INSIGHTS ON QUALITY CONTROL

• Achieving Titer Increase Up To 4-Fold While Maintaining Product Quality

  Discover customizable solutions for antibody manufacturing, as well as services for media optimization, feeding strategy optimization, and format conversion.

• Revolutionizing The Development, Characterization, And Manufacturing Of Peptides

  Erik Feldmann, Technical Director, on the analytical challenges of proteins, peptides, and oligonucleotides — and why he starts every method-development problem by understanding what the customer is trying to achieve.

• Accelerate Biologics Product Release With Seamless Viral Testing

  Explore viral safety testing for biologics, focusing on prevention, detection, and removal strategies, updated regulatory guidance, and common challenges in unprocessed bulk testing.

• The AI Advantage For Regulated Manufacturing

  Transitioning from paper batch records to human-centered AI optimizes pharma manufacturing. Learn to secure data, cut review times by 90%, and build a strong Return on Automation business case.

• Lessons From FDA 483s And Warning Letters: Cleanroom Compliance

  12/8/2025

  Learn critical lessons from FDA 483 observations and Warning Letters to proactively address common GMP cleanroom compliance failures and build an inspection-ready facility.

• Software Simplifies 21 CFR Part 11 and Annex 11 Compliance

  12/9/2024

  21 CFR Part 11 and Annex 11 regulate electronic records and signatures in biomanufacturing, ensuring data integrity, security, and compliance while enabling efficient processes and regulatory alignment.

• The Pain Of Change – Could Suppliers Be Part Of The Cure?

  10/15/2024

  Change is a constant in the pharma industry, but it doesn't have to be painful. Discover how suppliers can help ease the burden of regulatory change management and streamline essential processes.

• Ready To Bring GxP Training To The Next Level? LearnGxP

  4/24/2026

  Upgrade your compliance strategy with accredited, scenario-based GxP training. Eliminate risks like failed inspections and costly deviations with a modern, global solution.

• Thermal Analysis In The Pharmaceutical Industry

  12/30/2024

  Thermal analysis techniques provide valuable insights into pharmaceutical material properties, ensuring compatibility, stability, and quality control in drug development and production processes.