Carlos Celma Lezcano

Title: Succeed in the batch testing for release of biosimilars in the European community
Time: 10:00 - 10:45

Biography

Carles Celma obtained his graduate and PhD in Organic Chemistry at the University of Barcelona. He has more than 25 years in the phamabiotech industry and since 2012 is the Scientific Director of Biologics at Kymos Pharma Services, a CRO located in Barcelona that give support to phama and biotech companies both in CMO and bioanalysis of biologics and small molecules. He has wide experience in method development, validation and sample analysis using physicochemical, binding and cellular methods for regulated analysis. He has more than 40 communications to congresses and 15 publications in different international journals

Research Interest


Abstract

The European Community is a highly attractive marked for biosimilar companies due to the high degree of coverage of the heath of its citizens by the governments of the country members. Patient treatments by biopharmaceutical drugs are increasing dramatically due to their efficacy in many life-threatening diseases. Due to the high cost of such treatments the European Medicament Agency has clearly opted for biosimilars as a way of reducing the cost of this type of treatments. Several companies that manufacture their biosimilars both inside and outside the EC are commercializing their products in the EC and is expected that in the future this number will increase.

Because the European pharmaceutical market is highly regulated to assure the efficacy and safety on the drugs commercialized in this area, several conditions must be accomplished before these drugs reach to the patients. One of these conditions for companies that manufacture their products outside the EC that are not under mutual recognition agreements is that all batches must be re-tested by a GMP compliant European laboratory to double check that such batches accomplishes the specifications approved in the dossier.

A deep and well documented Analytical Methods Transfer (AMT) procedure must be carried out between the originator laboratory and the receiving laboratory to assure a smooth and effective testing of the commercial batches avoiding delays and false out of specification results in the commercialization phase of the biosimilar.

Several guidelines and recommendations have been published to describe how to do this process. Although companies are working to harmonize the AMT, nowadays several strategies to perform these activities are used. 

In this communication we describe our approach of AMT that is aligned to the current guidelines and allows to acquire a deep understanding of the more complicated in-house analytical methods. The schema of below shows the AMT for one biosimilar to illustrate this approach.