Major trends boosting CDMO evolution

● Implementing advanced digital manufacturing and analytical technologies

● Accelerating development by effectively leveraging technology transfers and streamlining validation pathways

● To bring forth standardized processes, streamlined protocols, and templated documentation to drive speed and efficiency as part of tech transfer

● Providing a more adaptive accelerated End-toEnd solution

● Adopt integrated process flows between latestage technology transfer and robust process validation

● Regularise Single-Use Technology (SUT) by deploying automated equipment to avoid bioreactor contamination

● Strengthening biologics capacity by investing in new lines and facilities to pace with the booming Biologics market

● Adopt Multi-Attribute Methodology (MAM) workflow to replace multiple product assays with a single assay, resulting in lower costs and shorter timelines

● Increasing focus on “oral solid dose (OSD)” forms for cancer treatments to harness highly potent active pharmaceutical ingredients (HPAPIs) to enhance bio-availability

● Further scrutinizing and defining the policies, have well-documented regulatory guidance, offers low and pre-defined licensing costs

● Identify and quantify critical quality attributes (CQAs) with novel tools to define a pharma product

● Demonstrating expertise to scale a large bioproduction process that can yield high titer, shorter timeline deliveries

● Collaboration across the CDMO continuum with cloud connectivity to identify gaps and implement innovative technologies.

● Revolutionizing data management and making data-driven decisions to seamlessly improve bioprocessing process development

● Streamline processes to deliver the highest quality product, reducing cost, and shortening timelines, High-quality standards verified by audits

● Enhance pharma capacity and capability needs in light of potential supply chain disruptions, geopolitical considerations, and the competitive landscape as a result of pandemic