Biosimilar Manufacturing solution center
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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.
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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.
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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.
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Best Practices For Chromatography Column Packing
12/6/2024
Proper packing for resin is crucial to prevent issues like cracking or channeling which can lead to process disruptions and product loss.
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Packing MabSelect™ And MabSelect SuRe™ Resins Using Verified Methods
12/6/2024
Proper packing of MabSelect resins is crucial for efficient chromatography. Verified methods ensure stability, optimal flow, and reproducibility across scales using automated tools.
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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.
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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.
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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.
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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.
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Are We Witnessing A New "Age Of The CDMO"?
12/3/2024
Over the past few years, the pharma/biotech industry has seen a significant shift from internal to external manufacturing. This article examines the driving factors and the author's perspective for what to expect in 2025 and beyond.