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
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
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.