The Advantages Of A Cross-Functional Staff Model In Pharmaceutical Manufacturing

In the world of pharmaceutical manufacturing, Singota Solutions (Bloomington, Indiana CDMO) stands out by leveraging a cross-functional staffing model that spans sampling/dispensing, formulation, filling, and finishing. This approach is complemented by our small batch aseptic filler and comprehensive aseptic manufacturing solutions (including aseptic filling). Employees are cross-trained, allowing them to…

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…

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…

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…

Challenges and Solutions in Biologic Therapies Product Manufacturing

In the intricate realm of injectable formulation development, crafting effective solutions for biologic therapies demands meticulous attention to detail and innovative approaches. Unlike conventional small molecule products, biologics necessitate specialized small batch aseptic filler techniques (Singota Solution's specialty) tailored to their unique properties and parenteral administration requirements. Formulation scientists and…

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…

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,…

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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