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1. Preparing For FDA's Expanded Use Of Unannounced Inspections At Foreign Manufacturing Facilities 7/10/2025

   The FDA announced on May 6, 2025, that it intends to expand its use of unannounced inspections at foreign manufacturing facilities. Here are key considerations and actions to take in order to be prepared.

2. 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.

3. 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.

4. 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.

5. 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.

6. Controlled Production Of MSC-Derived Extracellular Vesicles In Stirred-Tank Bioreactors 7/9/2025

   Learn how stirred-tank bioreactors overcome the scalability limitations of static culture for MSC-EV production, while Raman spectroscopy provides unprecedented real-time quality monitoring during production.

7. Metabolic Phenotype Preservation And Suitability Of hMSCs Cultivated In Stirred Tank Bioreactors 7/9/2025

   Learn how researchers demonstrated scalable hADSC expansion in stirred-tank bioreactors using microcarriers, achieving metabolic stability and consistent growth for cell therapy applications.

8. Automated Sampling Of A Four Vessel Parallel CHO Cell Culture 7/9/2025

   Learn how automated sampling for parallel bioreactors enables continuous, sterile sample collection from CHO cell cultures, maintaining cell density with reduced manual intervention.

9. Tackling CGT Challenges: Stirred-Tank Bioreactors For R&D And Commercial Manufacturing 7/8/2025

   Scalability remains a key bottleneck in CGT manufacturing. See how optimized stirred-tank bioreactor systems accelerate translation from clinical to commercial production.

10. Single-Use Bioreactors For Cell Culture, Fermentation, And Commercial Manufacturing 7/8/2025

    Enhance your bioprocessing with single-use bioreactors that offer broad compatibility, reduced turnaround times, and consistent product yield through innovative design and flexible scalability.