Aseptic Filling CDMO Singota Solutions in Bloomington, Indiana discusses Factors in Developing Injectable Drug Placebo Formulations for Pharmaceutical Clinical Trials, in Drug Development (early phase, small batch). Singota specializes in small batch aseptic filler, aseptic manufacturing solutions, cold chain pharmaceutical storage, gmp compliant warehouse, and injectable formulation development.
Sitav Elturan Development

Factors in Developing Injectable Drug Placebo Formulations for Pharmaceutical Clinical Trials

Placebo-controlled trials are pivotal in assessing the efficacy of newly developed medicines, serving as a gold standard in clinical research. When meticulously crafted and executed, these trials offer compelling evidence of a drug's effectiveness. A fundamental aspect contributing to the success of such trials lies in the formulation of placebos…
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Aseptic Filling CDMO Singota Solutions (Bloomington, Indiana) discusses Deliver A Technical Package That Serves On-Time Injectable Project Completion. Singota specializes in small batch aseptic filler, aseptic manufacturing solutions, cold chain pharmaceutical storage, gmp compliant warehouse, and injectable formulation development.
Jacob Wheeler Best Practices

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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Singota Solutions Aseptic Filling CDMO in Bloomington, Indiana, discusses Analysis Paralysis: Navigating Early-Phase Analytical Validation. Singota specializes in small batch aseptic filler, aseptic manufacturing solutions, cold chain pharmaceutical storage, gmp compliant warehouse, and injectable formulation development.
Jacob Wheeler Best Practices, Development, 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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CDMO Singota Solutions (Bloomington, Indiana), a leader in Sterile Aseptic Filling, discusses Strengthen Your IND Submission To The FDA By Conducting Microbial Challenge Studies. Singota specializes in small batch aseptic filler, aseptic manufacturing solutions, cold chain pharmaceutical storage, gmp compliant warehouse, and injectable formulation development.
Michelle Hoover Best Practices, Manufacturing

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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CDMO Singota Solutions (Bloomington, Indiana), a leading Aseptic Filling provider, discusses Expertise And Efficiency In Small-Volume Batch Manufacturing. Singota specializes in small batch aseptic filler, aseptic manufacturing solutions, cold chain pharmaceutical storage, gmp compliant warehouse, and injectable formulation development.
Jacob Wheeler Manufacturing

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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