Jacob Wheeler Best Practices, Development, Industry, Innovation, Manufacturing, Production

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

Source: Singota SolutionsBy Jennifer Gray and Eric Graban, Singota SolutionsFor small and/or earlier-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 pharmaceutical companies, along with their…
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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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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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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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