BIO 2019: Biologics GMP Issued to Axis Biotec Subsidiary Silvestre Labs

is a leading Brazilian biotech company focused in research
and development and now in manufacturing of biologic drugs.

The ANVISA, Brazil’s National Health Surveillance Agency – Good
Manufacturing Practices (GMP) certification qualifies Axis Biotec
manufacturing facility in Rio de Janeiro to register, import,
manufacture and also store and distribute biologic drugs in Brazil.

Brazil’s GMP regulations, which closely resemble the internationally
recognized standards for USA and EU, require biologic drug manufacturers
to have a robust quality system for the manufacture, packaging, labeling
and storage of such products.

“Axis is very pleased with the successful completion of the ANVISA
inspection and GMP certification of our Rio de Janeiro manufacturing
facility. Our strict adherence to GMP and our quality systems allow Axis
to provide our clients with a high-quality product,” said Tatiana Lima,
Axis Technical Director. “Our certification from ANVISA, represents an
important milestone for our strategy to nationalize the manufacturing of
biologic drugs in Brazil, enabling broader access to the population and
providing better care for patients,” said Guilherme Goldberg, Axis CEO.

“We will continue to increase our commitment to quality and patient
safety, aligned with our mission,” said Eduardo Cruz, Axis Advisor and

About Axis Biotec

is a private pharmaceutical holding company, specialized in
biotechnology, with focus on deploying commercially viable products and
services resulting from its investments in R&D. It owns and controls
Silvestre Labs, a pharmaceutical company, Cryopraxis, the largest
Brazilian stem cell blood bank, Plantpraxis, a R&D company focused in
vegetal expression of biologics and Cellpraxis, a R&D company focused in
regenerative medicine. Since 2013, Axis Biotec has been involved in
technology transfer and nationalization projects that would enable the
manufacturing of biologic drugs in Brazil. Through partnerships with
originators of biologic drugs and the thoughtful integration of
innovation management and execution capabilities, Axis is strategically
positioned to provide top quality products and services.


Guilherme Goldberg

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