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Newsletter  |  September 2014

Dedicated Individual Service - Unique Full Service Provider Focused on Early Stage Clinical Research

Science Exchange Symposium

Biologics & Biosimilars: Key Considerations & Strategies in Early Stage Development

Join us in Cambridge, Massachusetts on October 16th from 4:30 p.m. to 6:40 p.m.!

This complimentary Science Exchange Symposium is a great opportunity for members of the New England Pharmaceutical and Biopharmaceutical communities to share ideas on manufacturing, drug development and biomedical research.

The Symposium will include presentations from industry experts on early phase drug development from discovery, clinical and bioanalytical perspectives.

View topics and register

Overcoming the Bioanalysis Challenges of Biosimilars:
Rituximab Case Study

As Biosimilar compounds are not exact duplicates of Innovator Biotherapeutics, the Regulatory Agency requirements differ from those of small molecules. One important difference is the required evaluation of "similarity" of the Biosimilar compared to the innovator Biologic compound.

Bioanalysis of Biosimilar compounds is subject to endogenous interference, requiring specific and selective assay to ensure data reliability. The specificity and selectivity of traditional quantification approaches (Ligand Binding Assays - LBA) are dependent on the interaction of critical reagents to the Biotherapeutic. It is possible that the Innovator and the Biosimilar do not have the same binding characteristics towards the assay critical reagents. In this case, two assays with different critical reagents may be needed and the demonstration of biocomparability may be more complicated.

LCMS and more recently HRMS have been gaining momentum as an important alternative for the Bioanalysis of Biotherapeutics. Unlike traditional approaches, LCMS assays can be developed for Biosimilar Bioanalysis without using critical reagents and therefore only a single LCMS assay is needed for both Biosimilar and Innovator comparison. Algorithme Pharma has recently demonstrated the applicability of this approach in a case study on the application of HRMS in the Quantification of Rituximab.

To view the case study Webinar, click here

image of Dr. Fabio Garofolo

For a poster reprint of the Rituximab Case Study, click here


Bioanalysis Journal:
Special Focus Issue

Bioanalysis of Large Molecules by LC-MS
Faye Vazvaei, Fabio Garofolo
Bioanalysis, 2014, 6 (13), Pages 1727-1729.

Application of High-Resolution MS in the Quantification of a Therapeutic Monoclonal Antibody in Human Plasma
Kevork Mekhssian, Jean-Nicholas Mess, Fabio Garofolo
Bioanalysis, 2014, 6 (13), Pages 1767-1779.

ACCP Conference:

Discovering the Latest in Clinical Pharmacology Innovations, in Atlanta GA. Our Poster Presentation included:

Single-Dose Pharmacokinetics of Deferiprone in Subjects with Various Degrees of Renal Impairment

To request information »


Join us for the 17th Annual Symposium: Clinical and Pharmaceutical Solutions through Analysis.

Our Poster Presentation will include:

Assessment of the ionKey/MSTM Technology to Reach Ultra High Level of Sensitivity for Bioanalysis Quantification of Large Molecules in Plasma

To request information »

Request to Meet Us

8th Pain Therapeutics Summit
September 24-25, 2014
Boston, MA

September 29-October 2, 2014
Langhorne, PA

Outsourcing Clinical Trials, New England
October 7-8, 2014
Cambridge, MA

ICSE / CPhI Worldwide
October 7-9, 2014
Paris Nord Villepinte, France

Visit us in Hall 1, Stand 1G53

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For more information, please contact us at:
1 (450) 973-6077
1 (888) 267-7449 View our Poster Podcast on Youtube View our Linkedin Channel