Eric Graban Best Practices, Development, Industry, Innovation, Manufacturing, Production

Specializing In Small And Early-Stage Injectables, Not Just Small Batches

Source: Singota Solutions By Jennifer Gray and Eric Graban, Singota Solutions For small and/or early stage pharmaceutical companies trying to advance a small-volume drug product through preclinical and clinical trials, the temptation to partner with large, well-known CDMOs for aseptic manufacturing can be alluring. Their reputation as service providers for large…
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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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sample scoop active
Jacob Wheeler Development, Industry, Innovation

How A Sample/Dispense Service Streamlines Drug Development

Source: Singota Solutions By Alice Levis, Singota Solutions Biopharma organizations often require aliquoting of materials to support their projects, but can be burdened by the timelines, costs, and risk of compromising materials. Not all contract development and manufacturing organizations (CDMOs) have the capability to aliquot clients' material via sample (non-GMP…
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cold chain
Jacob Wheeler Development, Industry, Innovation, Supply Chain Management

Evaluation And Management Of Vendor-Qualified Thermal Solutions

Source: Singota Solutions By Travis Hudson, Singota Solutions Evaluating vendor qualification of thermal solutions is not an indictment of the vendor; it is due diligence in an industry where risk guides nearly all decision-making, as well as many regulatory mandates. Usage of a system can be justified based on a vendor’s qualification…
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