#USA #West Lafayette #Patent Services #Improved Pharma #X-Ray Diffraction

Improved Pharma Introduces Enhanced Solid-State Characterization Services

Improved Pharma is taking a significant step forward in the pharmaceutical landscape by announcing the expansion of its solid-state characterization services. This enhancement includes advanced X-ray diffraction and expert data interpretation, aimed squarely at meeting the growing industry demand for precise regulatory submission and patent approval processes. With an emphasis on high-quality data, Improved Pharma's new offering is positioned to help clients navigate increasingly complex challenges in small-molecule development.

Meeting Industry Challenges

As the pharmaceutical industry evolves, developers often encounter difficulties with poorly crystalline, nanocrystalline, or disordered materials. In response, Improved Pharma has tailored its services to deliver scientifically robust interpretations that are defensible in the face of rigorous regulatory scrutiny. The company's integration of advanced X-ray diffraction techniques allows for the meticulous identification of crystal forms and detection of trace phases, critical components that standard laboratory practices may overlook.

One of the distinguishing features of Improved Pharma's services is its collaboration with Argonne National Laboratory, which facilitates high-resolution synchrotron and pair distribution function (PDF) analyses. These collaborations provide clients with superior characterization capabilities that are essential for both regulatory submissions and patent applications, ensuring high confidence in the quality of their drug products.

The Enhanced Service Team

Leading the charge in this endeavor is a team of esteemed experts, including Dr. Stephen Byrn and staff crystallographer Dr. Jared Smit. Their expertise reinforces the company's commitment to high-performance and rigorous scientific methodologies. Dr. Byrn emphasized the importance of solid-state characterization in defining the manufacturable form of a drug substance, stating, “In today's pharmaceutical landscape, solid-state characterization is vital for regulatory submissions and patents.”

Moreover, Dr. Pamela Smith, COO of Improved Pharma, highlighted the operational excellence that is being integrated into this service expansion. By harnessing advanced tools like synchrotron sources and PDF analysis, the service offers a unique level of support that is often absent in conventional outsourcing models. According to Dr. Smith, “Operational excellence and superior data are at the heart of our service expansion.”

Key Features of the New Offerings

The service expansion brings several key features:

• - Comprehensive Data Acquisition and Interpretation

Utilizing high-performance PXRD and single-crystal diffraction (SCXRD) techniques allows for the collection of extensive data required for precise analysis.

• - Synchrotron Access and Trace Phase Detection

The partnership with Argonne's Advanced Photon Source offers high-resolution XRPD, enabling the identification of trace phases and enhanced characterization of nanocrystalline substances.

• - PDF Analysis

This feature distinguishes amorphous materials from poorly crystalline states, providing clarity in the identification process.

• - Orthogonal Data Integration

By corroborating PXRD data with techniques like Raman mapping, solid-state NMR, and thermal analysis, Improved Pharma offers a multi-layered approach to data validation.

• - Regulatory and Patent Support

The data packages created are specifically designed to meet the criteria for Chemistry, Manufacturing, and Controls (CMC) submissions and support patent review.

About Improved Pharma

Founded in 2006 by Stephen and Sarah Byrn, Improved Pharma specializes in research, consulting, and information services tailored to the pharmaceutical industry. Their offerings encompass solid-state form studies, formulation design, synchrotron techniques, analytical testing, and expert consulting. As the industry continues to grapple with complex development demands, Improved Pharma is positioned to be a cornerstone in providing scientific clarity and accuracy.

For those seeking to enhance their pharmaceutical research and development efforts, Improved Pharma is a trusted partner. For further details, visit Improved Pharma's website.