledge of current guidelines, including the United States Food and Drug Administration (FDA) guideline: Process Validation: General Principles and Practices.

How can we help you?
We can manage or support your new building or revamp project in terms of both layout and construction, complete with cleanrooms and support areas, utilities, production processes, laboratories and all associated process and analytical equipment. We ensure that your facility meets current standards, such as the EudraLex Volume 4 Good Manufacturing Practice guidelines