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...
| Publicado en: | Pharmaceutical Technology Vol. 50; no. 4; pp. 8 - 12 |
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| Autores principales: | , |
| Formato: | pictorial questions and answers Journal Article |
| Publicado: |
MJH Life Sciences
Jul/Aug2026
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| Acceso en línea: | Ver este registro en EBSCOhost |
| fields | @attributes: recordID: 1 pdfLink: plink: https://search.ebscohost.com/login.aspx?direct=true&db=ccm&AN=195920004&site=ehost-live header: @attributes: shortDbName: ccm uiTerm: 195920004 longDbName: CINAHL Complete uiTag: AN controlInfo: bkinfo: dissinfo: jinfo: jid: 15432521 4FK jtl: Pharmaceutical Technology issn: 15432521 maglogo: N pubinfo: dt: Jul/Aug2026 vid: 50 iid: 4 pid: 54670 pub: MJH Life Sciences place: Cranbury, New Jersey artinfo: ui: 195920004 195920004 195920004 195920004 ppf: 8 ppct: 4 formats: fmt: – @attributes: type: T – @attributes: type: P tig: 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 refInfo: holdings: @attributes: islocal: N |
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