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Scaling biopharma manufacturing without sacrificing flexibility
Biopharmaceutical development has increasingly shifted toward specialised and personalized therapies, such as cell and gene therapies, antibody-drug conjugates and monoclonal antibodies( mAbs), among others. Recently, growing demand for GLP-1 drugs, vaccines and biosimilars has driven the need for large-scale manufacturing.
Together, these diverse demands are creating a more complex manufacturing landscape: one that requires both flexibility and the ability to scale quickly. CDMOs who are designed for flexibility adapt with modular facilities, cross-trained teams and a partnership mentality that embraces sponsors’ ever-changing priorities enable service providers to accommodate client needs.
“ For the large pharma partners we work with, flexible means being adaptable and collaborative with their technical and quality teams to bring their processes to our site efficiently and with high quality,” says Kyle Kissick, MSAT lead at the Cincinnati, Ohio, site for Resilience, a CDMO with biologics drug substance, cell-based therapies, and aseptic drug product manufacturing facilities across North America.“ It’ s about being able to respond to their needs quickly, while finding the best solutions to ultimately serve patient needs.”
Nick Van-Gemert is a senior manager of manufacturing for Resilience at the Toronto, Canada facility. The site, which focuses on process development, GMP manufacturing for mAbs, recombinant proteins and other complex molecules, says emerging biotechs require a different type of flexibility.
“ Our definition of flexibility focuses on being agile for the client” he says.“ Early-phase programmes have tight timelines and shifting priorities, facilitating the need for development and manufacturing activities to happen in parallel, which can go almost up to the date of GMP manufacturing.”
Enabling flexibility through equipment & automation
Equipment selection also enables flexibility, and CDMOs with deep process knowledge can adapt equipment to meet clinical and commercial requirements. Each Resilience facility has adopted platforms that enable flexibility, such as single-use formulation and dosing systems. These provide the opportunity to closely replicate client processes and leverage existing data rather than repeating costly and timeconsuming studies.
Single-use bioreactors and processing equipment at Resilience’ s Toronto facility are designed to accommodate almost all mammalian cell culture products and eliminate sterilisation and changeover time required by fixed stainless-steel systems. All process equipment is also portable and reconfigurable based on client requirements.
Resilience recently stood-up a fully integrated drug delivery, device assembly and packaging platform in less than 18 months to support rapid scale-up for a client experiencing unprecedented global market demand. The programme combined accelerated technology transfer, commercial-scale sterile fill / finish operations, proprietary prefilled syringe( PFS) device assembly, packaging, serialization, and supply chain readiness into a single coordinated manufacturing solution. All fill, assembly and packaging lines are fully automated at Resilience Cincinnati, with a plant-wide historian that captures and trends operational data to support both continuous process improvement and rapid investigation if issues arise.
A flexible CDMO, driven by technology & patient need
Resilience was designed to meet the needs of emerging biotech and large pharma alike using a combination of advanced technology, established quality systems, tested scalable processes and a flexible manufacturing approach. This combination drives efficiency without compromising quality or regulatory compliance.
“ Patient needs have always driven demand for solution providers,” says Van-Gemert,“ but the ability to offer flexible solutions in an environment that is constantly shifting due to new breakthroughs and developments, continuous improvement, and changing geopolitical requirements is becoming a required trait in a CDMO partner.” ●
SEP / OCT 2026 SPECCHEMONLINE. COM
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