Systematic Approach To Early Phase Sterile Drug Product Technology Transfer

Initial scale-up of a sterile drug product manufacturing process (early phase) can present significant challenges and risks to new drug development timelines, budgets, product quality, and patient safety if not properly managed. At Singota Solutions (Bloomington, Indiana CDMO), our expertise in injectable formulation development, combined with our advanced aseptic manufacturing…

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…

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

Source: Singota Solutions Navigating the complex landscape of pharmaceutical development (Injectables), particularly for small and early-stage companies, demands careful consideration of manufacturing partnerships. While large CDMOs may seem like obvious choices, their focus on high-volume production often leaves smaller projects sidelined. This shift is notable in the context of the industry's…

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…

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.…