Featured Bioprocessing Editorial

1. Why Aren't QC Labs Automated? Blame Sample Container Variability 12/11/2024

   Members of the Laboratory Automation Plug and Play group speak up about the factors they see holding back quality control labs from achieving more robust automation.

2. Is Your CDMO Using These AI-Driven Solutions In CMC For Oligos And Peptides? 12/10/2024

   Oligonucleotides and peptides require precise, scalable, and compliant production. CDMOs are integrating AI-driven technologies to answer the call. Many of these technologies are notable for specific needs.

3. Count On Data Integrity Auditors Making These 10 Requests 12/9/2024

   Every audit, however unique, requires confirmation that effective data integrity governance exists, supported by strong SOPs, proper validation, and regulatory adherence.

4. November 2024 — CDMO Opportunities And Threats Report 12/9/2024

   Each month, Outsourced Pharma works in conjunction with PharmSource, part of GlobalData, to present its “Contract Manufacturing: Opportunities and Threats (CMOT) Report” to our readers. The report identifies CDMOs that might be impacted by key events affecting their clients, including company acquisitions, product acquisitions and licenses, product approvals, late clinical product terminations, and FDA rejections.

5. Stage 3a: A Key Indicator For Process Validation Maturity 12/9/2024

   Process validation's stage 3a serves to reconfirm the assumptions made during design space development and is particularly pronounced for new modalities and emerging processes.

6. 5 Characteristics Of Forward-Thinking Microbiology Labs In 2025 12/6/2024

   Improving microbiology laboratory efficiency is a continuum. Here are five tech-forward trends that will impact cost and efficiency in 2025.

7. Bayer's Supply Network-Centric Approach To Digitalization 12/5/2024

   Shifting away from paper records is the nonnegotiable first step toward implementing novel technology. Here's how one company is approaching the monumental task.

8. The Building Blocks For Successful CDMO–Pharma Relationships For Packaging Operations 12/4/2024

   The building blocks of such successful packaging relationships include a thoughtful approach to quality service agreements, a culture of transparency, and more.

9. 2024 Survey Findings: How Is The "Lab Of The Future" Becoming Reality? 12/3/2024

   The Pistoia Alliance conducted a survey as a pulse check on which technologies the pharma/biotech industry is investing in and companies' progress integrating new tech into the lab.

10. USP Chapter Covers Residual DNA Testing Practices For CHO And E. coli 12/3/2024

    Industry widely uses qPCR to measure residual DNA; however, the technique lacked a standard. USP's General Chapter <509> aims to remedy that.