Author Profile

		[{"id":55295,"link":"https:\/\/cdmoworld.com\/single-use-systems-extractables-leachables-strategy-cdmo\/","name":"single-use-systems-extractables-leachables-strategy-cdmo","thumbnail":{"url":"https:\/\/cdmoworld.com\/wp-content\/uploads\/2026\/03\/Untitled-design-81.png","alt":"A group of scientists in lab coats and protective gear working together in a modern lab, performing research with test tubes, a microscope, and pipettes."},"title":"Single-Use Systems in Biologics Manufacturing: Extractables\/Leachables Strategy for CDMO","postMeta":[],"author":{"name":"CDMO World","link":"https:\/\/cdmoworld.com\/author\/raismrafiq\/"},"date":"Mar 6, 2026","dateGMT":"2026-03-06 12:24:58","modifiedDate":"2026-03-06 12:24:58","modifiedDateGMT":"2026-03-06 12:24:58","commentCount":"0","commentStatus":"closed","categories":{"coma":"<a href=\"https:\/\/cdmoworld.com\/category\/qa\/\" rel=\"category tag\">Q&A<\/a>","space":"<a href=\"https:\/\/cdmoworld.com\/category\/qa\/\" rel=\"category tag\">Q&A<\/a>"},"taxonomies":{"post_tag":"<a href='https:\/\/cdmoworld.com\/tag\/biologics-manufacturing\/' rel='post_tag'>Biologics Manufacturing<\/a><a href='https:\/\/cdmoworld.com\/tag\/cdmo\/' rel='post_tag'>CDMO<\/a><a href='https:\/\/cdmoworld.com\/tag\/cgmp-compliance\/' rel='post_tag'>cGMP Compliance<\/a><a href='https:\/\/cdmoworld.com\/tag\/regulatory-compliance\/' rel='post_tag'>Regulatory Compliance<\/a><a href='https:\/\/cdmoworld.com\/tag\/tech-transfer\/' rel='post_tag'>Tech Transfer<\/a><a href='https:\/\/cdmoworld.com\/tag\/testing\/' rel='post_tag'>Testing<\/a>","content-type":"<a href='https:\/\/cdmoworld.com\/content-type\/articles\/' rel='content-type'>Articles<\/a>"},"readTime":{"min":8,"sec":12},"status":"publish","excerpt":"Transitioning to Single-Use Systems (SUS) offers speed but introduces chemical risks. This 2,500-word Q&A-style guide provides a comprehensive Extractables and Leachables Strategy for sponsors working with CDMOs. Discover expert tips on risk assessment, USP compliance, and analytical validation to ensure patient safety in biologics manufacturing."},{"id":55294,"link":"https:\/\/cdmoworld.com\/drug-substance-vs-drug-product-comparability-cdmo\/","name":"drug-substance-vs-drug-product-comparability-cdmo","thumbnail":{"url":"https:\/\/cdmoworld.com\/wp-content\/uploads\/2026\/03\/Untitled-design-80.png","alt":"A digital illustration contrasting drug substance and drug product, with vials of blue liquid on the left representing drug substance, and vials with capsules and tablets on the right representing drug products, all set in a futuristic lab environment."},"title":"Drug Substance vs Drug Product Comparability: How CDMO Changes Expand Your Study Scope","postMeta":[],"author":{"name":"CDMO World","link":"https:\/\/cdmoworld.com\/author\/raismrafiq\/"},"date":"Mar 6, 2026","dateGMT":"2026-03-06 12:09:04","modifiedDate":"2026-03-06 12:09:18","modifiedDateGMT":"2026-03-06 12:09:18","commentCount":"0","commentStatus":"closed","categories":{"coma":"<a href=\"https:\/\/cdmoworld.com\/category\/tips\/\" rel=\"category tag\">Tips<\/a>","space":"<a href=\"https:\/\/cdmoworld.com\/category\/tips\/\" rel=\"category tag\">Tips<\/a>"},"taxonomies":{"post_tag":"<a href='https:\/\/cdmoworld.com\/tag\/biologics-manufacturing\/' rel='post_tag'>Biologics Manufacturing<\/a><a href='https:\/\/cdmoworld.com\/tag\/cdmo\/' rel='post_tag'>CDMO<\/a><a href='https:\/\/cdmoworld.com\/tag\/cgmp-compliance\/' rel='post_tag'>cGMP Compliance<\/a><a href='https:\/\/cdmoworld.com\/tag\/regulatory-compliance\/' rel='post_tag'>Regulatory