INSIGHTS ON QUALITY CONTROL
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Understanding cGMPs For Phase 1 Investigational Drugs
Learn how a structured, risk-based approach to early-phase manufacturing can help streamline processes, reduce costs, and accelerate the path to first-in-human trials while meeting FDA cGMP guidelines.
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Integration Of Container Closure Integrity In Contract Manufacturing
Maintaining drug product sterility and compliance demands rigorous Container Closure Integrity (CCI) within contract manufacturing. Learn how to fortify your processes.
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Digital Process Twin Cuts J&J Production Time And Costs
Virtual process modeling is helping to cut production time, reduce solvent use, and improve sustainability. Learn how digital twins enable faster scaleāup decisions and more efficient manufacturing.
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Top Questions Before You Buy A Hazardous Pharmacy Compounding Isolator
Move beyond brochure specifications for hazardous compounding. Learn the critical airflow, structural, and pressure requirements needed to ensure long-term facility safety.
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Applying AI And Rapid Prototyping To Media And Process Development3/26/2026
Hear from industry experts on how teams can integrate manufacturability considerations earlier through rapid prototyping, data-driven media development, and predictive modeling.
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Connecting GxP Systems Without Compromising Compliance7/17/2026
Discover how connected, purpose-built systems help quality, IT, and operations teams improve collaboration while maintaining compliance across every integration.
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Controlling Nitrosamine Risk In Drug Products: Detection, Formation, And Control Strategies7/31/2026
Bioprocess control relies on clear insight into cell health. Automated tracking cuts risk, saves time, boosts yield, and helps scale up fast to ensure smooth, top quality batch production runs daily.
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It's Time To Leave Paper Behind For Digital Visual Inspection Management5/13/2026
Manual records create unnecessary compliance risks. Learn how digital systems provide the automated version control and traceability required to meet modern regulatory expectations and audits.
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How Solid-State Characterization Shapes Drug Development7/23/2026
Mark Benger, Site Director at Cambrex Edinburgh, on solid-state characterization as an insurance policy — front-loaded work that quietly determines whether a program survives the jump from kilos to tonnes.
QUALITY CONTROL SOLUTIONS
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Check out an integrated solution for materials supply and packaging options provided by an industry-leading supplier of powder containment and transfer solutions.
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Explore how specialized analytical expertise and advanced instrumentation enable precise nitrosamine testing to help drug developers meet strict and evolving regulatory requirements.
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PTI Inspection Systems are scientific instruments being deployed for high risk packaging applications. The environments in which these systems operate is often highly regulated with test results having a significant impact on operational decisions. The reliability and sensitivity of a CCI test method is critical to assure that correct decisions are made to maintain product quality and patient safety. If PTI’s equipment is going to test your packaging, we aim to deliver the most effective solution. Feasibility studies offer a detailed glimpse into the technological capabilities ahead of critical purchasing decisions. Feasibility studies can also act as a preliminary test method for an application. The results from feasibility or method development testing can be rolled out to the production environment for rapid validation and deployment.
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Realize the full potential of your cell therapy research. Experience end-to-end support to overcome developmental complexities, helping you to efficiently and safely commercialize your groundbreaking treatments.
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Explore an extensive analytical chemistry and microbial testing compliant portfolio for pharmaceutical analysis and quality control (QC) from early-stage drug development to product release.