Biosimilar Manufacturing solution center
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A Guide To Accelerating Cell Line Development For Commercial Production
7/11/2025
Explore the challenges associated with cell line development in the production of biologics, and solutions that can help biotech developers evade the pitfalls of misinformed decision-making.
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Pharma Enterprise Resource Planning: From Automation To AI-Driven Insights
7/10/2025
Pharmaceutical firms are increasingly turning to enterprise resource planning (ERP) systems to modernize operations. These platforms unify core functions, including supply chain management, manufacturing, and financial planning and analysis.
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Managing Extractables And Leachables In HPAPI Manufacturing
7/10/2025
These contaminants can compromise the quality, stability, and safety of a drug product, and regulatory bodies mandate assessment to protect patients.
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Unlocking Value In Biopharma Operations: A C-Suite Call To Action
7/9/2025
Operational readiness will separate the leaders from the laggards, whether you lead a pharma/biotech innovator, CDMO, or a combination of both.
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Audit Trail Compliance And What To Look For In Mitigation Software
7/9/2025
In the pharma/biotech and medical device industries, the audit trail is important to have for accountability, data integrity, repeatability to create an event for investigation, and regulatory compliance.
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The New Clinical Packaging Paradigm: Differentiation And Decentralization
7/8/2025
The rapid evolution toward flexible, decentralized clinical supply models is placing unprecedented strain on traditional clinical packaging organizations. Can traditional models adapt fast enough to stay viable?
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Process Validation: Optimizing Operational Excellence In Pharma And Medical Devices
7/3/2025
Process validation is often viewed as a costly regulatory formality. However, it is actually a strategic investment that, when integrated into business planning, delivers measurable outcomes in productivity, compliance, speed-to-market, and profitability.
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Efficiently Select Your Antibody Or Antibody Variant Purification Strategy
7/1/2025
Explore the evolution of antibody therapeutics from monoclonal antibodies to next-gen formats and discover innovative strategies for purifying these complex molecules in today’s landscape.
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Efficiently Select And Optimize Antibody Candidates
7/1/2025
Discover how innovative systems streamline antibody development to enhance target-binding analysis, optimize therapeutic selection, and accelerate clinical success with precision tools.
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AI-Assisted QMS: Bridging ISO/IEC 42001:2023 And ICH Q10 For Pharmaceutical Excellence
6/23/2025
Integrating AI into quality management systems (QMS) can be a transformative opportunity to enhance quality assurance, improve compliance, and enable proactive risk management.