How Efficient Batch Records Serve Thorough Tech Transfer — Optimizing Aseptic Fill For Development Projects

As the pharmaceutical industry continues to advance, the need for efficient and effective technology transfer processes becomes increasingly crucial. From small batch aseptic filler, to cold chain pharmaceutical storage, companies are constantly seeking aseptic manufacturing solutions, preferably with GMP compliant warehouse facilities, to streamline injectable formulation development. However, the intricate…

Developmental Testing Of IV Solutions

Intravenous (IV) drug administration has expanded as proteins — versus the small-molecule drug products that formerly dominated — have become increasingly complicated, interacting with the body more quickly and targeting therapeutic areas more precisely. To avoid adverse effects to patients, some drugs must be diluted and administered slowly using IV…

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

Navigating a complex landscape, small pharmaceutical firms seek aseptic manufacturing solutions that cater to their specific needs. This is where Singota Solutions (Bloomington, Indiana CDMO) steps in, offering expertise in small batch aseptic filler technologies and specialized capabilities in injectable formulation development. With a focus on bridging the gap for…

Transitioning From Academic Research To Pharmaceutical Industry Drug Formulation And Analytical Development

Embarking on a career transition from academic research to industry demands a nuanced understanding of the diverse demands and objectives shaping each realm. At Singota Solutions (Bloomington, Indiana CDMO), we recognize the challenges and opportunities inherent in this shift, particularly in the realm of injectable formulation development. In this article,…

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…

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.…