A successful biopharmaceutical product depends on a comprehensive and well-designed analytical program.  Whether it is to support process development, formulation development or quality control, strong analytical capabilities is the key to the advancement of your biologics product into the clinic and beyond.

ANALYTICAL PROGRAM DESIGN

Althea’s analytical scientists approach analytical program design with the mindset that every product is unique, and multiple methods are necessary to characterize your product.  Therefore, clients receive customized, one-of-a-kind programs that integrate CMC-related analytical services and solutions.  At any point in your drug development cycle, we will provide the appropriate level of analytical capability and product understanding for your drug product.  Our team’s experience and flexibility in phase appropriate development leads to timely and efficient drug development.

EXPERIENCE

Althea employs a seasoned team of analytical scientists with proven track records in the biopharmaceutical industry. Our scientists have pioneered new applications of biochemical and biophysical analyses to the characterization of protein drugs. The concept of “Well Characterized Biological” was developed by our leaders with the FDA in order to raise the bar on biologics characterization. Over the last 30 years, our analytics group has shown a successful track record of working closely with regulatory agencies world-wide and been involved with successful submissions of dozens of regulatory filings. Our team of scientists has a record of commercial product successes including: Epogen®, Denosumab®, Neulasta®, Neupogen®, Byetta®, Symlin®, Protropin®, and Kepivance®.

COMMUNICATION

It is important to Althea that all analytical method development data is shared with the client.  That is why Althea provides reports to clients on a regular basis.  Not only do we share real-time, raw data for clients to review at any point of the project, we also welcome open dialogue and technical discussions with clients. With transparency and open communication, we can establish synergistic relationships with our clients that lead to faster and better decisions to guide their drug development.

PROJECT MANAGEMENT & BUSINESS PROCESS
Working with you from start to finish.

QUALITY & REGULATORY
Taking pride in our history of quality.

Case Study

Monoclonal Antibody Characterization & Testing

• Peptide map by LC-MS for release and stability
• Peptide map by LC-MS-MS for sequence confirmation
• Size exclusion chromatography with multi angle light scattering
• Ion exchange chromatography
• SDS-PAGE, reducing and non-reducing
• ELISA
• Particle analysis using Microscopic Flow Imaging
• Capillary Isoelectric Focusing (cIEF)
• Mass Spectrometry (QTOF)
• Glycan Analysis