Guest Columns
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Zero-Acceptance Sampling Can Protect Your Next Data Migration
12/13/2024
When migrating data in a GMP setting, verifying every record is impossible. A well-structured sampling approach can mitigate the risks and help with a smooth transition.
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Survey Findings: How Are IDMP Readiness Efforts Progressing?
12/13/2024
ISO Identification of Medicinal Products (IDMP) standards were designed to harmonize the way the life sciences industry records and manages data about its products. Companies’ state of readiness to implement and harness IDMP still varies.
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Cell Culture Trends To Watch In 2025
12/12/2024
Three upstream processing experts weigh in on advancements from the past year and what they're looking forward to in the year ahead.
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FDA Issues New Guidance: Nonclinical Safety Assessment Of Oligonucleotide-Based Therapeutics
12/11/2024
FDA's CDER recently issued a draft guidance: Nonclinical Safety Assessment of Oligonucleotide-Based Therapeutics. This article provides a summary and analysis. The public comment period ends January 14, 2025.
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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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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.
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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.
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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.
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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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How Atsena Got Its Gene Therapy To Spread Subretinally To Treat XLRS
12/6/2024
The company’s novel capsid, part of a Phase 1/2 trial, is delivering therapeutic genes to the fovea without the need for detaching part of the retina.