INSIGHTS ON REGULATORY COMPLIANCE
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![DD 3 - PFS Grouping 002]( "Lifecycle Planning For Containment And Delivery Of Biologics Drug Products")
Lifecycle Planning For Containment And Delivery Of Biologics Drug ProductsRead more about trends in the biologics market that could impact the lifecycle strategies for your drug product and steps you can take around drug packaging early in development.
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![GettyImages-1322464926-visual-inspection-vial-laser]( "6 Things To Consider During Visual Inspection Operations")
6 Things To Consider During Visual Inspection OperationsEven with automation, manual visual inspection remains vital in sterile drug manufacturing. Discover six advanced considerations for refining your operations, ensuring compliance, and minimizing costs.
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![GettyImages-508496956-dna]( "Streamlining Data For Efficient Therapeutic Manufacturing")
Streamlining Data For Efficient Therapeutic ManufacturingAn integrated solution for impurity and sterility analysis streamlines data, supports regulatory compliance, and uses built-in algorithms to deliver accurate, actionable results quickly.
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![Filtration Unfiltered: Technology To Meet New Bioprocessing Challenges]( "Filtration Unfiltered: Technology To Meet New Bioprocessing Challenges")
Filtration Unfiltered: Technology To Meet New Bioprocessing ChallengesExplore how filtration strategies are adapting to diverse molecule pipelines, regulations, and sustainability targets with insights into process intensification and the technologies shaping the future.
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The Shift To GMP-Compliant Automation In CGT Manufacturing10/6/2025
Manual processes are yielding to automated, GMP-compliant closed systems in CGT manufacturing. This shift is crucial for meeting Annex 1 contamination standards and creating scalable, reliable commercial production.
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X-Ray Inspection For Supplement Safety2/6/2025
Wellington Foods ensures dietary supplement safety using METTLER TOLEDO’s X37 X-ray system, which detects contaminants, and meets regulatory standards with high-speed, precise inspection technology.
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EU ANNEX-1 And The Impact Of Contamination Control Strategy On Cleaning & Disinfection10/21/2024
New EU rules tighten grip on contamination control for sterile drugs. Learn how to ensure your cleaning and disinfection meet the stricter standards.
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Integrating Phase-Appropriate Quality Standards12/9/2024
Incorporating phase-specific quality standards ensures GMP compliance. Collaborating with an experienced CDMO addresses late-stage quality needs and efficiently manages development timelines.
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Tackling Residual DNA Testing In Biotherapy Manufacturing7/16/2025
Controlling residual host cell DNA is critical for the safety and efficacy of biotherapeutics. Learn about robust, highly sensitive analytical methods for effective DNA clearance and process control.
REGULATORY COMPLIANCE SOLUTIONS
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![Pharma Manufacturing 450x300]( "Continuous Monitoring Of Cleanrooms And Isolators")
FMS/BioTrak/Portable/Remote/Environmental Sensors
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![Audit and inspection-iStock-1205235181]( "Corrective Action Preventive Action (CAPA) Software For Life Sciences")
Quality events are inevitable, no matter how much care is taken to avoid them. As a critical part of a quality management system, CAPA identifies and addresses the root causes of high-risk quality issues and helps to limit the resulting business impact, both immediately and in the future.
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![West-DELIV 2 - GC_App_^CZ vial with stopper and seal stack up]( "Proven Vial Containment That Scales From R&D To Commercial")
Speed up your time to market and reduce your risk of selecting individual components that may not work well together by choosing the Ready Pack containment solution.
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![CellGenix® Portfolio]( "High-Quality Raw Materials For Cell And Gene Therapy Manufacturing")
Explore growth factors and cytokines for regenerative medicine and cell and gene therapies offered in both GMP and preclinical grades.
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![Regulatory compliance Getty Images-1256156511]( "Quality, Compliance, And Regulatory Services For Life Sciences")
The biotechnology, medical device, and pharmaceutical industries are highly regulated globally by a diverse group of agencies. Assuring GMP Quality and Regulatory Compliance throughout your supply chain is a challenge. Meeting this challenge requires a successful interaction between knowledge, systems, and people.
