Microbiology Fulfills A Vital QC Role At A CDMO In Aseptic Filling And Sampling

In the dynamic landscape of pharmaceutical manufacturing, where precision and compliance are paramount, every step in the process plays a critical role in ensuring product efficacy and safety. From the meticulous development of injectable formulations to the stringent requirements of cold chain pharmaceutical storage, each phase demands meticulous attention to…

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…

Factors in Developing Injectable Drug Placebo Formulations for Pharmaceutical Clinical Trials

In the dynamic landscape of pharmaceutical research, the significance of placebo-controlled trials as a litmus test for evaluating the efficacy of emerging medications cannot be overstated. However, the efficacy of such trials hinges upon a meticulous understanding and implementation of placebo development practices. This article from Singota Solutions (Bloomington, Indiana…

Expanding Project Leadership Through PMP Certification

Amidst the intricate landscape of pharmaceutical development, where precision and adherence to regulatory standards are paramount, the integration of aseptic manufacturing solutions and meticulous project management becomes indispensable. From small batch aseptic filler operations to cold chain pharmaceutical storage in a GMP compliant warehouse, every aspect of injectable formulation development…

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…

Characterizing Novel Microparticle Encapsulated Drug Formulations – Part 2

As the demand for targeted and controlled release therapies continues to rise, microparticle encapsulated drugs emerge as increasingly desirable dosage forms among clinicians. In this second part of our series, we delve deeper into the intricate process of injectable formulation development, focusing on the crucial task of characterizing and understanding…

Approach To Simplifying Aseptic Contract Manufacturing – Part 2: Documentation

In our ongoing exploration of aseptic manufacturing solutions, this second installment delves deeper into the operational efficiencies brought forth by the Cytiva SA25 Aseptic Filling Workcell, utilized by Singota Solutions (the very first in North America to employ the SA25). This installment focuses on how this state-of-the-art small batch aseptic…

Approach To Simplifying Aseptic Contract Manufacturing

Navigating the intricacies of pharmaceutical and biologic clinical trials demands agile supply chain management, especially when facing sudden demands for clinical drug product. In this inaugural piece of our series, we delve into the pivotal role of Contract Development and Manufacturing Organizations like Singota Solutions (Bloomington, Indiana CDMO) in meeting…

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