What are “3 Key Trends” shaping the CDMO industry in 2022 and beyond? Samsung Biologics’ executive vice president and chief business officer, James Park, shares his thoughts with Con-tract Pharma.

Supporting Innovations in Biopharma with Multimodality and Flexibility

The innovative, progressive nature of biopharmaceutical development provides patients with ever more effective biologics. However, supporting the delivery of these essential drugs at a commercial scale is increasingly challenging as biologics become more complex.

The COVID-19 pandemic highlighted the need of CDMOs to offer flexibility to rapidly adapt to support manufacturing of previously widely unfamiliar mRNA-based vaccines. Manufacturers had to respond to the unprecedented demand by expanding capacity and facilities to serve the dynamic market changes and balance existing and new projects. This entailed offering more robust technologies and cold chain capabilities to effectively meet the demand.

As mRNA treatments become more advanced, targeting advanced cancers and heart disease, and the potential of cell and gene therapies widens, offering adaptability and flexibility to sup-port these projects is critically important. By preparing for the multi-modalities of new tech-nologies, these CDMOs have subsequently placed themselves in good stead for an array of new therapeutics on the horizon, including multi-modal mRNA, plasmid DNA (pDNA), viral vectors and other gene therapy products.

End-to-End Services

To ensure patients receive vital biologics at speed, their development and manufacture must avoid all potential delays. However, during the COVID-19 pandemic, high demand for urgent vaccines was at odds with supply delays. These delays could be further exacerbated by time taken for tech transfer to multiple CDMOs.

As speed-to-market priorities remain strong and COVID-19-associated delays become a com-mon occurrence moving forward, biopharma will look to manufacturing partners ready to fulfill their drug strategies start-to-finish with end-to-end capabilities. Offering these services is prompting the CDMOs in the space to expand both their capabilities and facilities.

Those CDMOs expanding to provide end-to-end services will not only minimize the impact of potential delays but improve overall efficiency. These include both accelerated processes, cost efficiencies, reduced resource requirements and simplified technology transfers.

Speed to Market

It is imperative that essential biologics are delivered to patients as fast as possible while main-taining high quality. The COVID-19 pandemic applied further pressure on CDMOs to deliver this offering as the demand for urgent vaccines was witnessed globally.

However, production of biologics is fraught with challenges and potentially time-consuming processes that can be at odds with accelerating market timelines. Technology transfer com-plexities, lengthy timelines to Investigational New Drug (IND) and Biologics License Application (BLA), and dated data management systems are prevalent challenges.

Minimizing the impact of these obstacles to improve project timelines can be achieved in vari-ous ways. Adapting and expanding facilities to offer robust and proven end-to-end processes can obviate potential delays associated with tech transfer. Optimization of development pro-cesses with an overarching strategy to produce a streamlined platform approach can expedite the timeline to IND and BLA. Finally, implementing robust digitalization approaches to intro-duce digital technologies could act to further harmonize processes and increase efficiency.

Fast delivery of high-quality drugs to patients therefore requires careful evaluation of every as-pect of biologic development and manufacturing. Processes, capabilities and facilities must be adapted and optimized to meet the demand for speed that is likely to continue in the future.

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Samsung Biologics is a fully integrated CDMO offering contract development, manufacturing and analytical services. With proven regulatory approvals, the largest capacity at a single site, and fast throughput, Samsung Biologics can support every stage of the process while meeting the evolving needs of biopharmaceutical companies worldwide.