Technology Transfer in Biopharma Process and Operations

Technology Transfer in Biopharma Process and Operations

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(6 November 2018, Milan, Italy)

BSP Pharmaceuticals S.p.A. is proud to announce Its participation to the Technology Transfer in Biopharma Process and Operation at Milan, next 6th of November 2018 organized by The PDA Italy Chapter.

The Parenteral Drug Association (PDA) is a non-profit organization founded in the United States in 1946 and spread in several countries around the world in parallel with the development of the pharmaceutical industry.It currently has over 10,000 members, mainly from the pharmaceutical and biotechnology industry and its related industries, but increasingly members of the academic world and regulatory agencies. The PDA Italy Chapter, is the Italian section of the association founded in 2000; this proposes to apply the aims and the mission of the Association in the reality of the Italian pharmaceutical industry, with all its peculiarities, without losing sight of the international standard that is proper to it.In the last years the pharma Italian companies have been heavily involved in transferring new drugs manufacturing in and out from their facilities. The increase of CDMOs and CMOs business and strategic changes in the pharmaceutical world like mergeries and acquisitions increase the necessity to transfer productions from one site to another making the technology transfer one of the hottest topics of pharmaceutical production! A series of challenges are linked to technology transfers like:

  • Establish a productive relationship with the donor site, respecting their timeline and mitigating their requests
  • Discuss and coordinate all suppliers involved
  • Use the current production capabilities to develop new processes and manufacture validation lots without affecting the site commercial capacity
  • Evaluate risks in case process changes are required
  • Assure no contamination and robust cleaning procedures with respect to commercial products manufacturing

For all these reasons PDA Italy Chapter gas organized this full day congress plus panel discussion with International Speakers and Exhibitor on the following topics on Technology Transfer:

  • Risk management and risk-based GMP
  • Technology Transfer
  • Quality management systems for Pharmaceuticals
  • Industry case studies - compliance and quality issues

Save the Date!!! Next November 6, 2018 from 13:45 to 14:30, Maria Elena Guadagno – Business Director of BSP – will presents the speech ‘Technology Transfer of an ADC (Antibody Drug Conjugated) products: from Conjugation to Fill-Finish’.