Compliance<\/a><a href='https:\/\/cdmoworld.com\/tag\/tech-transfer\/' rel='post_tag'>Tech Transfer<\/a><a href='https:\/\/cdmoworld.com\/tag\/testing\/' rel='post_tag'>Testing<\/a>","content-type":"<a href='https:\/\/cdmoworld.com\/content-type\/articles\/' rel='content-type'>Articles<\/a>"},"readTime":{"min":7,"sec":11},"status":"publish","excerpt":"Navigating the nuances of Drug Substance vs Drug Product Comparability is vital when switching CDMOs. This 2,500-word guide provides expert tips on expanding your study scope. Learn how manufacturing changes impact analytical bridging and how to build a regulatory-compliant comparability plan that ensures safety for biologics."},{"id":55290,"link":"https:\/\/cdmoworld.com\/plasmid-dna-tech-transfer-cdmo-guide\/","name":"plasmid-dna-tech-transfer-cdmo-guide","thumbnail":{"url":"https:\/\/cdmoworld.com\/wp-content\/uploads\/2026\/03\/Untitled-design-79.png","alt":"A hand holding tweezers is shown cutting DNA strands, symbolizing genetic engineering and plasmid DNA technology transfer in a lab setting."},"title":"Plasmid DNA Tech Transfer to a CDMO: Process, Controls, and Release Testing","postMeta":[],"author":{"name":"CDMO World","link":"https:\/\/cdmoworld.com\/author\/raismrafiq\/"},"date":"Mar 6, 2026","dateGMT":"2026-03-06 11:49:25","modifiedDate":"2026-03-06 11:49:25","modifiedDateGMT":"2026-03-06 11:49:25","commentCount":"0","commentStatus":"closed","categories":{"coma":"<a href=\"https:\/\/cdmoworld.com\/category\/sectors\/technology-transfer\/\" rel=\"category tag\">Technology Transfer<\/a>","space":"<a href=\"https:\/\/cdmoworld.com\/category\/sectors\/technology-transfer\/\" rel=\"category tag\">Technology Transfer<\/a>"},"taxonomies":{"post_tag":"<a href='https:\/\/cdmoworld.com\/tag\/biologics-manufacturing\/' rel='post_tag'>Biologics Manufacturing<\/a><a href='https:\/\/cdmoworld.com\/tag\/bioprocess-development\/' rel='post_tag'>Bioprocess Development<\/a><a href='https:\/\/cdmoworld.com\/tag\/cdmo\/' rel='post_tag'>CDMO<\/a><a href='https:\/\/cdmoworld.com\/tag\/cgmp-compliance\/' rel='post_tag'>cGMP Compliance<\/a><a href='https:\/\/cdmoworld.com\/tag\/regulatory-compliance\/' rel='post_tag'>Regulatory Compliance<\/a><a href='https:\/\/cdmoworld.com\/tag\/tech-transfer\/' rel='post_tag'>Tech Transfer<\/a>","content-type":"<a href='https:\/\/cdmoworld.com\/content-type\/articles\/' rel='content-type'>Articles<\/a>"},"readTime":{"min":8,"sec":36},"status":"publish","excerpt":"Plasmid DNA is the backbone of modern gene therapy and mRNA vaccine production. This 2,500-word technical guide explores the complexities of Plasmid DNA Tech Transfer to a CDMO. We analyze critical process parameters, analytical validation, and release testing requirements to ensure your scale-up meets global regulatory standards."},{"id":55285,"link":"https:\/\/cdmoworld.com\/adventitious-agent-testing-biologics-cdmo-strategy\/","name":"adventitious-agent-testing-biologics-cdmo-strategy","thumbnail":{"url":"https:\/\/cdmoworld.com\/wp-content\/uploads\/2026\/03\/Untitled-design-78.png","alt":"A researcher holding a test tube while examining cancerous cells under a microscope, illustrating biological research and testing in a lab environment."