COMPANYPRESENTATION

Anemocyte is a Biotech Manufacturing Organization (BMO)
Offering development and manufacturing services and innovative
solutions from R&D to GMP to address needs in the field of:pDNA

PLASMIDS FOR VIRAL VECTOR
AND RNA MANUFACTURING

ANEMOCYTE / COMPANY PRESENTATIONmRNA

mRNA FOR VACCINES ANDIMMUNO-ONCOLOGY THERAPIES

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OUR WEALTH OF EXPERIENCE

OF GMP MANUFACTURING OF CGTs
AND BIOLOGICAL DRUGS

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Plasmid DNA developmentand manufacturing
Plasmids can be used as ancillary or criticalstarting material for:AAV or lentiviral vector productions to beapplied to the clinical manufacturing ofgene and immuno-oncology therapies;
mRNA manufacturing;clinical manufacturing of biological drugs.

ANEMOCYTE – Plasmid ManufacturingPLASMID MANUFACTURINGHIGHLIGHTSWith more than 500 sqm (about 5,000 sqft), the Plasmid Unit of Anemocyte
addresses the manufacturing needs of Plasmid DNA from R&D to GMP.
All manufacturing steps are available in classified clean rooms.
Multiple segregated areas allow the performance of parallel manufacturing
processes.
Flexible sizing of upstream fermentation 5-200 L (higher volumes are possible)
performed using animal-free medium.
State-of-the-art equipment allows the highest downstream flexibility.

5PLASMID MANUFACTURINGHIGHLIGHTS

MANUFACTURING Highlights

Starting from 1 mg batch size.
QUALITY Highlights

Production and analysis are performed in ISO-certified laboratories.
Most relevant features of cGMP manufacturing are applied (e.g., traceability,document control and materials segregation).
All the equipment for production and analyses are validated (IQ/OQ protocols).
All the starting materials and single-use components are certified as TSE-BSE free.
Majority of analytical assays are performed in-house.
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REGULATORY LANDSCAPE FOR
PLASMID MANUFACTURING
Technology/Products

Starting material

Active substanceIn vivo gene therapy:mRNA

Plasmid,
manufacturing
and linearization

In vitro transcription

mRNA
Manufacturing and purification

Formulation, filling

In vivo gene therapy:
non-viral vector(e.g. naked DNA)

Plasmid,
manufacturing

Establishment of bacterial bank (MCB, WCB)DNAManufacturing, fermentationand purification

Formulation, filling

In vivo gene therapy:
viral vectors

Plasmid,
manufacturing

Establishment of a cell bank (MCB, WCB) and virus seeds
when applicable

VectorManufacturing and purification

Formulation, filling

Ex-vivo: geneticallymodified cells

Donationprocurement andtesting of tissues/ cells

Establishment of a cell bank
(MCB, WCB) for plasmid
and/or vector expansion andviral seeds when applicable

Genetically modified cells
manufacturing

Formulation, filling

GMP Principles
should be applied to
manufacturing steps

Application of GMP to
manufacturing steps

Plasmid Manufacturing

Vector Manufacturing

Finished productSource: Questions and answers on the principles of GMP for the manufacturing of starting materials of biological origin used to transfer genetic material for the manufacturing of ATMPs.

7PLASMID MANUFACTURING
OTHER SERVICES

Process development
Process optimization anddevelopment for different phasesof Plasmids and mRNA production,and for Tech Transfer.

Stability studies
Long-term and accelerated studies
at different temperatures.

Cryopreservation
Storage and cryopreservation
under different conditions.

Secondary packaging
Anti-tampering dedicated boxes.

8mRNA development andmanufacturingmRNA can be used for:

Vaccines;
Immuno-oncology therapies;
Protein replacement therapies;
Genetic diseases.

ANEMOCYTE – Plasmid Manufacturing

mRNA MANUFACTURINGHIGHLIGHTS

MANUFACTURING Highlights

Starting from 0.2 mL batch size (IVT).
QUALITY Highlights

Production and analysis are performed in ISO-certified laboratories.
Majority of analytical assays are performed in-house.

10ANEMOCYTE S.r.l.
Via Roberto Lepetit, 34
21040 Gerenzano (VA) Italy
Ph. +39 02 9937 2311
Fax +39 02 9937 2313
info@anemocyte.com
www.anemocyte.com