Analytical Advancements for Biologics Trends Shaping the Future of Biologics Manufacturing: Building resilient, adaptable operations capable of evolving alongside the rapid transformation of the biologics industry is key for downstream processing.

The article focuses on advancements and challenges in downstream purification within biologics manufacturing, emphasizing how increased upstream productivity has outpaced downstream capacity, creating bottlenecks that affect timelines, costs, and commercial potential. It highlights the need for proc...

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Publicado en:Pharmaceutical Technology Vol. 50; no. 4; pp. 8 - 12
Autores principales: GOLDSTEIN, ADAM, NOLASCO, MICHELLE
Formato: pictorial questions and answers Journal Article
Publicado: MJH Life Sciences Jul/Aug2026
Acceso en línea:Ver este registro en EBSCOhost
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      place: Cranbury, New Jersey
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        atl: Analytical Advancements for Biologics Trends Shaping the Future of Biologics Manufacturing: Building resilient, adaptable operations capable of evolving alongside the rapid transformation of the biologics industry is key for downstream processing.
      aug:
        au:
          GOLDSTEIN, ADAM
          NOLASCO, MICHELLE
        affil: Senior director, R&D, Thermo Fisher Scientific
      sug:
        subj:
          Pharmaceutical Companies Trends
          Technology, Pharmaceutical Trends
          Biological Products
          Organizational Change
          Organizational Efficiency
          Health Care Reform
          Implementation Science
          Organizational Compliance
          Organizational Development
          Machine Learning
          Quality Control (Technology)
          Antibodies, Monoclonal
          Cell Therapy
          Gene Therapy
          Productivity
      ab: The article focuses on advancements and challenges in downstream purification within biologics manufacturing, emphasizing how increased upstream productivity has outpaced downstream capacity, creating bottlenecks that affect timelines, costs, and commercial potential. It highlights the need for process intensification, flexible system design, and integration of real-time analytics—such as Raman-based process analytical technology (PAT) combined with artificial intelligence (AI) and machine learning (ML)—to improve throughput, scalability, and product quality. The article also discusses sustainability improvements through reduced buffer and water usage, the importance of regulatory compliance, and the role of industry collaboration in accelerating innovation and adoption of new technologies. Future downstream strategies are expected to prioritize modularity, flexibility, and incremental improvements to accommodate diverse therapeutic modalities and evolving manufacturing demands.
      pubtype: Trade Publication
      doctype:
        pictorial
        questions and answers
        Journal Article
      ougenre: Article
    language: English
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