Richter BioLogics https://www.richterbiologics.eu/de/ Thu, 06 Aug 2026 09:51:11 +0000 de hourly 1 https://wordpress.org/?v=7.0.3 https://www.richterbiologics.eu/wp-content/uploads/2021/01/4c_Logo_Richter_Biol_rgb-150x150.jpg Richter BioLogics https://www.richterbiologics.eu/de/ 32 32 Development, Manufacturing, and Continuity https://www.richterbiologics.eu/de/development-manufacturing-and-continuity/ https://www.richterbiologics.eu/de/development-manufacturing-and-continuity/#respond Thu, 06 Aug 2026 09:50:45 +0000 https://www.richterbiologics.eu/development-manufacturing-and-continuity/ As biologics programs move closer to commercialization, timelines tighten and expectations for quality, regulatory readiness and scalability increase. Decisions made during development increasingly shape manufacturing performance, technology transfer and commercial readiness, making execution risk just as important as scientific progress. Backed by deep expertise in process and analytical validation and process performance qualification, the Germany-based […]

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]]> https://www.richterbiologics.eu/de/development-manufacturing-and-continuity/feed/ 0 Null Beanstandungen. Vollstes Vertrauen. Das bedeutet es, Ihr Produkt auf den Markt zu bringen – gemeinsam mit uns. https://www.richterbiologics.eu/de/null-beanstandungen-vollstes-vertrauen-das-bedeutet-es-ihr-produkt-auf-den-markt-zu-bringen-gemeinsam-mit-uns/ Tue, 23 Jun 2026 08:41:27 +0000 https://www.richterbiologics.eu/null-beanstandungen-vollstes-vertrauen-das-bedeutet-es-ihr-produkt-auf-den-markt-zu-bringen-gemeinsam-mit-uns/ Wenn eine Aufsichtsbehörde vier Prüfer entsendet, um jedes System, jeden Batch Record und jede Qualitätsentscheidung des Unternehmens zu überprüfen – dann sprechen die Ergebnisse für sich. Unsere jüngste FDA-Inspektion erstreckte sich über sechs Tage. Jedes System wurde überprüft. Das Ergebnis: null Beanstandungen. In der Herstellung von Biologika stellen FDA-Inspektionen den höchsten Standard der betrieblichen Überprüfung […]

Der Beitrag Null Beanstandungen. Vollstes Vertrauen. Das bedeutet es, Ihr Produkt auf den Markt zu bringen – gemeinsam mit uns. erschien zuerst auf Richter BioLogics.

]]> Elevating Cell and Gene Therapy: Why Richter BioLogics is the Strategic CDMO Choice for pDNA Manufacturing https://www.richterbiologics.eu/de/elevating-cell-and-gene-therapy-why-richter-biologics-is-the-strategic-cdmo-choice-for-pdna-manufacturing/ Thu, 23 Apr 2026 10:01:39 +0000 https://www.richterbiologics.eu/elevating-cell-and-gene-therapy-why-richter-biologics-is-the-strategic-cdmo-choice-for-pdna-manufacturing/ The rapid advancement of Cell and Gene Therapy (CGT) has positioned plasmid DNA (pDNA) as a critical therapeutic cornerstone. Whether utilized as an active pharmaceutical ingredient in DNA vaccines, a template for mRNA therapeutics, or a vital raw material for viral vector production, there is a constant demand for pDNA production. However, the biopharmaceutical industry […]

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]]> Enhancing Compliance and Efficiency with a Unified Quality Management System https://www.richterbiologics.eu/de/enhancing-compliance-and-efficiency-with-a-unified-quality-management-system/ Wed, 08 Apr 2026 09:58:54 +0000 https://www.richterbiologics.eu/enhancing-compliance-and-efficiency-with-a-unified-quality-management-system/ By Birte Müller at Richter BioLogics Why CDMOs should consolidate their QMS landscape and how to do it well Quality management systems (QMS) that are not continuously challenged and optimised pose compliance risks, slow down operations and consume valuable resources. For contract development and manufacturing organisations (CDMOs), the challenge is amplified; systems must meet both […]

