Innovative Formulation Development Services
Comprehensive Formulation Development and Optimization
Our Formulation Development services focus on creating stable, effective, and scalable pharmaceutical formulations to meet the diverse needs of drug development. We specialize in optimizing formulations for improved performance, scalability, and regulatory compliance.
Lipid Screening
Lipid-based delivery systems are crucial in modern drug development, particularly for complex molecules like nucleic acids and peptides. Our Lipid Screening services enable us to identify the ideal lipid compositions for your drug. Through systematic screening, we select the lipid formulations that offer optimal stability, bioavailability, and efficiency. Whether for liposomes, lipid nanoparticles, or emulsions, this step is essential for ensuring the successful delivery of active pharmaceutical ingredients (APIs).
Nucleic Acid Cargo Integrity
For drugs that involve nucleic acids—such as DNA, RNA, or siRNA—preserving the integrity of the nucleic acid cargo is paramount. Our Nucleic Acid Cargo Integrity assessment ensures that the genetic material remains intact and effective throughout the formulation process. By using cutting-edge analytical methods, we evaluate the stability of the nucleic acids, helping to mitigate the risks of degradation and ensuring that the therapeutic payload reaches its target site without compromise.
Particle Size and Size Distribution
The size and distribution of particles within a formulation can significantly affect its performance, especially in terms of absorption and delivery efficiency. Our Particle Size and Size Distribution services provide precise control over the size of nanoparticles, microparticles, or other carriers. This is particularly important in enhancing the bioavailability of poorly soluble drugs, controlling drug release, and ensuring consistency across batches. Our advanced technologies allow for thorough characterization, ensuring that particle sizes are optimized for maximum efficacy.
Lipid Quantitation
Quantifying the lipids within a formulation is essential for maintaining product consistency, efficacy, and regulatory compliance. Our Lipid Quantitation services employ sophisticated analytical methods to accurately measure the lipid content in your formulation. By ensuring precise lipid levels, we help guarantee the stability of lipid-based formulations and support regulatory submissions by providing detailed lipid profiles.
Formulation Optimization
Formulation is an iterative process, requiring continuous refinement to achieve the desired therapeutic outcomes. Our Formulation Optimization services focus on improving key aspects such as solubility, bioavailability, stability, and the overall performance of your product. By working closely with your development team, we systematically enhance the formulation, ensuring it meets both commercial and clinical needs, while also preparing it for large-scale production.
Scale-Up and Process Development
Scaling up a formulation from lab-scale to commercial production is a complex task. Our Scale-Up and Process Development services ensure that your formulation can be successfully transitioned to large-scale manufacturing without losing its integrity or effectiveness. We optimize the production process to be both efficient and reproducible, minimizing potential issues during scale-up while maintaining product quality.
Excipient Compatibility
Excipient selection and compatibility are crucial factors in formulation success. In our Excipient Compatibility studies, we evaluate how inactive ingredients interact with the API and each other. This step is critical to ensure that excipients do not negatively impact the stability, solubility, or bioavailability of the drug. Our thorough testing process helps to identify the best combination of excipients to support the drug’s performance and longevity.
Solubility Screening
The solubility of an API can greatly impact its bioavailability and therapeutic effectiveness. Our Solubility Screening services evaluate various formulations and excipient combinations to enhance the solubility of poorly water-soluble drugs. By identifying solubility-enhancing techniques and materials, we ensure that your drug can be delivered in a bioavailable form, improving patient outcomes.
Early Development
Our Early Development services help you navigate the initial stages of drug formulation. We offer formulation support from preclinical research through early clinical development, addressing challenges such as stability, solubility, and scalability. By taking a proactive approach during the early development phase, we help set the stage for future success, ensuring that the formulation is robust and ready for clinical trials.
Stability Studies
Understanding how a formulation behaves over time is a key aspect of drug development. Our Stability Studies are designed to assess the long-term stability of formulations under various environmental conditions, such as temperature, humidity, and light. We conduct these studies in compliance with ICH guidelines, ensuring that your product maintains its potency, safety, and efficacy throughout its shelf life. Our stability studies are also vital for supporting regulatory submissions and determining optimal storage conditions.
Aggregation Studies
For biologics and complex drug formulations, aggregation can pose significant stability risks. Our Aggregation Studies identify the conditions that may lead to molecular aggregation, which can affect the safety and efficacy of the drug. We use state-of-the-art techniques to monitor and prevent aggregation, helping to ensure that the formulation remains stable and effective over time.
Force Degradation Studies
In Force Degradation Studies, we expose formulations to accelerated stress conditions, such as extreme pH, temperature, and humidity, to simulate potential degradation pathways. These studies provide insight into the formulation’s stability and help in understanding how it might break down under adverse conditions. The results are used to improve formulation robustness and support regulatory submissions by providing evidence of the drug’s stability profile.
Batch Manufacture for IND Enabling Studies
To support Investigational New Drug (IND) applications, we offer Batch Manufacture for IND Enabling Studies. We produce high-quality, GMP-compliant batches that are essential for toxicology and clinical studies. This ensures that your formulation meets the stringent quality requirements necessary for regulatory approval and progression to clinical trials.
GMP Manufacturing to Support Phase 1/2 Clinical Studies
In late 2024, we will offer GMP Manufacturing to Support Phase 1/2 Clinical Studies, providing large-scale manufacturing capabilities under Good Manufacturing Practice (GMP) standards. This expansion will allow us to support early-phase clinical trials, ensuring that your formulation is produced to the highest quality standards and is ready for human testing.
Thermal Cycling and Freeze-Thaw Studies
Temperature fluctuations during storage or transport can affect a drug’s stability. Our Thermal Cycling and Freeze-Thaw Studies assess how formulations react to cycles of freezing and thawing or exposure to varying temperatures. This ensures that the drug maintains its integrity and efficacy even when subjected to challenging environmental conditions, providing valuable data for stability and transport guidelines.
