Issue link: https://www.e-digitaleditions.com/i/1529207
www.biopharminternational.com Manufacturing and Facilities eBook November 2024 BioPharm International ® 15 Outsourcing Page Header_ one, build many" philosophy, enabling them to de- liver an "ecosystem" of facilities across multiple sites. D i g it a l r e pl ic a t ion e n s u r e s t h a t C DMO s c a n quick ly increase capacit y and suppor t the speedy manufact uring ramp-up t hat biopharma compa- nies require. The underlying strateg y at the heart of this digital approach is modularit y, mitigating risk while also reducing costs and making timelines shorter. Ultimately, the modular approach supports the increased production of potentially life-saving treatments and therapies. From a design perspec t ive, modu la r it y brea k s dow n a scope into standard modules t hat can be con nected in a custom ized way. Modularit y a lso provides a methodolog y for standardized factor y design that allows solutions providers to build iden- tical facilities, irrespective of the location. At the heart of the modular approach is the use of standardized components in design and construc- tion. The more repetitive the use of standardized components, the more modular the facility becomes, allowing for reduced customization and complexity and greater f lexibility. As the CDMO sector contin- ues to grow in support of demand from biopharma clients, the need to buy into the modular philosophy is vital. This project technique is delivering CDMO facil- ities—and whole "ecosystems"—that can adapt to changes in a structured way. And as the biopharma sector continues to innovate and bring new treat- ment s a nd t herapies to ma rket, modu la r i zat ion provides the necessar y f lexibilit y, scalabilit y, and adaptability to support such rapid shifts. Facilities designed using a modularized approach can be easi ly adapted to accom modate changing production volumes, ensuring that their size and capacit y align with market demands without the need for extensive modifications. Digital best practice The digital-led approach to multi-site CDMO deliv- er y also means that solutions providers can lever- a ge e x i s t i n g pa r t ner sh ips to pr oc u re ident ic a l equipment from one vendor. Industry best practice shows t hat up to 95% of equipment for a n ent ire CDMO facilit y ecosystem can be procured in this manner. A modular manufact uring net work for faci lit y design and drug production allows for key project documents to be replicated and the commissioning, qualification, and validation (CQV) process across sites to be leveraged a nd repeated. For exa mple, being able to maintain greater than 95% alignment for user requirement specifications between proj- ects ensures consistency and efficiency in system implementation. An ecosystem of nearly identica l facilities a lso en hances the sca labilit y of standardized testing, commissioning, and qualit y requirements, along with the associated documentation. This facilitates accelerated tech nolog y t ra n sfer across sites, re- duced lead times, and improved operational agility. T hese d igita l repl icat ion feat ures y ield sign i f- icant budget savings, while also greatly reducing hours worked per project, par ticularly in t he de- tailed design (DD) phase. In a facility project utiliz- ing digital replication, hours for completing DD can be reduced 85% from the base design. More broadly, a facilit y delivered using the digita l-led modular approach can be completed within 24 months' lead time and with just 50% of overall onsite hours re- quired for a comparable project. For biopharma customers, the primary impacts of this modular approach are speed and f lexibility. A global network of standardized facilities utilizing harmonized equipment, processes, and procedures drives efficiency. Creating operational consistency across modular facilities—including standardized manufacturing standards and processes—ensures that customers can seamlessly integrate regardless of location, or expand from one location to another, of fering in- creased f lexibility and proximity to market. Delivering safety and sustainability D ig it a l repl ic at ion a l so add resses t wo bu r n i ng industr y issues: at taining and maintaining high sa fet y sta nda rds, a nd ma k ing biopha r ma ma nu- facturing sustainable. By building a modular manufacturing network, each iteration gives solutions providers an oppor- tunity to minimize errors while also leveraging les- sons learned from previous projects. This approach supports a more efficient, cost-effective construc- tion phase, with fewer hours worked on-site. At the heart of the modular approach is the use of standardized components in design and construction.