INSIGHTS ON QUALITY CONTROL

• Building R&D Knowledge Into GMP Documentation

  Integrating R&D knowledge into GMP documentation ensures consistent aseptic powder fill‑finish processes by capturing material insights, defining controls, and enabling reliable, knowledge‑driven manufacturing.

• Platform Strategy For Improving Manufacturability And Efficacy In Bispecific Antibodies

  Novel bispecific antibody engineering overcomes assembly and manufacturability challenges, enabling scalable production while preserving therapeutic function, stability, purity, and product quality.

• The Hidden Costs Of Paper Logbooks

  Stop losing time and capacity to manual paperwork. Learn how digital workflows eliminate compliance risks and unlock the actionable data needed to optimize life sciences manufacturing.

• ISO/TR 14644 -21:2023 Cleanrooms And Associated Controlled Environments — Part 21: Airborne Particle Sampling Techniques.

  Avoid common sampling errors and ensure cleanroom compliance. Master correct probe placement and tubing configurations to align with the latest industry standards and improve data accuracy.

• How To Double Up With A CDMO To Reduce Risk

  12/12/2025

  Parallel operations with a CDMO can reduce risk and accelerate timelines by enabling simultaneous process development and manufacturing. Learn how this approach supports facility design.

• 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.

• Ensuring Compliance For Virtual And Hybrid Pharmaceutical Companies

  10/16/2025

  Proactive, risk-based oversight must be established to manage outsourced GXP activities. This requires a robust QMS and comprehensive quality agreements to safeguard product quality and data integrity.

• Minimizing Drug Product Loss In Manufacturing

  3/17/2026

  Explore how optimized analytical testing, reduced material wastage, and advanced sterile fill-finish technologies can work together to preserve valuable GMP material without compromising quality.

• Accelerate Biologics Product Release With Seamless Viral Testing

  6/23/2025

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