Biosimilar Manufacturing solution center
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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.
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Ask The Pros — The Latest In Downstream HCP Mitigation
6/20/2025
Two downstream biologics processing experts address some of the field's complex, nagging questions about mitigating host cell proteins.
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5 Key Considerations For Companies Outsourcing Process Development
6/9/2025
Venture capital in biotech remains strong post-pandemic, especially in cell and gene therapies. Discover five key factors to help companies choose between in-house and outsourced process development strategies.
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Cleaning Process Capability: Understanding Populations, Samples, And Sample Size Requirements
6/6/2025
This article examines the role of sample sizes in the determination of cleaning process capability or process performance in the manufacture of drugs/therapies and medical devices.
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The Matryoshka Model: The New Face Of Contract Packaging In Pharma
6/4/2025
Contract packaging organizations are the outer layer of the pharmaceutical Matryoshka (the iconic Russian nesting doll): the final form that contains within it a series of intricately crafted parts.
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Versatile Lipid Nanoparticle Platform For Efficient Gene Editing
6/3/2025
Lipid nanoparticles enable efficient gene editing in hard-to-transfect cells like T-cells and blood stem cells, which offers scalable, clinically relevant methods for developing advanced therapies for cancer and rare diseases.