Preclinical α-FORMULATION™ Screen
Preclinical α-FORMULATION™ Screen Introduction Preclinical formulation development plays a crucial role in pharmaceutical research, laying the foundation for successful drug discovery and clinical progression. Getting the formulation right early helps mitigate development risks and avoids costly reformulation in later stages. The key factor for formulation success at this early stage is the solubility of a […]
Overcoming Challenges in HPAPI Analysis with Miniaturization
Overcoming Challenges in HPAPI Analysis with Miniaturization Rapid Insights Highly potent active pharmaceutical ingredients (HPAPIs) play a pivotal role in modern drug development, especially in oncology, inflammatory diseases, and antiviral therapeutics where their therapeutic effects at exceptionally low doses bring significant advantages. However, the potency of HPAPIs introduces a challenge for their safe handling, demanding […]
Mitigating Salt Disproportionation Risks
Mitigating Salt Disproportionation Risks Rapid Insights Salt formation is a well-established strategy for increasing the solubility of ionizable drug candidates; however, the possible conversion of salts to their free acid or base forms through disproportionation can have detrimental effects on the stability, manufacturability and regulatory compliance of a drug product by causing variability in drug […]
Jumpstarting Formulation Development
Jumpstarting Formulation Development Rapid Insights Many formulators we speak with rank time pressure as the primary challenge in their programs. The main barriers often cited include the limited amount of available compound for initial formulation screening, filling in information gaps related to the API, and the complex analytical methods required for this initial data collection. […]
An Optimized Workflow for Simplifying Purification and Maximizing Efficiency in Chemistry Scale-Up
The Data Package You Wish You Had but Don’t Have Time to Collect Rapid Insights An impurity formed during a chemical reaction ultimately needs to be purged. As you aim for simplification, efficiency, and minimizing operations in scaling up the chemistry, this challenge becomes magnified the longer it persists. While optimizing reaction conditions may be […]
Unleashing Bioavailability: A Synergistic Approach for the Race Against Disproportionation
Unleashing Bioavailability: A Synergistic Approach for the Race Against Disproportionation Rapid Insights In our latest joint white paper, we explore a breakthrough strategy to improve the bioavailability of poorly soluble APIs together with Microsize. For those in the pharmaceutical industry, improving the bioavailability of APIs is a critical challenge. We combined two well-established techniques: salt […]
Importance of Solubility in ADC Development
The Critical Role of Solubility in Saving Time and Cost in the Development of Antibody-Drug Conjugates (ADCs) Rapid Insights Antibody-Drug Conjugates (ADCs) combine the specificity of monoclonal antibodies with the potent cytotoxic effects of small molecule drugs. Due to the sophisticated nature of these new modalities, both the challenges and the costs of development are […]
What is ‘True Solubility’?
What is ‘True Solubility’? Rapid Insights While the so-called shake-flask method is considered the industry-standard for measuring accurate solubility, there actually exists no standardized protocol. Attempts by international working groups have been made in the past on consensus recommendations for improving data quality of solubility measurement (1), however, these are generally not well-integrated into company […]
Solubility in Chemical Synthesis Process Scaling
Solubility in Chemical Synthesis Process Scaling Rapid Insights The costs and timelines for production are tied to the complexity of the chemistry and the resources necessary for manufacturing. When advancing an asset by developing the initial chemical synthesis into a scalable process, the arguably biggest impact on reducing costs, complexity, and overall lab operations is […]
Formulate First Time Right
Formulate First Time Right Rapid Insights A recent conversation with an industry veteran highlighted that pharmaceutical R&D costs can increase more than 15-fold and timelines can extend an additional 2 years due to an unanticipated change in formulation strategy. Since this has the potential to derail an entire program or even an entire company, the […]
