Analytical Services

Leveraging comprehensive analytical development services like those offered by Ascendia Pharmaceutical Solutions can help drug development teams address numerous challenges they face during formulation development.

Ascendia offers its pharma and biologics clients complete analytical development services to support formulation development. Our services are offered under cGMP and non-GMP conditions.

Methodology:

Key to Obtaining Quality Results

One all-too-common challenge in the pharma industry is a client’s need for robust analytical methods. Developing accurate and reliable methods for assessing formulations' physical and chemical properties is crucial to ensure product quality and regulatory compliance.

By utilizing state-of-the-art equipment, such as HPLC, UPLC, GC, LCMS, FTIR, and others, along with experienced scientists, Ascendia can help drug development teams overcome the hurdle of method development and validation.

Gaining Insight via Comprehensive Techniques

Another significant challenge lies in characterizing complex formulations thoroughly. Companies gain comprehensive insights into their formulations with the diverse range of analytical techniques available — including assay determination, impurity identification and quantification, and content uniformity testing.

Using these analytical processes and our expertise in analytical method development, Ascendia fully characterizes the physical/chemical properties of liquid and solid drug formulations, including forced degradation and impurity identification.

This meticulous depth of understanding is essential for optimizing formulation processes. It helps identify potential impurities and ensures product stability over time.

The Widespread Need for Analytical Expertise

Over the past few decades, analytical sciences have grown by leaps and bounds. Today, you'd be hard-pressed to find a field unaffected by modern analysis technology. Analytical techniques allow pharmaceutical companies to ensure their products' quality, safety, and efficacy. They can detect impurities, verify active ingredient concentration, and assess formulations' stability over time.

In short, analytical sciences empower researchers, scientists, and professionals to address complex challenges. They help drug development teams make informed decisions and drive innovation across diverse fields and industries. Analytical techniques are crucial in advancing knowledge and improving our quality of life by ensuring product quality and safety.

Harnessing the Ascendia Approach

At Ascendia, we provide analytical methods development, validation, and testing support using state-of-the-art equipment.

Our areas of expertise include HPLC, UPLC, GC, LCMS, FTIR, Karl-Fischer, Differential Scanning Calorimetry (DSC), and Dissolution. Depending on the formulation approach, Ascendia scientists employ different analytical techniques to characterize the formulation.

Spotting Stability Issues Early On

Additionally, Ascendia’s ability to perform in-depth analysis — such as forced degradation studies and solid-state characterization — addresses the challenge of predicting and mitigating potential degradation pathways and stability issues.

By identifying degradation products and understanding their impact on product efficacy and safety, Ascendia clients can make informed decisions throughout the drug development process.

Moreover, accurate and reproducible dissolution testing and determination of properties is a critical challenge in formulation development. By leveraging our expertise and services, pharma and biologics companies can ensure that their products meet regulatory requirements and perform as intended upon administration.

Client-First

Our Commitment to Taking a Client-First Approach

Companies can address challenges related to method development, formulation characterization, stability assessment, and regulatory compliance by tapping into comprehensive analytical development services.

Ascendia's services enable companies to make informed decisions, optimize formulations, and ultimately bring high-quality drug products to market efficiently and effectively. Contact Ascendia today for an initial consultation on your project.