Specialized Pharmaceutical Services
Over the next decade, we will see the innovators within the pharmaceutical industry develop newer, more complex delivery systems while the generic industry continues to aggressive develop and deliver more cost-effective alternatives. Although most pharmaceutical companies have grown comfortable with the current contract research organization (CRO) landscape with traditional drug development studies, newer technologies will require additional scientific expertise and insight beyond CRO’s capabilities. EAG Laboratories has established ourselves within the technology and biomedical space by developing scientific expertise in difficult analytical measurements, characterizations of complex materials and systems, and a pioneering approach to problem solving.
Our offering to the pharmaceutical industry answers difficult technical questions where a scientific answer is challenging. We offer the following scientific services and studies:
- Deformulation/Reverse Engineering: Our generic customers commonly request our expertise in deformulation of innovator products. Depending on the request, we can quantify each excipient, determine grades of critical chemistries, and examine characteristics of the API (e.g. polymorph, crystal size, etc.). In the past three years, we have deformulated over 140 products of various drug products and delivery systems.
- Particulate Identification: Particulate material commonly shows up in pharmaceutical raw materials, in-process samples, and finished products. Understanding the identity of the species is required to determine root cause and evaluate potential corrective action. We have developed microanalytical methods using a combination of organic characterization and surface analysis techniques to provide insight into the chemistry.
- Materials Characterization: EAG has been contacted by pharmaceutical companies to characterize materials and chemistries where the measurements are challenging. We have developed methods for determining API morphology and properties, polymer chemistry and characteristics, grade determination of excipients, and more.
- Glass Delamination: As biologic therapies continue to be developed, more and more glass vials and packaging is required for storage. For the required testing to evaluate glass delamination. EAG has developed unique surface characterization methods to evaluate glass delamination.
Our customers value the scientific interaction they receive during project scoping and discussion
Would you like to learn more about using Specialized Pharmaceutical Services?
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