INSIGHTS ON QUALITY CONTROL

• Challenges In Developing Medical Devices From Animal-Based Biomaterials In China

  Bovine collagen, valued for biocompatibility and versatility, is gaining attention for medical devices in China as regulatory barriers ease, though safety assurances remain crucial.

• Ask Us Anything: Mark Benger On Solid-State Strategies For Drug Development

  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.

• Software Simplifies 21 CFR Part 11 and Annex 11 Compliance

  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.

• Enhancing Safety In Drug Substance Synthesis: A Smart Approach To Chemical Design

  Discover how safety‑by‑design principles in chemical synthesis help control exothermic reactions, reduce scale‑up risk, and enable safer, more reliable manufacturing of complex drug substances.

• Trend Analysis Of Particle Monitoring Data And Defining Alert And Action Limits

  9/9/2026

  Routine trend analysis of total and viable particle monitoring data helps identify operational shifts early, set statistical limits, and strengthen cleanroom contamination control strategies.

• Why US Pharma Manufacturing Delivers Strategic Value

  7/28/2026

  Domestic pharmaceutical manufacturing strengthens supply chain resilience, simplifies distribution, speeds market response, and reduces risk by aligning production with key markets.

• Inside The Cleanroom: Building A Culture Of Clean Beyond The CCS Blueprint

  2/12/2026

  Achieving sterile excellence requires more than just rigid protocols. Learn how to foster a proactive mindset across your entire organization to ensure long-term facility integrity.

• Nutraceutical Packaging Inspection: Challenges, Technologies, And Solutions For Supplement Manufacturers

  7/24/2026

  Advanced X-ray inspection, metal detection, and checkweighing technologies ensure fill accuracy, eliminate contaminants, and protect nutraceutical brands.

• The Art And Science Of Getting Tech Transfer Right First Time

  7/21/2026

  Technology transfer connects drug development to scalable manufacturing through early engagement, open knowledge sharing, and data-driven methods like Design of Experiments to safely advance therapies.