Complete Support for New Biopharma Production
Building agile and flexible biopharmaceutical factories requires careful consideration of how the designed and built to get the best outputs for your unique needs.
Working closely with leading modular cleanrooms and facility engineering and construction companies, we will partner with your team to find the right solution to bring your project to life.
Typically, we follow a 4 phased approach with clients looking at facility investments:
- Conceptual design (Feasibility study)
- Basic design
- Detailed design
- Facility construction and delivery
The first step of the exercise is to consider the overall process at all relevant scales and equipment required to meet these needs. During a two day conceptual design interactive workshop, we jointly build a sound business case to meet your unique situation through knowledge sharing and information exchange.
The result is a general facility layout with all the specifics around equipment, personnel flow, and material flow, allowing you to determine of the staffing requirements and productivity levels of the facility. And, you’ll have the OPEX and the CAPEX estimates for the facility based on process scale production.
Working closely with our Architectural & Engineering partners, we will bring your project to full completion so that you facility is ready, on time, to start your process tech transfer activities.
|Guidebook: Break Down Roadblocks to Commercial Success
The decision to build your own cGMP biomanufacturing facility is complex, and must ultimately fit your commercial strategy. Discover our guidebook for today’s biopharma executives seeking to navigate through the important considerations necessary to successfully build their own cGMP biomanufacturing facility: business planning, technology, regulatory/risk assessment and engineering.
|Our recent webinar, "The Chronicles of a Biosimilar Production Facility" discusses the challenges you face in designing and constructing a single production facility that can produce different biosimilar monoclonal antibodies, from clinical studies through commercial production.
Brochure: BioReliance® End-To-End Solutions
Whether you are looking to implement proven solutions while reducing costs and mitigating risk, or looking for a partner who will work with you from Process Development through Facility Design and Construction, we have options that will streamline your process.
Merck to Provide BioReliance® End-to-End Solutions for Development and Manufacture of Biosimilars under Strategic Alliance with Turgut Ilaç