A new state-of-the-art facility dedicated to plasmid manufacturing will be in operation by August 2019 in Gerenzano, Italy. The new site will couple with the existing GMP facility active in the Cell and Gene (C&G) therapy space. With 800m2 (8,000 square feet) of cleanrooms, the two facilities of Anemocyte, the first Biotech Manufacturing Organisation (BMO), will address manufacturing needs of Somatic Cells, Non-Viral Modified Cells, Vesicles and Plasmids for Viral Vectors.
The new Plasmid Manufacturing Unit will replace the existing one allowing production of R&D, High Quality and GMP plasmids addressing all applications: from discovery research through commercial production.
“Anemocyte’s new facility is built with modular cleanroom areas resulting in a threefold higher manufacturing output when compared with the existing one, maintaining the highest possible standard of quality and compliance” said Marco Ferrari, Anemocyte CEO. “The new facility is part of the Exellula project that will also include a third GMP facility aimed to address industry manufacturing needs up to commercial scale.”
Such an increase in Anemocyte capacity and experience combines perfectly with the over sixty years of successful manufacturing stories within the Nine Trees Group strengthening Anemocyte’s unique position as Biotech Manufacturing Organization (BMO) capable to address C&G manufacturing need from discovery clinical research through commercial.
Last February Anemocyte appointed M+W Italy, a leader in pharma/biotech custom engineering and construction, partner for the design and construction of the new plasmid facility.
“M+W Italy is proud to be Anemocyte’s partner for the engineering study and the construction of the new plasmid facility. Our unique expertise will allow Anemocyte to complete the site revamping without any impact on the business continuity ensuring the highest quality standards in the industry” said Ettore Marco Merigioli, M+W Italy Managing Director.
Since the beginning of the project, M+W Italy have supported Anemocyte in the definition of process requirements for new areas development, selecting the best available engineering solutions. Subsequently M+W Italy is driving the new facility construction activities.
EXELLULA project is the first Italian industrial complex entirely dedicated to the development and production of Advanced Therapy Medicinal Products (ATMP) for third parties, and a world centre of excellence for nonviral technologies.
It is an all-Italian investment aimed at creating the most important national manufacturing centre for Cell and Gene Therapies (CGT), one of the most significant private investments in the sector of contract manufacturing of cell and gene therapies currently underway in Europe, with over 2000 square metres of GMP and GMP-compliant facilities for the development and production of Advanced Therapy Medicinal Products (ATMP) and over 500 square metres dedicated to their research and innovation.
Do you have questions about Anemocyte? Ask them in the comments below.