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Areta's speech at CPA training course

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Published on Friday, 16 December 2011 13:14

December 14th, Areta was invited to give a speech in the occasion of the CPA (Chemical Pharmaceutical generic Association) training course on "Development and Production of APIs", held in Milan.

Dr. Luca Romagnoli presented an overview of the ICH Q5 guidelines, related to the process development and the key quality aspects to be addressed when manufacturing biological drugs. The requirements for the cell banking systems, the validation of the viral removal processes, the quality controls of the DNA constructs and the host cell lines were discussed, presenting case studies covering the major biological drug classes such as recombinant proteins and monoclonal antibodies.

Finally, the advantages of single-use solutions for high-quality biodrugs manufacturing were described, as well as the possibility to exploit their characteristics to build robust and cost-effective processes.

Since 2002, CPA represents over 30 companies of the chemical and pharmaceutical Italian industry. The Association promotes the collective interest of the stakeholders by fostering the interaction with the regulatory bodies, organizing cultural activities and offering training courses, along with editorial activity and consultancy for the Associates. CPA is part of the European Fine Chemicals Group (CEFIC).