BioSpectrum Asia

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

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