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]]> Beyond the monoclonal: the ascendance of single-domain antibodies and fragments in biopharma https://www.richterbiologics.eu/de/beyond-the-monoclonal-the-ascendance-of-single-domain-antibodies-and-fragments-in-biopharma/ Mon, 16 Mar 2026 16:23:37 +0000 https://www.richterbiologics.eu/beyond-the-monoclonal-the-ascendance-of-single-domain-antibodies-and-fragments-in-biopharma/ Richter BioLogics discusses the company capabilities, capacities and expertise in producing VHH/nanobodies for clinical and commercial purposes. or decades, full-length monoclonal antibodies (mAbs) have dominated the biopharma landscape, serving as the gold standard for targeted therapeutics. However, a significant paradigm shift is currently underway. As the industry pivots towards smaller indication scopes and moves away […]

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]]> Adapting success factors from customer project management to internal projects within a CDMO https://www.richterbiologics.eu/de/adapting-success-factors-from-customer-project-management-to-internal-projects-within-a-cdmo/ Mon, 02 Feb 2026 13:19:36 +0000 https://www.richterbiologics.eu/adapting-success-factors-from-customer-project-management-to-internal-projects-within-a-cdmo/ Most contract development and manufacturing organisations prioritise customer project management to maintain high standards and ensure flexibility in meeting client requirements. However, the coordination of internal projects is often underestimated, despite its significant impact on customer satisfaction By Tobias Meder at Richter BioLogics Richter BioLogics GmbH (RB), a microbial contract development and manufacturing organisation (CDMO), […]

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]]> Excellence in biologics manufacturing: why Richter BioLogics is your partner of choice https://www.richterbiologics.eu/de/excellence-in-biologics-manufacturing-why-richter-biologics-is-your-partner-of-choice/ Mon, 02 Feb 2026 13:18:28 +0000 https://www.richterbiologics.eu/excellence-in-biologics-manufacturing-why-richter-biologics-is-your-partner-of-choice/ The process of bringing life-saving biotherapeutics to market is both time-consuming and complex. With over 35 years of experience, Richter BioLogics is renowned as a premier contract development and manufacturing organisation (CDMO), consistently delivering best-in-class services and maintaining an exceptional reputation within the industry. Our core area of expertise and competence Richter BioLogics is keeping […]

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]]> Gewinner und Champion des 1. CDMO Leadership Award EUROPE 2025 in der Kategorie „BioLogics“ https://www.richterbiologics.eu/de/gewinner-und-champion-des-1-cdmo-leadership-award-europe-2025/ Tue, 11 Nov 2025 08:25:07 +0000 https://www.richterbiologics.eu/gewinner-und-champion-des-1-cdmo-leadership-award-europe-2025-in-der-kategorie-biologics/ 28. Oktober 2025: Und der Gewinner ist – Richter BioLogics! Wir sind begeistert und fühlen uns gleichzeitig sehr geehrt, zum Gewinner und Champion des 1. 2025 CDMO Leadership Award EUROPE in der Kategorie „BioLogics“ gekürt worden zu sein.Ein großes Dankeschön geht an alle Teams von Richter BioLogics – diese Auszeichnung gehört jedem einzelnen Kollegen und […]

Der Beitrag Gewinner und Champion des 1. CDMO Leadership Award EUROPE 2025 in der Kategorie „BioLogics“ erschien zuerst auf Richter BioLogics.

]]> Benefits of Mass Spectrometry from Process Development to GMP Release of Biomolecules https://www.richterbiologics.eu/de/benefits-of-mass-spectrometry-from-process-development-to-gmp-release-of-biomolecules/ Mon, 13 Oct 2025 14:22:22 +0000 https://www.richterbiologics.eu/benefits-of-mass-spectrometry-from-process-development-to-gmp-release-of-biomolecules/ A Comprehensive CDMO Perspective from Richter BioLogics By Dr. Maja Erdmann, Daniel Goetz, Dr. Daniela Stummer and Dr. Ingo Goldbeck at Richter BioLogics In biopharmaceutical production, a thorough understanding of analytical processes and target molecules is essential for ensuring patient safety, as well as maintaining consistent and reliable product quality. Mass spectrometry (MS) represents a […]

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]]> Key aspects to control assays throughout the analytical life cycle https://www.richterbiologics.eu/de/key-aspects-to-control-assays-throughout-the-analytical-life-cycle/ Thu, 26 Jun 2025 11:39:22 +0000 https://www.richterbiologics.eu/key-aspects-to-control-assays-throughout-the-analytical-life-cycle/ For biopharmaceutical products, potency testing is a requirement through all phases of clinical investigation and following market approval. Due to the complexity and inherent variability of this type of analysis, an assay control strategy should be established for each specific product, adapted and improved throughout the analytical life cycle By Sonja Klingelhöfer at Richter BioLogics […]

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