Biosimilar Manufacturing solution center

1. UK's Decentralized Manufacturing Could Be A Revolution; Mind The Risk 3/20/2026

   Decentralized manufacture will only improve patient outcomes if the pharmaceutical quality system at the control site is strong enough to carry the weight of the network.

2. All The Ways Global Biopharma Still Grapples With Annex 1 3/19/2026

   Biopharma companies can't consistently meet Annex 1 expectations. At the heart of the problems, regulators have shifted the burden of proof to manufacturers.

3. Clearing The Fog On New First Air Visualization Expectations 3/18/2026

   Assessing first air using standard smoke studies is qualitative in nature, and it's difficult to establish clear criteria. Here is how regulator positions are evolving.

4. Organic Impurities: New Draft ICH Q3E Guidance For Leachables And Extractables 3/17/2026

   A new draft guidance document from ICH, issued jointly with the EMA, adopts the position that the assessment of leachables and extractables requires a holistic framework for risk evaluation.

5. Where Contamination Control Really Breaks Down In Practice 3/13/2026

   Contamination control gaps arise when two dynamics merge — when processes become familiar and workloads increase. Here's how to spot them before they spin out of control.

6. SUS Interchangeability Assessment And Qualification Best Practices 3/12/2026

   Establishing a robust single-use systems (SUS) interchangeability program can be a pivotal feature of a supply chain resiliency initiative.

7. Why You Need Spare Parts On-Hand 3/10/2026

   Unexpected equipment failures can derail timelines and strain budgets. Proactively stocking the right spare parts helps labs minimize downtime, protect productivity, and maintain consistent performance.

8. Benefits Of Preventive Maintenance 3/10/2026

   Preventive maintenance keeps bioprocessing operations steady. Discover why routine service is essential for reliability, safety, and long‑term efficiency across modern manufacturing environments.

9. Enable Predictive Maintenance With IoT Equipment Service Tool 3/10/2026

   Explore how predictive and prescriptive maintenance reduces downtime, strengthens equipment reliability, and supports smoother bioprocess operations to maintain consistent production performance.

10. The Importance Of Preventive Maintenance In Academia 3/10/2026

    Preventive maintenance may be behind the scenes, but it keeps research running smoothly. Explore how proactive equipment care reduces downtime, increases reliability, and supports safety.