},"title":"Adventitious Agent Testing in Biologics: Building a CDMO Testing Strategy That Regulators Accept","postMeta":[],"author":{"name":"CDMO World","link":"https:\/\/cdmoworld.com\/author\/raismrafiq\/"},"date":"Mar 6, 2026","dateGMT":"2026-03-06 11:32:43","modifiedDate":"2026-03-06 12:11:12","modifiedDateGMT":"2026-03-06 12:11:12","commentCount":"0","commentStatus":"closed","categories":{"coma":"<a href=\"https:\/\/cdmoworld.com\/category\/sectors\/quality-control\/\" rel=\"category tag\">Quality Control<\/a>","space":"<a href=\"https:\/\/cdmoworld.com\/category\/sectors\/quality-control\/\" rel=\"category tag\">Quality Control<\/a>"},"taxonomies":{"post_tag":"<a href='https:\/\/cdmoworld.com\/tag\/adventitious-agent-testing\/' rel='post_tag'>Adventitious Agent Testing<\/a><a href='https:\/\/cdmoworld.com\/tag\/biologics-manufacturing\/' rel='post_tag'>Biologics Manufacturing<\/a><a href='https:\/\/cdmoworld.com\/tag\/cdmo\/' rel='post_tag'>CDMO<\/a><a href='https:\/\/cdmoworld.com\/tag\/cgmp-compliance\/' rel='post_tag'>cGMP Compliance<\/a><a href='https:\/\/cdmoworld.com\/tag\/quality-control\/' rel='post_tag'>Quality Control<\/a><a href='https:\/\/cdmoworld.com\/tag\/regulatory-compliance\/' rel='post_tag'>Regulatory Compliance<\/a>","content-type":"<a href='https:\/\/cdmoworld.com\/content-type\/articles\/' rel='content-type'>Articles<\/a>"},"readTime":{"min":8,"sec":3},"status":"publish","excerpt":"Protecting biologics from viral, bacterial, and fungal contaminants is a regulatory mandate. This 2,500-word guide details Adventitious Agent Testing strategies at CDMOs. Explore in vitro and in vivo assays, Next-Generation Sequencing (NGS) trends, and how to structure your testing program to ensure safety and clinical success."},{"id":55283,"link":"https:\/\/cdmoworld.com\/rapid-mycoplasma-methods-biologics-qc-validation\/","name":"rapid-mycoplasma-methods-biologics-qc-validation","thumbnail":{"url":"https:\/\/cdmoworld.com\/wp-content\/uploads\/2026\/03\/Untitled-design-77.png","alt":"A lab technician in blue gloves adds a droplet to a Petri dish containing glowing mycoplasma colonies, while test tubes are prepared in the background in a modern laboratory setup."},"title":"Rapid Mycoplasma Methods in Biologics QC: When CDMOs Can Use Them and How to Validate","postMeta":[],"author":{"name":"CDMO World","link":"https:\/\/cdmoworld.com\/author\/raismrafiq\/"},"date":"Mar 6, 2026","dateGMT":"2026-03-06 11:12:20","modifiedDate":"2026-03-06 11:12:21","modifiedDateGMT":"2026-03-06 11:12:21","commentCount":"0","commentStatus":"closed","categories":{"coma":"<a href=\"https:\/\/cdmoworld.com\/category\/features\/columns\/testing-matters\/\" rel=\"category tag\">Testing Matters<\/a>","space":"<a href=\"https:\/\/cdmoworld.com\/category\/features\/columns\/testing-matters\/\" rel=\"category tag\">Testing Matters<\/a>"},"taxonomies":{"post_tag":"<a href='https:\/\/cdmoworld.com\/tag\/biologics-manufacturing\/' rel='post_tag'>Biologics Manufacturing<\/a><a href='https:\/\/cdmoworld.com\/tag\/cdmo\/' rel='post_tag'>CDMO<\/a><a href='https:\/\/cdmoworld.com\/tag\/cgmp-compliance\/' rel='post_tag'>cGMP Compliance<\/a><a href='https:\/\/cdmoworld.com\/tag\/quality-control\/' rel='post_tag'>Quality Control<\/a><a href='https:\/\/cdmoworld.com\/tag\/regulatory-compliance\/' rel='post_tag'>Regulatory Compliance<\/a><a href='https:\/\/cdmoworld.com\/tag\/testing\/' rel='post_tag'>Testing<\/a>","content-type":"<a href='https:\/\/cdmoworld.com\/content-type\/articles\/' rel='content-type'>Articles<\/a>"},"readTime":{"min":7,"sec":52},"status":"publish","excerpt":"Traditional mycoplasma testing takes 28 days, delaying critical patient therapies. This 2,500-word guide explores Rapid Mycoplasma Methods, detailing when CDMOs can implement them and the rigorous validation steps required to satisfy global regulators. Learn how to accelerate your biologics QC without compromising safety or compliance."}]