Jacob Wheeler Development, Manufacturing, Quality Assurance, Testing

Analysis Paralysis: Navigating Early-Phase Analytical Validation

Source: Singota Solutions By Dustin Lafferty, Singota Solutions Significant confusion persists across the pharmaceutical/biopharmaceutical industry relevant to early-phase analytical development and validation. While several guidance documents serve as a de facto standard, distinguishing method validation requirements from suggestions, when and how to apply those guidelines often is not a straightforward task.…
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Jacob Wheeler Manufacturing, Quality Assurance, Testing

Deliver A Technical Package That Serves On-Time Injectable Project Completion

Source: Singota Solutions By William Powers, Singota Solutions Meeting drug development timelines — in particular, filling the first Phase 1 batch for an injectable’s clinical trial – is critical. Producing that initial batch requires the CDMO to gather information from a pharmaceutical client about its drug substance, drug product, and analytical…
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Site Admin Quality Assurance, Testing

Which Testing Does An Effective Certificate Of Analysis Include?

Source: Singota Solutions By Ken Chomistek, Singota Solutions Compendial monograph (pharmacopeial) testing applied to pharmaceutical raw materials and finished drug products is a critical element of drug development. A testing record is created in the form of a Certificate of Analysis (CoA) for manufacturing release and distribution. However, the testing required…
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Michelle Hoover Industry, Manufacturing, Quality Assurance, Testing

Strengthen Your IND Submission To The FDA By Conducting Microbial Challenge Studies

Strengthen Your IND Submission To The FDA By Conducting Microbial Challenge Studies Source: Singota Solutions By Ken Chomistek, Singota Solutions Microbial challenge studies are becoming increasingly common as drug products (DP) are being manufactured with different types of active pharmaceutical ingredients (API) than fifteen years ago. Peptides, proteins, monoclonal antibodies, oligonucleotides,…
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Jacob Wheeler Industry, Manufacturing, Quality Assurance

Expertise And Efficiency In Small-Volume Batch Manufacturing

Expertise And Efficiency In Small-Volume Batch Manufacturing Source: Singota Solutions By Alex Cravens, Singota Solutions Demand for small-batch drug product (DP) manufacturing — from formulation to sterile fill/finish — is rising as drugs for precision medicine and large-molecule biologics gain in prominence. However, traditional fill/finish providers may consider small batch sizes…
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