The Challenges of Multiproduct Facility Design
Since human therapeutics have rapidly evolved from small molecules to include complex biological products such as monoclonal antibodies (mAbs), viral vectors, autologous and allogeneic cell therapies, mRNA therapeutics, drug manufacturers and contract development and manufacturing organizations (CDMO) are considering how to design and operate multiproduct facilities to maintain agility and adaptability. Flexibility, scalability, and speed to market are the key factors driving this endeavour to produce non-viral biologics products, Advanced Therapy Medicinal Products (ATMPs) and mRNA therapeutics. The main challenges are linked to the variability between different technology and manufacturing equipment, diverse processes, logistic requirements for example, of incoming cells, starting material and the distribution and delivery of the final products that can differ radically from therapy to therapy. Products targeting rare diseases required usually small batches but larger batch sizes are required for larger population affected with common genetic disorders. These different product manufacturing processes are complex and their specific risks need to be addressed when designing multi-products facilities. Adaptable facilities are required to facilitate rapid change, based on manufacturing needs for different product processes, without significant modification of the facility and quickly add or remove corresponding supporting utility services.
